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The Center for Professional Advancement, 90 Minute Accredited Online Training
February 3, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is designed for personnel in the pharmaceutical, diagnostic, biomedical engineering and biotechnology industries including:
• Biochemists/Chemists
• Pharmacists
• Production Supervisors
• Chemical Engineers
• R&D personnel
• QA/QC professionals
• Microbiologists
• Pilot Plant Operations
• Managers
Description
This 90-minute accredited online course is designed to provide an introduction to the basic scientific principles of conducting scale-up and cycle transfer studies for freeze-dried products, in addition to understanding the causes and prevention of sonic water vapor flow (choked flow) within external condenser freeze-dryers. This course will provide insight into scaling-up a lyophilization cycle from development to production scale, transferring a lyophilization cycle to different freeze-dryers, and determining if the lyophilization cycle of interest will force the freeze-dryer into choked flow conditions resulting in failed batches.
Module 1: Scale-Up
• Critical Parameters in Scale-Up
• Developing a Scale-Up Strategy
• Temperature Mapping Studies
• Development Scale and Production
Scale Equipment Limitations
Module 2: Cycle Transfer
• Critical Parameters in Cycle Transfer
• Developing a Cycle Transfer Strategy
• Dryer Configuration
Module 3: Sonic Water Vapor Flow
• Defining Sonic Water Vapor Flow (Choked Flow) in a
Freeze-Dryer
• Conditions Resulting in Forcing a Freeze-Dryer
into Choked Flow
• Equipment Design Characteristics to Minimize
Choked Flow
• Determining the Conditions for Choking Your Freeze-Dryer
• Case Study in Choking a Freeze-Dryer
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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J. Jeff Schwegman Ph.D., Founder/CEO AB BioTechnologies
J. Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies where he 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 routinely lectures around the world on formulation, stabilization and process development of lyophilized products. He has also been an active member of AAPS since 2001.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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