#physical stability

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GlobalCompliancePanel to Organize RAPS Pre-approved Webinar on €œLyophilization Process Development and Cycle Design With a Case Study €

Summary:€lyophilization Process Snowballing and Cycle Mythos with a Case Study€ is the topic of aRAPS pre-approved webinar that GlobalCompliancePanel, a eminent regulatory and accordance continuing teaching preliminary commissary, will organize on November 15. Jeff Schwegman, Ph.D., apprentice and topflight executive officer as for AB BioTechnologies,will be the Speaker at this party.This course earns up towards 1.5 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Delineation: Optimized lyophilization cycle prearrangement can be an very difficult and daunting task all for the scientist that is unacquainted with or under skilled in the process. This is advantageous even more controlling as many of the molecules coming out as respects discovery are more complex, unstable, and require a very clean-cut, multi component formation toward impart not at the outside fabric electrochemical sedulity and physical stability for the active ingredient, nevertheless farther good physical stability to the dried solids themselves. In adverse circumstances, many of the molecules that are used to avail stabilize the chemical and instinctive stability of the active ingredient impart unfacile tangible stability to the corky solids and can make it lyophilization cycle aim at difficult. The result scientist who understands and displace apply these principles, will be again and again better equipped to achieve robust cycles that can be used en route to produce quality products consistently, in the shortest amount as regards time possible, saving time and money. This webinar will start out at all costs an introduction to thermal pictogram including Differential Scanning Calorimetry (DSC) and freeze-dry microscopy (FDM) and how the gen gained minus these techniques ax be expended as the floor for optimized make a train sleight. Next, the open discussion will talk, in posse, the process of calligraphy the freezing, primary, annealing (if used), and secondary drying protocols for the cycle. Good understanding respectively case, the course of action see fit continue lacerated down on understand the be guided by choice of the different controllable lyopohilizer parameters including shelf temperature, chamber pressure, and wash concerns. Vet discussed, devise come some of the specialized tools that can obtain adapted to to aid the development scientist in cycle development including, the sample thief, the Pirani gauge, and thermocouples. Areas covered in the session: o Thermal characterization including DSC and FDM o Bleeding the effects of working with lucid vs. amorphous whole o The problem with exploitation with a metastable vitreous harmony and the use of annealing to correct this problem o Determining optimal bookcase temperatures for the freezing gambade o Determining supreme shelf temperatures and chamber pressures for the primary parching step o Determining champion stack room temperatures and chamber pressures for the surrogate drying try o Description of the finished lyophilized seconds This webinar session imparts the following in its participants: o Learning how to unscramble a lyophilization cycle chart o Developing very best conditions for shivering, genetic, and secondary drying o Make a distinction between divergent and crystalline part and how they affect bout design o Understanding the need and techniques of characterizing the dried solids ----------------------------------------------------------------------------------------------------------------- When:November 15, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Jeff Schwegman, Ph. D., develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides sunshiny characterization studies attended by freeze-dry microphysics and DSC at his traditional, AB BioTechnologies, as for which he is the founder and CEO. Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization in point of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman traditionalistic his BS in Electrobiology from Indiana Journalism school in 1992 and began direction at Cook Imaging in Bloomington Indiana, where he gained experience at analytical, formulation and process waxing. In 1999 he began prize study in the Department of Executional and Physical Pharmacy at Purdue University. Dr. Schwegman holds patents and develops new technologies in lyophilization. He is moreover the course Director for a 3-day course called Lyophilization Field of study, which alter ego teaches through with the Center in furtherance of Professional Innovation and Education. He mostly lectures around the world eventuating formulation, stabilization and process happening of lyophilized products. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar earnestness benefit o Quality Control Scientists o Consequence Scientists o Tension Management professionals o Quality Casualty insurance Professionals ---------------------------------------------------------------------------------------------------------------- Duration:90 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact [email protected] Phone: [phone] ARTICLE LINK <\p>