Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product

Why Should You Attend:

The Food and Drug Administration (FDA) is becoming more and more educated in the practice and science of lyophilization. As such, they are asking more questions about lyophilization during NDA or ANDA document reviews, site visits to companies producing lyophilized products, etc. It is now expected by the FDA, that companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added to a formulation, why they are using as much as they have added, what are the critical temperatures of the products (glass transition temperature, Tg’ or eutectic melting temperature, Te), etc. Companies that cannot produce this type of information 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.

The topics described in this session will cover all of the aspects of understanding the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used to develop a stable, optimized, cGMP compliant product. At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them. By understanding and applying these principles, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the “trial and error” approach to formulation and lyophilization cycle design.

Areas Covered in the Webinar:

• Pre-formulation assessment
• Selecting acceptable formulation components
• Buffers and buffer capacity
• Antioxidants, stabilizers, surfactants, bulking agents, complexing agents, cosolvents
• Crystalline vs. amorphous vs. mixed systems
• Eutectic melting, glass transition, and collapse temperatures
• Thermal characterization techniques
• Filling and fill volume
• Biomolecule stabilization theory
• Excipient considerations
• Infrared analysis of proteins

Who Will Benefit:

This webinar will provide valuable assistance to those companies involved developing formulations and lyophilization cycles, or in lyophilization product manufacturing. Those who would benefit from this webinar include:

• Quality Control Scientists
• Development Scientists
• Production Management
• Quality Assurance

Jeff Schwegman
Founder 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.

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