Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products Course "Efficient Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products" has been preapproved by RAPS as eligible for up to 1.5 credits towards a
participant's RAC recertification upon full completion.
Date & Time:
Tuesday, June 26, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Jeff Schwegman
Price : $245.00
Jeff Schwegman Founder and CEO, AB BioTechnologies LLC
(for one participant)
Overview: Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on developmentscale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers. Without understanding the scientific principles behind scale-up and cycle transfer, many companies will try tweaking the cycle parameters when problems are encountered during scale-up. While this approach may work occasionally, often, it will lead to additional problems such as excessively long cycle times, shattered vials, higher residual moisture content, etc. Taking the time to design and execute a well thought out scale up study, will ensure that cycles and products will transfer seamlessly from dryer to dryer without costly time delays and product rejection. One issue in particular that has been observed during scale-up, is loss of vacuum control within the product chamber of the freeze-dryer. Common sense would dictate a vacuum pump failure or a vaccumleak as the source of failure; however, the phenomenon known as, "choked flow", is something completely unrelated to vacuum pumps and vacuum leaks. Being able to identify the difference between vacuum system issues and choked flow makes correcting the problem much easier, saving both time and money in diagnosing and correcting the problem.
Why Should You Attend:
Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com) where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral preformulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization. ...more
Many problems have arisen in the past when designing and scalingup lyophilization cycles because this process was more of an art than Suggest a Topic More Webinars a science, and cycles were designed and scaled-up based on a "trial and error" approach. Companies that do not understand the Your Necessity is our Priority scientific principles behind their cycles run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin. By far, one of the most difficult tasks in getting a lyophilized product from the laboratory bench to the commercial freeze-dryer is scale-up, or cycle transfer. Problems that typically arise from scale up issues include shattered vials, meltback, collapse, higher residual moisture levels, and decreased shelf life. By taking the time to identify the critical issues for a particular product and understanding equipment differences, the development scientist or engineer has a much higher chance of successfully producing consistent, quality, product whether it is being dried in a development-scale dryer, a clinical-scale dryer, or a large commercial-scale dryer.
Areas Covered in the Session:
Critical parameters in scale-up and cycle transfer Scale-up strategy Mapping studies Dryer configuration
Determining and preventing choked flow conditions
l l l
Click here to register for this webinar Learning objectives: l
Understanding the differences between development, pilot, and productions dryers
Proper information gathering (IO, OQ, manufacturer specifications, operator knowledge, etc.)
Design and execution of a well thought out scale up strategy Identifying choked flow conditions, and designing a cycle to
prevent choked flow from occurring
Who Will Benefit: This webinar will provide valuable assistance to those companies involved in the development and scale-up of therapeutic and diagnostic lyophilized products. l l l l
Quality Control Scientists Development Scientists Production Management Quality Assurance
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Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing....