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Powering the Voice of Customer Insights Through Real-Time Speech Analytics

For contact centre agents, real-time speech analytics is among the most potent tools to serve customers. Its importance lies in recognizing customers’ exact objective and pushing actionable intelligence. Conventional speech analytics tools rely on spotting phonetics, phrases, keywords and fail to catch the relevancy, context and therefore, the specific meaning or intent of the interaction.

Next-generation, enterprise virtual assistant tools can reveal profound information and offer actionable insights into agent and customer behaviors and expectations.

Moving to Next-gen Speech Analytics

Ensuring an exceptional customer experience has changed, in the eyes of businesses, from an outlay that must be reduced to a critical competitive differentiator. Companies today must collect, identify and act quickly on customer intelligence while augmenting longevity, satisfaction, and profitability. One way that contemporary contact centres have indulged in this complex mission is by adding another level of analysis to the process of data gathering. There is an emphasis on amorphous voice recordings.

Conventional speech analytics tools depend on phonetics and keywords that overlook relevancy and context, which are crucial to understanding what individuals say. Today speech tools are deployed for complex tasks that could fulfil more varied and demanding expectations of the customers. They are progressively using mobile devices, adding to their sense of urgency before and in the course of their interactions. All such shifts lead to more data that can be gathered by the centre and then dug out for insight.

Speech Analytics Versus Voice Analytics

Speech analytics tools revolve around the content of a chat. The solutions are devised to evaluate what was stated by associates and customers, and in what background. It is accomplished through phonetic indexing or by transforming speech into text. The result is a searchable database of what customers and associates said during the conversation.

A customer, for example, makes a call to a service line to register a complaint about an inaccurate charge on a bill. Completing the search for words that the customer speaks such as, “wrong fee” together with a search for the partner saying “settled”, the reason for the chat can be pinpointed and if the customer’s problem was resolved. By tactically identifying phrases used during a conversation, speech analytics assist firms in making informed judgments to enhance quality assurance.

On the other hand, effective voice analytics concentrates on how it was said. Voice analytics considers specific attributes of a speaker’s voice, such as pitch, tempo, and tone to form evaluation and quantify the customer’s feeling.

Exploiting Real-time Speech Analytics for Enhanced Insights into Customer Engagement

AI has substantially enhanced the capabilities of real-time speech analytics tools by augmenting insight generation, measurement of sentiment and tone, speech-to-text precision, and quality management. There are several ways for supervisors and agents to make the most of AI-powered speech and voice analytics to enhance the overall customer journey and customer experiences. Here are a few examples:

Self-managed learning: Speech analytics post a call can also boost employee engagement. It can be done by providing agents access to insights about call performance. Agents can take a look at their performance and make changes, thereby accelerating the learning process.

Agent training: Likewise, real-time voice analytics empowers managers to supervise calls and pinpoint opportunities to offer support.

Guided suggestions: Using voice analytics or real-time speech analytics, agents can get advice to recommend relevant products to customers based on the nature of the call and their mood.

Anticipate Net Promoter Score (NPS): Integrating NPS results with speech and predictive analytics will allow firms to foretell customer responses and expectations.

Better insights on customer satisfaction: Some solutions use deep learning that employs neural nets to provide better insights to detect emotions and to obtain insights from speech.

Alleviate compliance issues and liability risks: Through real-time speech analytics, agents can get reminders about critical disclosures that must be shared before closing the chat.

Fraud detection: AI together with speech analytics solutions, can be taught to evaluate and score calls for possible fraud and alert agents before they publish classified customer data.

Improving customer experience is key to business success. Companies that understand customer intent and expectations and manage to leverage these insights will be successful.

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Measures to execute voice authentication in call centres

Biometric authentication is a security process used to substantiate a user’s identity through biological traits such as voice, fingerprints, retina, and facial characteristics. Voice biometrics software stores this data to validate a user’s identity when that user retrieves their account. As this data is exclusive to individual users, voice authentication is often more secure than conventional forms of multi-factor verification.

With the growing popularity of voice verification, call centers are witnessing gains not only in terms of time saved but also in terms of offering an enhanced customer experience while boosting security at the same time. Voice-bots, chatbots, and contact centers are the key channels where biometric information is used as per a survey conducted by Deloitte.

Steps to Implement Voice Authentication

The key steps to the implementation of voice authentication software are as follows:

Current Authentication Procedure: Before putting in place voice authentication in banks, it is important to know what the current authentication processes are and how voice biometry will replace the current authentication steps. Why it is being introduced also must be made clear. Some banks wish to have voice authentication to help with conformity, while others want it to cut verification time.

Agent Skilling: Once voice authentication is introduced, agents will have to alter their behavior. They can start by substituting knowledge-based inquiries with voice biometrics. This will not only save time, but they can also immediately start helping clients. It eliminates routine recurring tasks and once they commence using the latest system, they will instantly see the benefits. The voice authentication system can plug into the call center software and show an agent whether a caller is verified or not using a color signal. If an imposter is discovered, a system of escalation must be specified. Call scripts for agents must be employed both at the time of registration as well as voice verification.

Customer Experience & Scam: Clients should assess customer experience at the outset through different metrics, and then compare after execution. They must know where they are at present and where they wish to make progress. When it comes to the risk process, it is important to know the projected fraud size before implementing voice authentication. Key questions on the security that will be achieved by implementing it needs to be answered.

Technical Factors: Since it is a joint process, the biometric vendors work with client development teams or external agencies. The client is aware of how call center infrastructure methods work, and they recognize voice biometrics. So, through collaboration, they determine the ideal way to execute, while realizing the boundaries of biometrics, offering use cases, and examining risks.

With the introduction of voice authentication, there will be a substantial reduction in call length. Firms can avoid paying contact center agents to ask the same questions again and again. In addition to saving call time, voice authentication offers other benefits such as compliance, fraud prevention, fast install time and seamless customer experience.

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All You Need to Know About Pharmaceutical Quality Control

Quality control is one of the most essential operations of the pharmaceutical industry. This is because drugs that are developed must be marketed as safe and therapeutically active formulations, having consistent and predictable performance.

What Does Pharmaceutical Quality Control Mean?

Pharmaceutical quality control is a detailed system of inspection and control covering the production, evaluation, and distribution of every drug manufactured. It refers to the sum of all procedures undertaken to ensure the purity and identity of a particular pharmaceutical product. These procedures may range from simple chemical experiments being conducted to test the presence of a particular pharmaceutical substance and determining their identity to more complicated requirements like pharmacopeial monographs.

Role of Pharmaceutical Quality Control

The purpose of pharmaceutical quality control is to assure the physicians, pharmacists, and consumers that a given medication performs in a uniform and satisfactory manner for which it is recommended. The quality of a product might deviate from the required standard hence, carrying out an analysis is important to determine the quality of the product. The testing of pharmaceutical products involves chemical, physical, and sometimes microbiological evaluation.

The purpose of quality control in the pharmaceutical industry is to ensure:

Efficacy

Safety

Quality

Compliance

Pharmaceutical quality control is required for:

Raw materials and API (Active Pharmaceutical Ingredient)

Packaging components

Finished products

The modern methods of marketing pharmaceuticals are quite unique in comparison to other consumer products. While it is true that most drugs for self-medication are sold freely in pharmacies, most therapeutic agents can be bought only by providing a prescription from the physician. The role played by a pharmacist in preparing and compounding drugs of various types has gradually been replaced by the pharmaceutical industry, providing a diverse range of drugs in a finished dosage form. Due to this development, the responsibility for the control of the quality of drugs has shifted to a competitive free-enterprise industry.

All the requirements pertaining to pharmaceutical quality control must be examined considering the importance of the pharmaceutical industry to the health and welfare of the nation. A range of products belonging to the pharmaceutical industry is life-saving and essential for the well-being of both humans and animals. Such a huge responsibility imposes significant moral obligations on the manufacturer to market safe drugs having uniformity.

Quality control is equally important in the Biopharmaceutical process development, a process that focuses on the development and approaches in providing regulated and cost-effective manufacturing of biologics in a timely manner. Good manufacturing practices ensure the manufacture of drugs equipped with purity, strength, identity, and quality. The Biopharmaceutical process development scientists play a major role in coming up with new or improved methods to optimize the manufacturing process and implement quality to ensure that the products manufactured are of the highest quality, safety, and standards.

Quality Variations

Quality variation may occur due to an error made during the process starting from the reception of raw material to the arrival of the final product in packaged form. The risk of error increases with the increase in material, making the method of quality control quite complicated. Some of the common factors causing quality variation in products are:

Variation in materials used

Variation in the equipment of the same process, the difference in adjustments of the equipment or usage of old equipment

Conducting wrong or inappropriate procedures or negligence in any procedure

Lazy, weak or careless workforce or men having inadequate training or understanding

Objectives of Pharmaceutical Quality Control

The most important objective of quality control in the pharmaceutical industry is to ensure the production of high-quality and safe products.

Pharmaceutical quality control also helps in analyzing the extent of quality variations.

Quality control plays a vital role in evaluating the methods and processes of production.

Pharmaceutical quality control accelerates the sale of products with the supply of only high-quality products.

Its goal is to create quality consciousness at all levels in the organization.

What are the Steps Involved in Pharmaceutical Quality Control?

Examining the quality of raw materials: The quality of a product is determined by the quality of raw materials used in its manufacture. Hence, it is very important to test the quality of raw materials.

Setting up standards and specifications: To make the process of quality control successful, predetermining standards and specifications is extremely important.

Keeping an eye on production operations: For executing efficient practices, it is important for the quality control department to keep an eye on operating methods.

Maintaining the quality of equipment: The quality of equipment or device used plays a huge role in determining the final quality of the product. Hence, their quality needs to be maintained.

Maintaining records: The quality control department also helps in setting records in relation to quality inspection and control.

Ref: https://medium.com/@renytamang1122/all-you-need-to-know-about-pharmaceutical-quality-control-5e8665998f

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Why Analytical Method Development and Validation is Critical to Pharmaceutical Development?

Analytical method development and validation can be referred to as continuous and inter-dependent tasks linked with quality control, R&D, and quality assurance departments. Analytical method development and validation are one of the most important elements of any pharmaceutical program. Although analytical method development is considered to be routine work, it is quite beneficial in contributing to the overall development time and cost efficiency of the pharmaceutical program.

What is Analytical Method Development?

Analytical method development refers to the process of choosing an appropriate procedure to determine the composition of a formulation. It is a process that proves that an analytical method is acceptable to be used in the laboratory to measure the concentration of subsequent samples. Analytical methods are meant to establish the identity, purity, potency, and physical characteristics of drugs. Analytical methods are developed to support drug testing against specifications during manufacturing, quality release operations, and long-term stability studies.

Analytical method development is an uninterrupted procedure that advances simultaneously with the progression of the drug product and the aim of this procedure must mirror the stage of drug development. As the procedure of drug development evolves, the analytical methods are expanded and refined based on enhanced drug product knowledge and API. One thing that must be kept in mind while carrying out analytical method development is that it should meet the appropriate regulatory guidelines without being feeble and complicated.

Validation of the Analytical Method

The validation of an analytical method determines the scientific soundness of the measurement or characterization. It demonstrates that an analytical method is measuring the correct substance, in the correct quantity and in the appropriate range for the intended samples. It helps the analyst to understand the behaviour of the analytical method and to establish its performance limits.

To perform the validation of an analytical method, laboratories must follow a written standard operating procedure (SOP), describing the process of conducting the validation. Using qualified and calibrated instrumentation with a corresponding operating SOP is a must for laboratories. The type of analytical method and technique used determines the nature and extent of the validation studies. Assay, identification, and determination of impurities are some of the most common methods used for validation. The validation method includes various validation parameters. Some of them as recommended by the FDA, USP, and ICH are as follows:

Specificity

Linearity and range

Precision

Accuracy

Solution stability

Limit of detection

Limit of quantification

Robustness

Need for Analytical Method Development and Validation

While analytical procedures play a very important role in uniformity, management of risk assessment and establishing product-specific acceptance criteria and stability of results, the validation method helps in demonstrating whether the analytical procedure is suitable for the intended purpose. Hence, analytical method development and validation are quite beneficial in improving precision and reducing biased errors. They can also further assist in avoiding expensive and time-consuming exercises.

Analytical method development and validation are crucial to pharmaceutical development because of the following factors:

• International competition

• Maintaining the standard of products in high commercial and market value

• Ethical reasons

Challenges

A holistic approach is extremely necessary for an analytical method development and validation process to be successful. However, one challenge that is often encountered when carrying out these processes is that the analytical method is usually developed by the R&D department while validation comes under the responsibility of the quality assurance and quality control team. Hence, it is significant that all groups work as one team.

In addition to this, the methods of analytical development and validation are not robust enough. As a result, if robustness is not introduced into the method early in the development phase then there is a high probability that the results will lack efficiency in quality testing thus, resulting in a lengthy and complicated validation process.

Analytical method development helps in understanding the critical process parameters and minimizing their influence on accuracy and precision. The validation method, in contrast, substantiates the analytical method for a variety of concentrations so that alterations in concentration or formulation do not require further authentication.

Moreover, the validation method helps in producing results in known uncertainties. These results are extremely important for continuing the development of drugs as they define the emerging knowledge base pertaining to the product. All these factors make analytical method development and validation crucial for pharmaceutical development.

ref: https://medium.com/@renytamang1122/why-analytical-method-development-and-validation-is-critical-to-pharmaceutical-development-8406e9ab6ef4

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Quick Guide on the Current GMP in Clinical Manufacturing

America’s Food and Drug Administration (FDA) is the regulatory authority for checking the quality of pharmaceuticals. The primary regulatory standard for safeguarding pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for medicines. Users expect that each medicine batch they take will fulfil the quality standards.

All new drugs have to go through several phases of trials before it can be sold in the market. Phase 1 clinical trials mark the first time a new drug is tested on humans, these experiments are subject to strict current Good Manufacturing Practices to ensure patient safety.

What are CGMPs?

CGMPs offer systems that guarantee proper monitoring, control, and design of manufacturing facilities and processes. Strictly observing cGMP clinical manufacturing regulations ensures the strength, identity, purity, and quality of drug product manufacturing services. It ensures that manufacturers sufficiently control their operations. This involves acquiring proper quality raw materials, forming robust quality management systems, establishing strong operating practices, examining product quality variations, and preserving dependable testing labs. This strict system of controls at a drug company, if sufficiently put into practice, can prevent instances of mix-ups, contamination, failures, errors, and deviations. This guarantees that drug products fulfil their quality standards.

The Role of the Quality Control Department

The Quality Control (QC) unit handles the process of controlling and testing in-process samples, raw materials, end product release testing and also scrutinizes out of specification or unexpected results. Test methods must adhere to written techniques to assess certain qualities such as strength, identity, purity, and potency. Proper documentation must be kept for all test results, procedures, and changes to procedures.

A Certificate of Analysis (COA) is circulated for each batch of the drug product that shows that the substance fulfils the stipulated approval criteria for each of the characteristics analyzed. At this juncture in the growth pathway, certain traits or acceptance norms might not have been defined yet. Representative samples of the fabricated drug product lot must be placed in a conventional stability study, according to a written protocol to assess the product qualities as a function of temperature, humidity, and time.

Drug firms must have proper documentation outlining the roles, tasks, and training for QC personnel and also for maintenance and calibration of lab equipment as appropriate.

The QA team is accountable for forming and preserving quality systems and evaluating out of order results and any remedial and preemptive actions executed for clearance of the end product and preserving the completed batch records, among other tasks.

The batch record must illustrate the component records, materials, procedures used, equipment, and issues noticed during production, including variations and probes, and must be comprehensive enough to be able to effectively replicate the manufacturing function. The batch record must also verify whether a run was dismissed and the possible causes.

Why are CGMPs so Critical?

A user often cannot identify whether a drug product is dangerous or if it will be effective. While CGMPs involve testing, it is not sufficient to guarantee quality. Often testing is performed on a small sample of a batch to ensure that the medicines in that batch are used for patients instead of being ruined by testing.

Therefore, it is essential that drugs are produced under circumstances and procedures necessitated by CGMP regulations to guarantee that superiority is built into the manufacturing process at each step. Centers that are in decent condition, equipment that is suitably calibrated and maintained, workers who are fully trained and qualified, and methods that are dependable and can be reproduced, are a few instances of how CGMP prerequisites help in assuring the efficacy and safety of drug products.

In brief, makers of clinical trial material must have at least the following:

A quality system that keeps organized documents, operates checks of completed documents, probes and CAPA’s and delivery of finished drug products.

Testing methodologies and lab controls that make sure the products fulfil predefined quality requests.

Facilities that are sanitized, regulated, and kept in a calibrated state, as deemed appropriate.

A production process that establishes control of procedures and produces reproducible results.

FDA carries out widespread public outreach through seminars at national and international conferences, to talk about and describe the CGMP requirements and the latest policy documents.

ref: https://medium.com/@renytamang1122/quick-guide-on-the-current-gmp-in-clinical-manufacturing-b13c599ac03f

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Accelerating Drug Development Through Biologics Process Development Services

Irrespective of the industry, it is commonly known that firms that are slow to adapt always lag behind their nimbler competitors. This allows them enough room to control the market even with inferior products even if slow-moving firms offer enhancements over what is available in the market. Fast movers are open and flexible to a lively business environment. They take advantage of opportunities and steer through challenges and risks by reacting quickly to adjustments and often even anticipate them. 

In a few industries, pace can be attained through project management streamlining, supply chain compression, outsourcing, automation, internet/cloud-based collaborations and inventory control. There are a few businesses who have the choice of putting out “lowest feasible products” just to be the first and subsequently enhance them for successive releases. Such tactics might work in drug product formulation development to contrasting degrees.

“Speed-to-market” is a phrase which is often used for various industries. The enormously regulated healthcare market won’t accept distribution of products that give in to efficacy, safety, or quality. 

In fact, the majority of drug candidates that go into the development phase will not be successful. And of course, a few drug support decision-makers may see guidelines as hindering their ability to function — until, possibly, they find themselves in need of some critical medicine for their individual health, when certainly they will be expecting that product to be as reliable as it can be.

Once a drug candidate is in the clinical development phase, speeding up its progress to market involves performing chemistry, manufacturing, and controls (CMC) activities to make it ready for the third phase as early as possible.

Outsourcing to Siloed Vendors

Another effective way to accelerate drug development is through outsourcing, which has become more and more tactical, as drug firms continue to subcontract specialized functions that traditionally were done in-house. Consequently, outsourcing firms have become siloed along operational fields, leading to an abundance of companies that focus only on activities such as discovery biology, discovery chemistry, preclinical safety and toxicology, formulation development and manufacturing, and clinical testing.

To continue a drug development program in the traditional outsourcing style, the developer must engage with several vendors—a necessity that generates a substantial management responsibility, as there is hardly any communication between vendors. For instance, the Contract Development and Manufacturing Organization (CDMO) will rarely have a chat with the Contract Research Organization (CRO) and could have a partial understanding of the endpoints and clinical trial design the customer intends to deliver against. Likewise, the CRO might have limited understanding of where the drug is coming from or its weaknesses and strengths in terms of how it operates in humans.

This very siloed and labored approach leads to very little functioning synergy between vendors, giving in the pharma corporation's ability to revolutionize the drug development process. Yet even with the constraints of this traditional approach to outsourcing, the process has continued unchanged for the last 10 years.

Failure is an Option

Biopharma firms have to maintain a balance between the positivity of working ahead and the practicality of acknowledging failure as an alternative. Based on who is making the assessment using which benchmarks, at least 50% of all drug candidates discovered during lead optimization will fail to pass through the clinical phases to market. Such setbacks develop as a process of attrition in the general drug pipeline and generate cost pressures as the products that do thrive must earn sufficient money to make up for those that do not. 

In a biologics process development services framework, methodical, cross-functional evaluations raise the enquiry on R&D programs with time, with important decisions made at each key project milestone to evaluate “what has been accomplished, whether it is adequate, and based on the data available if the project can be authorized to the next stage. This lets corporate management to stop or halt a project entirely to prevent resources and effort from being squandered on ill-fated products.

Technologies such as automation and single-use systems, high-throughput analytics and screening and uninterrupted processing are facilitating biopharma firms to contemplate reducing their timelines. But accomplishing that depends on adopting a tactical approach, making use of platforms and prior experience, managing risk and involving cross-functional groups in decision-making.

Ref: https://medium.com/@renytamang1122/accelerating-drug-development-through-biologics-process-development-services-507c0c392afb

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Key Differentiators in AI Solutions for Contact Center in the New Normal Era of COVID

The arrival of Covid-19 has pushed contact centers worldwide across industries beyond their limits. Customers, as well as employees, are anxious and care staff are undoubtedly feeling the burden. In the airlines and hotel industry, the pandemic led to a spate of refund requests and cancellations. In other sectors, it led to a rush in demand. For instance, call centers in food retail are overwhelmed as people look for home delivery slots.

While the workload is mounting, several contact center agents are being forced to work remotely. The combination of relocation, the move to a distributed workforce, and high demand have presented a huge challenge to agents. As economies gradually shift to a new normal while following safety measures, we are observing how digital and AI contact center solutions are keeping several firms afloat, allowing them to get ready for what lies ahead in a post-Covid-19 age.

With the Covid-19 crisis dragging on, short-staffed grocery stores, financial services, and government agencies are all scrambling to set up an AI-based real-time speech analytics solution to handle the growing inflow of calls. Companies like IBM’s Watson Assistant and Google’s Rapid Response Virtual Agent have seen an increased demand from a large number of clients.

Enhanced Customer Experiences through Agent Augmentation

Contact center agents today are under immense pressure to answer complex customers queries especially concerning Covid-19 within a matter of a few seconds. Customers are impatient and expect to have instant answers to their queries, without having to go over their questions to innumerable advisers.

Luckily, AI can accelerate the solution for customers and agents on a real-time basis by developing appropriate information and support for an adviser answering a call. Through agent augmentation strategies, AI can instantly deliver sales data to an agent about a customer so that they are ready with a more contextual chat. For instance, they may get a pop-up message from the AI before an agent answers a call that shows:

Products or services that they have

Agents that they’ve worked in the past

Prior complaints

Prior purchases made with the company

The customer’s name and background

Once an agent answers the call, the virtual agent can remain in the background and draw extra information when keywords are stated or offering helpful ideas. Some advanced agent augmentation strategies could even consist of things like natural language understanding to evaluate the sentiment of a chat.

For example, if the AI finds that the customer is becoming upset, it will offer suggestions on how the agent can fix the discussion and cut the risk of further problems. A few agent augmentation programs can even analyze chats and determine when to speak to a supervisor on behalf of an agent.

The Role of Conversational Analytics

In the midst of the current emergency, several healthcare, insurance and government organizations are turning to conversational analytics tools to handle the surging customer calls about COVID-19. These solutions offer the potential for curated data that can be tailored to the needs of the individual. Responses to certain questions can be presented in a collaborative manner more quickly than conventional online search methods.

The information can be adapted easily to local regulations and guidelines, based on the user’s location. In addition to all the benefits, there are a few shortcomings that need to be addressed. For instance, companies must ensure data privacy and security at the vanguard of adoption and usage guidelines to preserve the public’s trust in the information the chatbots deliver.

Voice Verification

Another key strategy in the post-COVID era is the progress of voice channel security in contact centers. The complexity of cybercrime and social engineering attacks will improve over time, so the application of pioneering security steps to protect a voice channel is essential. For contact centers, voice verification is the only alternative to strengthen voice channel security. It uses advanced voice biometrics tools to combine an additional layer of security to telephone communication with customers.

Voice verification lets contact centers save 20 to 90 seconds on the Average Handling Time by reducing the Knowledge-Based Verification (KBV) stage of a call. This happens through real-time analysis of a caller’s voice, permitting a call center operator to verify a caller in a few seconds and identify fraudulent behavior. Voice verification encourages a smooth customer experience and improves the NPS.

In the future we will see voice bots that will automate a substantial number of voice interactions, offer a unified customer experience supported by a secure voice channel and human operators complementing conversational AI to offer humanity with a wonderful voice-first experience.

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How Conversational Service Automation is Solving Customer Problems During COVID-19

Customer service centers worldwide are facing an extraordinary rise in overall call volume due to the widespread transmission of COVID-19, which has disrupted workplaces. Several travelers are looking to modify their schedules while banks and credit card firms are witnessing longer-than-average hold times, with many customers experiencing call drops. For call centers, Coronavirus’ impact has raised deploying a chatbot to the top of the “to do” list.

To cope with this unprecedented burden, several organizations are adopting AI to fill the gaps in service. The solutions offered are not flawless and there will always be a necessity for humans, even when chatbots are installed, but the pandemic has fast-tracked the need for voice authentication software and AI-powered contact center messaging.

Even earlier, businesses turned to AI to bridge gaps, scale customer services, and cut costs. Chatbots are also evolving and are able to carry on prolonged conversations, in contrast to their previous avatars.

Conversational AI unites into the call center mix and raises chatbots to a different level altogether. Conversational AI delivers a lot more than just simple answers as they perform complex tasks, make recommendations, fill out forms, set up new accounts, talk users through processes, and much more.

Augmented Agents

Customers get annoyed when service agents fail to provide definite, reliable answers to their questions because they do not have the right information. No amount of compassion and appreciation will help if agents do not have the expertise to reply to customer queries. Consequently, brands must augment the qualities of agents with AI-based technology, giving them the encouragement they need to concentrate on empathy and solve complex problems.

Systems that spontaneously scan inbound digital communications, such as social media messages or email and propose appropriate responses to agents not only facilitate in delivering faster, more beneficial service, but empower them with the expertise they require to fulfil customer needs.

How Automation and AI can help Call Centers Fulfil Customer Demands

Conversational Service Automation solutions offer a cost-effective and quick way for companies to better handle rising call center demand and sustain high levels of customer service even during a disaster.

A voice authentication software solution can be deployed in a few days to answer customer queries, prioritize them as per urgency, and act in response to pressing issues so all calls are resolved, giving live more time to address complex matters.

An Ai-powered voice authentication software works by:

Answering customer calls immediately without putting them on hold

Responds to ordinary queries automatically, without the interference of live agents

Categorizes calls based on urgency and subject matter, so organizations can prioritize follow-ups to work out complicated issues.

Conversational AI applications persuade folks to discuss more about what exactly they are seeking than chatbots. This generates vast quantities of data that they can use to individualize the discussion further and provide actionable insights to the business.

Conversational AI Offers Greater Capability

Assimilation into processes and backend systems allows conversational AI apps to offer a more appropriate and tailored response to customers. From getting back specifics of previous orders to calling on a Robotic Process Automation to operate a particular task, businesses can deliver a superior customer experience by making full use of existing systems.

How Conversational AI Offers Easy Collaboration Among Teams

Several businesses have teams in different sites working on the same projects, but with people confined to working remotely, a functionality on collaboration such as user control is vital in a conversational AI development program.

Besides, it’s also essential that teams have visibility into the genuine app including the ability to interpret. Specific platforms must be developed to allow business users and developers to work together to recognize points that may need adjustment to bring in accordance with business practices.

This feature becomes even more critical in the current pandemic to ensure that other staff can take up a project immediately should a team member gets sick while looking after family members.

Ref: https://medium.com/@renytamang1122/how-conversational-service-automation-is-solving-customer-problems-during-covid-19-6093a5ef86d

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Understanding the Fundamentals of Analytical Method Validation Services

Analytical method development and validation are the inter-dependent and perpetual tasks linked to R&D, quality assurance and quality control departments. Analytical methods play a key role in risk assessment and equivalence management. It guarantees the stability of results and the formation of product-specific acceptance criteria.

Validation must establish that the analytical process is appropriate for its envisioned purpose. Design of experiment is a potent tool for validation and method characterization. Analytical experts must be comfortable while using it to optimize and characterize analytical methods. A powerful validation and analytical method development process can offer major enhancements in accuracy and a drop in bias errors. It can also help avoid time-consuming and expensive exercises.

Analytical Method Validation

Analytical method validation services and transfer are the fundamentals of a pharmaceutical development package. These are the crucial ways that ensure biotherapeutics, drugs, and other products made by firms in the biotechnological and pharmaceutical sector fulfil acceptance criteria. Habitually considered repetitive, the advantage that a properly developed analytical method can provide to general cost efficiency and developmental time for a program is underrated. 

Acceptance criteria are built on the test process being used and the kind of product being examined. Analytical methods are carried out to test the purity, efficacy, potency, identity, and concentration of finished products and in-process samples.

Method-related events are interconnected as well as cyclic mainly during the initial drug development stage. Parts of each procedure might happen simultaneously or be refined at different stages of the drug development process. Modifications to one technique during the drug development process may entail changes to a current analytical method. These changes, in turn, may necessitate further transfer activities or validation.

Analytical Method Qualification 

Analytical method qualification is closely linked to analytical method validation. In fact, the terms analytical method qualification and analytical method validation are essentially identical within the sector. Analytical method validation’s purpose is to authorize and record whether the method is working as intended. Regardless of any previous qualification or validation work done for potential methods, each time a method is installed, created or transferred on an existing system, it must be authorized. Comprehensive validation packages will be formed and implemented.

Elements of Validation

Analytical method validation establishes the scientific dependability of characterization and is needed during the process of regulatory submission. The validation exercise authenticates that an analytical method measures the right ingredient, in the right quantity, and in the proper range for intended samples. It allows the expert to comprehend the behaviour of the technique and establish the method’s performance limits. 

To carry out method validation, the lab must follow a mandated Standard Operating Procedure that defines the method validation process. The lab must use calibrated and qualified instrumentation with an equivalent SOP. 

A documented and well-developed test method should be put in place and permitted guidelines must be followed before carrying out validation experiments. The guidelines must define the method by which performance parameters will be verified, how the parameters will be evaluated, and the applied acceptance criteria. Lastly, samples of drug product or API, reference standards and placebos are required to accomplish validation tests.

Approaches to Validation Experiments

Accuracy will be maintained by spiking placebo with API for a drug or sample quantitation against a reference standard for API. It can also be decided by comparing results from different measurement procedures.

Accuracy can be decided by several measurements on a homogeneous and reliable set of samples. Samples can be evaluated by different analysts, on different days, on different apparatuses, or in different labs. There are 3 levels of precision validation assessments – intermediate precision, reproducibility, and repeatability. 

Intermediate precision is a measure of accuracy within the same lab by different workers, using different apparatuses, and taking measurements on different days. Repeatability is a measure of accuracy under similar conditions over a short period. Reproducibility measures precision between two or more labs.

The variables mixed up in analytical method development are as distinctive as the abundant biotherapeutics and drug products we see in the market. Analytical method development is defined by the product being created, which is then examined. Based on the product, phased method validation strategy or early-phase method validation may be employed.

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All You Need to Know About Contract Formulation Development

Outsourcing or subcontracting the process of drug development is a flourishing trend in the biotechnology and pharmaceutical industries. Drug companies are under immense pressure to take drugs candidates from invention to clinical trials on humans as fast as possible. As a result, several biotech and pharmaceutical firms are outsourcing parts of the drug development process.

Outsourcing reduces product development timelines and offers a cost-effective option to add dedicated resources. Shifting needs in the existing fast-tracked development ecosystem determine that resources must be tailored swiftly to fulfil demands. Consequently, subcontracting offers a flexible cost structure, boosting resources and spending when needed and lowering when demand recedes.

Drug product formulation development is a significant area of product development that can ascertain lifecycle, patentability, and the triumph of a pharma product. Companies combine personnel and contract formulation development functions into their product development cycle in various ways. In fully integrated sizeable pharmaceutical firms, individual departments may be present to handle areas such as formulation issues and physical characterization of drug substances.

In multiple instances, other units, often in other locations or buildings, may carry out preclinical tasks, such as animal testing. These departments work closely to obtain awareness of their drug substances.

Drug Formulation

One of the key aspects of pharmaceutical formulation often ends up about a combination of pharma technologies, including tablets, capsule matrices, excipients, parenteral co-factors, time-release components and so forth will yield a product that demonstrates efficacy and a high degree of safety.

Formulation is the process wherein different biochemical and/or chemical substances, including active drugs are combined to make a final medicinal product. Formulation is used in a manner that comprises not only manufacturing inputs and process but also the decisive product dosage form. The end product dosage form is what patients finally experience and should persuade them to be compatible with their dosing regimen.

Types of Projects

Formulation development comprises a wide range of activities. Conventionally, it covers functions like excipient screening to enhance the solubility of the product, analytical assay development and characterization. Formulation development might also include evaluating delivery device compatibility and delivery options.

Projects usually fall into two distinct classifications, those that have been designed completely as outsourced activities from the beginning and those that involve outsourcing services to solve a product development problem. The project could be thorough with long-term objectives or leaning toward short-term goals, such as finding out why a molecule is accumulating.

There are several challenges that may arise at the time of product development such as low bioavailability in animal studies, incompatibility with the desired delivery system, low drug solubility in an aqueous environment, and a multitude of stability concerns. For these challenges, firms may look for help from outside. Occasionally the crisis can be resolved effortlessly with a new set of eyes to examine a long-standing problem. Other impediments involve more work, possibly even thinking outside the box.

The effectiveness of a drug, the form of the dose and the price of therapy can have an extensive impact on the patient’s expectation & awareness of the drug’s function and placebo. Drug pricing is on the edge of formulation because when looking from a distance, the price influences accessibility and can impact patient-reported results. So, valuing could be deemed a component of the formulation, that will, in the end, influence what the patient gathers from therapy.

Ultimately, drug formulation must consider all the key components mentioned above, including final dosage form to boost patient compliance.

Formulation development projects range from the mundane to the complicated. The practice of recognizing the best outsourcing partner for a project may be simplified by soliciting a string of questions internally before looking for a partner. A conclusive project plan in terms of scale, timelines and objectives will help the outsourcing partner get a realistic idea of detailed proposals and cost estimates.

The better the up-front message, the better headway the project will make. This will help the contracting partner to stick to the 3 “D”s of project commitment: Dollars, Deadlines and Deliverables. Formulation will remain a key drug development area. As the outsourcing trade grows, there will be an upsurge in the advent of firms to address the niche product development requirements of both pharmaceutical and biotech firms.

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Impact of COVID-19 on Customer Service

Coronavirus or Covid-19’s influence is being felt by organizations worldwide. Leaders are coping with a wide range of interconnected issues spanning employee and customer safety, reorienting functions, driving complex government support programs, and shoring-up cash and liquidity. How the pandemic is impacting different parts of the business contrasts intensely from one department to the other. 

On one hand, finance is coping with critical cash management problems, on the other, HR is dealing with blunt choices about layoffs and furloughs. While the sales department is struggling to persuade customers to continue purchasing even as funds are drying, IT is trying to urge employees to be more productive as they work remotely.

One department which has been hit the hardest is customer service. Several people have been calling to deal with issues concerning the pandemic — from clashes over insurance coverage to unforeseen travel cancellations and pleas for bill payment postponements. There has been a dramatic increase in the level of concern in service calls, making the job of representatives even more challenging.

Alert Customer Service in Periods of Change

With the emergence of Covid-19, brands must reassess how to leverage contact centers, how employees can offer superior customer experiences, where they work, and how digital media can be used to sustain growing contact center volumes. Leaders must make quick and informed decisions to back their employees while earning and upholding customer trust.

Augment and Automate Service Through Virtual Assistants

Currently, customer contacts are at a peak. There are industries experiencing customer intents precisely with respect to Covid-19. The sustained disruption of the daily routine is leading to spikes in other inquiries such as travel cancellations, unemployment benefits payment extensions, late fees, and stock inquiries, with fluctuating urgency levels.

Artificial Intelligence in customer service has, therefore, become very important. With growing volumes and the disruption of the contact center workforce, now is the time to consolidate on AI and develop a combination of multi-speed machine and human workforce. Virtual assistant solutions, built using AI & Machine Learning technology, provide customers prompt, on-demand service. They deliver a conversational experience, offer automated support, and can manage properly as any human agent. 

They can comprehend and fulfil individual customer needs. Irrespective of their maturity, businesses can still harness enterprise virtual assistant solutions to release the burden on contact volumes.

Key Actions to Best Fulfil Customer Demand During the Entire Period of Covid-19 

Here are a few steps that will ensure the demands of customers are fulfilled:

1. Make use of collaboration tools that deliver virtual field service with the help of pictures and video chat and create more proactive communications as guidelines evolve.

2. Trigger and supplement alternate support networks. Recognize the needs of customers that can be shifted and grow awareness of other possibilities. Queue messaging can be used to move customers straight into other channels, such as virtual agents, digital, and asynchronous messaging.

3. Use your personnel differently by making small changes to the operating model to fund the right mix of reactive and proactive customer needs, move agents to support outbound and inbound contacts and find out customer preferences for communications as COVID-19 advances.

4. Resolve the issues of critical contacts before handling the less urgent but important contacts with tools like callback assist. Make use of analytics to notify workforce planning, adjust distribution and prioritization logic on current platforms, and modify IVR messaging and menus.

Once businesses have all the capabilities in place, they must focus on the following activities:

Reinvent the future. The environment currently is hastening future trends. Post this pandemic, businesses will have to build on their competencies. They will have to prioritize things aligning with long-term corporate strategies and modernize solutions that can withstand in the long run.

Scale swiftly. No capabilities can be built flawlessly in an instant. When you implement virtual assistant capabilities or contact center analytics, certain solutions must be put in place.

How we respond to this pandemic will determine the future of customer service in terms of agent agility and workforce management. As experts are still clueless about the time it will take to stop the virus from spreading, leaders must do something for the short-term while coming up with new capabilities that could enable long-term operational changes.

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How Speech Analytics is Proving to be Valuable in the Covid-19 Crisis

With the onset of Covid-19 and the rapid spread of the virus, most industries are witnessing a drastic change in the way customers and businesses are conversing with each other. It all began with passengers calling airline operators about the cancellation of their flights and refunds. Even insurers and healthcare facilities are inundated with customer queries. When it comes to the retail industry, the question they are facing is around the availability of products and safety measures being taken.

Millions of people are facing financial constraints either because they have lost their job or because their pay has been delayed. These people are reaching out for support from the banking sector as well as the government with new and arbitrary issues.

Coming up with answers to such queries in the most well-organized, compassionate manner is a huge challenge, particularly when your team is dispersed everywhere. If the supervisors are unavailable to help the team answer tough questions, they are likely to struggle.

Challenges Contact Centers are Facing Today

The Covid-19 pandemic has created the following challenges for contact centers:

Out-of-contact self-service: Self-service arrangements in contact center solutions need constant updates and substantial adjustments to handle the intricacies and fast change that Covid-19 has introduced. Today these contact centers need to carry a new crisis-oriented and digitally empathetic tone.

Call surplus: Today customers are opting for voice networks over self-service. As we practice physical distancing, customers wish to chat with humans, specifically while dealing with life-changing situations. Many firms are witnessing call volumes grow 50% and more while they were sending staff home. Today, calls are getting longer and are often linked to critical matters.

Analytics Solutions Demonstrating Value in Uncertain Times

Speech analytics solutions can easily be used to handle rising inbound call volumes. Even as several contact center agents were transitioning to working remotely many firms were able to respond to calls for payment extensions, due to surge in unemployment.

Speech analytics can potentially aid firms during these uncertain times that will help them comprehend the causes behind the enlarged call volume. Speech analytics solutions can also help determine when to expect payments and guess inbound arrival patterns.

The short-term results show that companies were able to redirect resources from outbound dialing, keeping call abandonment rates under control even with agents working remotely. Besides, speech analytics supports quality disclosures and agent compliance. It also removed manual letter provisions and recognized web content that required updating, in addition to other process improvements.

Assistance for Customers

Speech analytics solutions have aided leading businesses to cut working costs, implement regulatory compliance, locate and help address knowledge gaps, boost customer satisfaction and empathy, diminish customer churn, and raise revenue.

Today, these solutions are aiding firms to help their customers cope with this crisis. Together with solutions that record customer calls, speech analytics solutions examine all calls and cleanse the results into insights that divulge the following details:

Key reasons for customer frustration and confusion

The critical concerns and questions customers are calling for

Modifications to digital and self-service channels that must be considered

Equipped with this information, businesses are able to recognize key issues that are undeniably mission-critical. Such calls will be addressed by agents who can soothe customers’ concerns, show them the way and offer data on all new initiatives addressing their anxieties. Speech analytics solutions can also recognize customer confusion flashpoints and resolve the root cause of such concerns.

Assistance for Agents and Businesses

Speech analytics solutions can help ensure that there is no disconnect between frontline employees and media initiatives, particularly when guidance and policy changes so often. It can also securely align the content on digital networks with the content contact center agents share with customers. The solutions can stop customer attrition by offering insight into 3 key areas:

The modifications needed to sustain employees and, eventually, the business.

The prominence that often supervisors and managers lack to guarantee effectiveness, compliance, and quality.

The difficulties that affect work-at-home members’ ability to serve customers

Your customers will remember all about these extraordinary days, and how they were dealt with by companies and the support they received, and speech analytics tool will go a long way in addressing their concerns.

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Accelerating Global Biologics Process Development Services

Quick turnaround is crucial for any drug development process starting from R&D, clinical trials and pushing them to the market. Businesses ranging from small biotech firms to large pharma companies are trying relentlessly to reduce development time and obtain speedier approval for high quality, lifesaving drugs and therapies.

Biologics, such as fusion proteins, antibody-drug conjugations, and monoclonal antibodies present time-consuming and unique challenges when seen against our shared goal to speed up regulatory and development approvals. Biologics process development services add an additional complexity level, wherein aspects such as biologic instability, cell line and analytical development, limited capacity, and scale-up may have a negative impact on budget outcomes and time to market.

Strengthening process productivity, bringing products to market faster, cutting cost, and alleviating risk are some of the issues often addressed. But with support in cGMP manufacturing, training, and process development, speeding up bioprocess development can become less daunting.

Biologics are characterized by their production process that requires comprehensive awareness through conventional process characterization. It is a key component of process validation and signifies a vital part in the swift achievement of milestones. Process characterization offers a deep understanding of a drug to determine efficient process control schemes and it describes the critical process and product parameters for establishing the proven suitable ranges for cost-effective production.

Even minor changes to a biologic structure at the time of production can lead to a substantial impact on function, efficacy, and safety. Something as straightforward as temperature fluctuation, a variation in pH, a deviation in the process of softening a vial or the shift to a different supplier can have an impact on a biopharmaceutical’s purity and identity. By understanding in advance, the effect of different manufacturing incidents on a biologic and offering data to support these events with process characterization, the threat of production failures and supervisory time delays can be reduced drastically.

Process characterization entails the resolve of suitable ranges for different parameters to safeguard consistency in manufacturing by offering a comprehensive understanding of the process. One method to process characterization analysis is statistical, yet this involves substantial work and can radically lengthen timelines if equipment and expertise are unavailable in-house. Failure-mode and risk-based methods are realistic, but the latter can be constraining as it regards each failure source in isolation, while the former might be faulty if a potential failure mode is excluded.

A platform approach to process characterization will guarantee that the whole process is strong and will lead to an extremely consistent product to expedite efficient BLA filing. The five-step process mentioned below provides complete awareness of the process control and biologic strategies that will speed up the commercial-scale process:

1. Create an outline for a master plan: A comprehensive master plan that illustrates the production and assessment of the biologic from beginning to end, including rationale and strategy for approaches to full-scale validation and small-scale characterization. This will also define the efforts made to execute and accomplish the activities as per current Good Manufacturing Practices (cGMP). The master plan will also ensure a complete and well-thought-out process characterization.

2. Carry out risk assessments: Risk assessments are carried out on product quality and process characteristic traits to create a catalogue of parameters to be assessed at the time of process characterization. Work duplication can be avoided by referring to risk assessments performed for an earlier process characterization plan.

3. Characterize purification and cell culture processes: Monoclonal antibodies are produced by cultured cells in bioreactors. They are later purified and harvested. Process characterization is broken down into the following five activities:

Laboratory scale-down models

Process mapping

Proven Acceptable Range (PAR) studies

In-process sample stability

Impurity clearance

4. Post-characterization risk assessment: Another round of risk assessment is carried out on process parameters built on data from process characterization findings. The result is a listing of non-critical and critical parameters and a ranking of the essential process parameters

5. Process justification report: This report offers a justification of verified acceptable ranges for production parameters and recaps the general control strategy for producing the biologic. It also signifies a foundation for process validation and uses process characterization data. The report draws on past production data.

A comprehensive process characterization process offers a complete awareness of biopharma and the practices under which it can be properly and efficiently produced for potency, purity, and safety. This aids regulatory agency, the biologics company, and finally the patients. On the other hand, process characterization that has been carried out incorrectly can lead to problems with manufacturing performance and regulatory compliance. These can lead to substantial time delays and damaging re-work in the process of getting to the market and can result in tough tolerances for established acceptable ranges, significantly restricting production.

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Facing Challenges Linked to Biologic Drug Formulation

In the near future, the biologics market is expected to witness a sharp growth and is likely to reach a market size of up to US$580.5 billion by 2026. This rapid growth is being ascribed to development in product portfolios, reflected in the large number of biologics being approved by regulatory groups worldwide.

Standing at the forefront in biologics formulation development is the optimization of efficacy and safety while maintaining stability and quality during production. Biologic production exposes the formulation to various conditions and stresses that may give in stability and quality. Not long ago, the need for the creation of intravenous formulations for elevated drug dose like monoclonal antibodies with high protein concentrations has produced further challenges, including degradation.

Today, medicine is experiencing an uprising with recombinant DNA technologies moving from innovative therapies three decades back to the mainstream. The number of biologics getting approval for an orphan indication has gone past 50% in this decade. Also, we are witnessing an evident shift in the pharma industry. Firms earlier seen as ‘small molecule’ have turned their focus towards biologics.

Fresh formulations are designed to decrease viscosity and curtail protein aggregation, leading to the successful production of several biologics. Present challenges emphasize on handling increased concentration and high drug volumes that are driven upstream to drug formulators. Product attributes must also consider patient needs as a dearth of patient conformity will outweigh any new development that drug formulators make.

Formulation Challenges

Drugs formulated poorly can have a major bearing on a formulation development services, and if they advance to the clinical trial stage, drug companies might have to bear the cost of erroneous data sets and wasted resources. This demonstrates why pre-formulation activities and formulation optimization are so crucial to delivering a profitable program.

When it comes to biologics, the tasks linked to the formulation, such as degradation and aggregation, must be considered comprehensively as they can potentially have a serious impact on the safety of patients. If a patient is injected with an aggregated biologic, there is a possibility of induced immunogenicity. As a result, the patient will be uncomfortable, and it will also reduce the medicine’s therapeutic effects. For a cancer patient, a lack of efficiency in treatment could be lethal.

The experience of a patient can be enhanced using delivery device technologies and formulation. Here’s how it can be achieved:

Making use of delivery systems that allow administration of drugs at home thereby circumventing repeated, annoying, and often costly trips to the clinic.

Utilizing greater volume delivery systems to produce a larger volume and cut dosing frequency.

Reduce dosing frequency by formulating drugs to elevated concentrations.

Making self-administered drugs have improved the compliance and treatment of ailment conditions such as diabetes and rheumatoid arthritis, with the underlying shift being led by a sub-cutaneous delivery instead of infusion or IV. This shift to sub-cutaneous delivery is difficult for formulators. How do you offset the drug’s pharmacological requirements with patient’s tolerability?

There are apprehensions around the subcutaneous space and its ability to bear large dose volumes and rapid injection. There are chances of site reaction and tissue disruption occurring and, if the volume is too large and the injection is rapid, there is a possibility of the product to leak from the site of injection, thereby lowering bioavailability.

As curative dose volumes go up into the 2–10 ml space, wearable drug delivery gadgets play a key role in the solution. A wearable gadget permits extended dosing times, without having a negative impact on the patient’s convenience and comfort, and at the same time permits administration at home. The alternatives offered by wearable technology provides new choices that were not possible earlier because of traditionally binding parameters for formulators.

The commercial accomplishment of biologics centres on surmounting the key challenges they present that include being tough for patients to consume, hard to produce, high price with drug administration being a major factor pushing up costs. New and sophisticated drug delivery technologies can sidestep these problems if they are integrated at the early stages of drug development to establish combination products that can influence results positively. Biologics, when blended with patient-centric delivery devices, hold the potential of enhanced outcomes, greater commercial success, and lower cost.

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Understanding Biopharma’s Quality Control and Critical Attributes

As the biopharma sector matures, companies are embracing modern methods to process design, control and development such as automation. However, working with biologics is a lot more complex than it is for small molecules.

Continuous bioprocessing is universally being used among biopharma firms irrespective of whether you have executed complete Integrated Continuous Biomanufacturing (ICB) or not. To enable faster release and enhance product quality, continuous manufacturing is quite helpful and can potentially raise the flexibility, robustness, agility, and efficiency of manufacturing by lowering the number of steps and holds and using smaller facilities and equipment.

Managing Continuous Bioprocessing Through QbD and CQAs

It is important to follow regulatory compliance while manufacturing sustainable drugs on a continuous production setting. Organic therapeutic products like Monoclonal Antibodies (mAbs) are especially complex and have several attributes that can possibly influence the safety and efficacy of the drug. Spotting Critical Quality Attributes (CQAs) for biological medicinal drug products and substances is perhaps the toughest step in the execution of Quality and Design (QbD) for the development and manufacture of biopharmaceuticals.

Key Terms Used in Biologics Quality Control

Some of the key terms as part of the Process Analytical Technology are as follows:

Critical Quality Attribute: Critical Quality Attribute is a microbiological, chemical, physical or biological trait within a suitable distribution, range or limit to ensure the desired product quality.

Critical Process Parameter: CPP is a parameter whose variability influences the CQA and must be controlled to make sure the process achieves the desired quality.

Key Performance Indicator: KPI is a metric for the condition of each step of production. When CPPs continue to be within the defined parameters, the KPIs indicate that each production step progresses accordingly.

Steep Learning Curve of QbD for Biologics

At present, the biopharma sector is facing difficulties that hampered the early enactment of QbD in traditional pharma. Departmentalization muddles the justification of supplementary investment in R&D on the grounds of better return at the time of commercial production. Currently, there is little experience in utilizing QbD to biologics, so the learning curve is steep.

Besides, there are several challenges in applying QbD to biopharma development. A key issue is the heterogeneity and complexity of biopharma products that outstrip their small-molecule equivalents. Also, the science supporting the profitable development and use of biologics is evolving. Both these issues make it hard to strongly identify CQAs and link them safely to CMAs and CPPs and influence technology transfer, which is more complicated with biologics, and less recognized.

Here are some factors that impact the application of QbD in biopharma:

Stability: Stability is a key concern in the biopharma sector, where protein aggregation may weaken the therapeutic effect of a drug and trigger an immunogenic reaction. While drug substances frequently show elevated stability, biologics can be exceptionally sensitive to a certain environment.

Process variability: Biopharma production methods tend to be linked to much greater variability than those applied in traditional pharma. This issue gets more complicated by the lack of proven and valuable process monitoring instruments.

Ease of product characterization: As cells from living beings display greater variability than their smaller molecule chemical equivalents, it can be hard to safely measure the effectiveness of a biologic and to distinguish impurities.

The biopharma industry’s analytical protocols keep evolving to fulfil the need for growing insight, not just for Quality and Design but, for industry advancement. Pinpointing a particular issue as essential will lead to a necessity for trustworthy detection. However, grasping the methods that give rise to a challenge and understanding how to manage the calls for added layers of insight.

With our growing understanding of the basics of biologic behaviour, the need to dig deeper for data to boost additional progress also grows. Conventional, well-established practices, pioneering hybrids and newcomers, all have their unique roles to play in aiding developers and regulators reach a level of understanding and control that will guarantee the continuous innovation of effective and safe products.

Process and product understanding with a strong control strategy and innovation in control technologies and real-time measurement is needed and will be key to the successful execution of quality control tests in the pharmaceutical industry.

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Challenges Involved in Scaling up Drug Substance Development

Preserving a drug’s integrity during pharmaceutical manufacturing scale-up is a challenging task, but it is important for developers who wish to expand their operations to guarantee legal compliance and high standards.

Pharmaceutical firms globally are under immense pressure today to speed up drug substance process development while making it more cost-effective. They are trying their best to ensure that all their drug candidates showing promise hit the market. Bringing drugs to the market as fast as possible is the key to success, but it is also important to address the challenges concerning process development, formulation, stability challenges and scalability. To avoid any late-stage failure, drug companies must follow smart and systematic scientific solutions to eliminate all threats with respect to the drug development process.

As new drugs move from the initial preclinical stages through subsequent phases, the demand for clinical substances is likely to grow enormously. Scaling production is hardly ever uncomplicated, as there are several difficulties such as cost incurred, unforeseen challenges and a lot of time consumption.

When drug development is at its early stages, the drug substance is formed through a synthetic route which may not even be finalized. The drug substance’s physicochemical properties may alter with enhanced synthetic routes or a superior crystallization process, leading to an enhanced impurity profile. However, this is likely to considerably change the behaviour and physicochemical properties of the Active Pharmaceutical Ingredient (API). The problem is quite acute when it comes to products with a higher drug loading and higher dose in formulations.

Processing and formulation experts face several processing and scalability challenges. These challenges can be addressed with no major impact to in vitro release profiles and smart solutions. Any significant change to the drug product process or formulation may necessitate rework.

Early clinical-stage drugs are made on a small scale enough only for a small clinical study and proof-of-concept. Because of the small prerequisite, drugs are produced on semi-automated manual equipment. They are produced on slow-speed gear to have better control over critical process parameters and to preserve materials.

Here’s a look at some of the challenges facing drug firms during scaling up for drug substances and the various factors that are key to the success of a project:

1. Contamination

The biggest worry for drug firms is the danger of product contamination at the time of moving from a small-scale to a large-scale operation. The challenge is quite acute especially when it comes to getting to grips with new processes. To reduce the risk of contamination, the whole pharmaceutical processing system sometimes has to be shutdown.

2. Moving from the milligram method to multi-kilogram process

As contract drug substance development evolves from candidate drug selection to the clinical stages, more drug substance is needed. Therefore, a drug which was earlier produced in milligrams must develop into a multi kg process. This transformation must happen without having any impact on the performance or quality of the API. In other words, there is an escalating demand for larger quality, quantity, and documentation when moving towards market authorization.

Major expertise is needed to flawlessly move products from pre-clinical stage to industrial scale. The synthesis paths used by the chemists are often designed for speed and diversity and to make variants from a known hit substance. In this stage, the primary goal is to optimize and enhance the lead substance for its key activity and the physicochemical properties needed only for dispensing the substance to patients.

3. Cohesivity & Static Charges

New small molecular units in large volumes show high cohesivity and hydrophobicity to the contact surfaces of processing equipment. To boost the surface area of drug substances, active substances are frequently micronized to enhance the solubilization rate. A micronized API frequently show static charges and sticks to container walls and the processing equipment. Adhesion or cohesion to surface parts can lead to unpredictable funnel flow, content uniformity issues and ratholing.

4. Regulatory considerations

It is important to be mindful of regulatory considerations. For instance, prior to scaling up of any US-based production unit, it must adhere to the Scale-up and Post-Approval Changes (SUPAC) sanctioned by the Food and Drug Administration (FDA).

Before scaling up, it is imperative to make sure that all essential steps are performed to reduce timelines and handle any complexities.

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Using Call Center Analytics to Divulge Actionable Insights

In the era of Big Data, to enhance customer experience it is vital for companies to know about the people who are interacting with them. Through call center analytics software you can obtain invaluable actionable information. You will get to know where they are doing well and where they are losing business. Also, it offers information that could potentially boost productivity and sales. Call center solutions give an indication of why customers call, monitor conversions and offer agents real-time analytics.

What Entails Call Center Analytics Software?

Through analytics, you can capture and track all relevant data about people who are calling these centers. You will also gain data such as customer satisfaction, call time length, and the frequency with which a customer calls. It can also use speech analytics tools to obtain a greater awareness of the customer’s frustration. Metrics are subsequently stored in a database within the software for analysis to be carried out later.

How to Get the Most from Speech Analytics

With speech analytics, it is possible for a group of analysts to handle calls in real-time. Businesses can discover inefficiencies in their present model and make necessary upgrades for agents to attain the desired call outcome.

By linking speech analytics software with an AI platform, it is possible to route calls with accuracy. Speech analytics also consider things such as emotion and purpose of the caller. Through this information, it is possible to ensure that customer chats are directed to their preferred agents, who can soothe their nerves or even upsell them, based on what the AI has discovered in their voice.

In addition to cutting costs linked to reviewing, speech analytics also offers an in-depth study of such calls. Instead of recording each call, call center speech analytics tool provides the ability to look at all the data. It is possible to figure out this information manually, but speech analytics accelerates the process and is more accurate.

How Analytics Enhances Customer Service

It is possible to enhance customer experience by looking at data retrieved within call center software. The time customers dedicate for you presents an opportunity for you to grow when it comes to workforce optimization. While having a conversation with the customer, it is important to meticulously thread the needle to guarantee that time is devoted to building trust.

Gamification Using Call Center Analytics Software

It is always a challenge to keep your call center employees involved. By checking analytics and your call logs, you will get to know when it is time to raise team engagement. If there is a drop in conversions or if customers are not getting correct answers and are being compelled to call back more several times, it is time to look for a way to motivate your team.

Through gamification, you can make things fun. With gamification, you will be able to build a sense of getting something extra with a job. It can signify the difference between a pedestrian experience and something folks talk about for days after a call.

Common Approaches to Call Center Analytics

Profitable centers employ sophisticated call center analytics tools to observe and evaluate performance, not just from a customer perspective but also from an employee’s and a business owner’s standpoint. Here’s a list of a few common approaches to analytics:

Text Analytics: With the huge burst in the social media universe, text analytics has a key role to play. It can examine and scrutinize the messages sent to customers and the message they send to the company. This is essential in determining any potential issues through the customer perspective.

Predictive Analytics: The contemporary predictive analysis engine is a key tool in the call center ecosystem. Using a detailed assessment of prior performance in subjects as varied as service level, call volume, customer satisfaction, and handle time, with predictive analysis it is possible to apply past solutions to forthcoming challenges.

Self-Service Analytics: Several companies today are looking for new ways to galvanize self-service outlets. So, they are enabling customers to update their address online on their website, instead of making them call an agent. By doing so, the chances for errors are reduced, thereby lowering company cost and incoming call volume. There may be a few customers who may be unwilling to this change, but many do realize that self-service is hassle-free & efficient.

Cross Channel Analytics: A properly managed call center must have a way to ascertain the channels their customers are using and tailor their services toward that. When an agent has easy access to this information, they can offer customers a more personal interaction. Just like speech analytics, this area is relatively new, but will most probably be a prerequisite in the future.

Customer data is growing rapidly, and acquiring & evaluating that can be a strategic asset as well as an investment for the future.