This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.
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, melt back, collapse, higher residual moisture levels, and decreased shelf life.
This webinar will help you identify the critical scale-up issues for your lyophilized product and understand equipment differences. You will learn how to use this knowledge to successfully produce a consistent, quality, product whether it is being dried in a development-scale dryer, a clinical-scale dryer, or a large commercial-scale dryer. The presenter will also discuss the phenomenon known as sonic water vapor flow or, “choked flow” in a freeze-dryer. This is a problem that typically manifests itself when scaling-up a lyophilization cycle or transferring that cycle to another freeze-dryer, and is characterized by a loss of control over the vacuum in the sample chamber. This webinar will cover the reasons for choked flow, how to recognize choked flow is occurring, and how to prevent this from happening in future cycles.
Areas Covered in the Webinar:This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods. Personnel who will benefit include:
Jeff SchwegmanFounder and CEO, AB BioTechnologies LLC
J. 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 pre-formulation, 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.
Dr. Schwegman received his PhD from Purdue University in 2003 and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 4-day course called “Lyophilization Technology, a Hands-On Approach”, which he teaches through SP Scientific. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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