Objective:
Typically, a "trial and error" approach is used to develop lyophilized products; however, within the past 15 years, new tools and technologies have become available which allows development scientists to take a more scientific, empirical approach to formulation and cycle design. Using these approaches, scientists can design a formulation and optimized drying cycle specifically tailored for each product, which maximizes stability, and minimizes the pre-formulation, formulation, and cycle development processes.

Specific focus will paid to the biologically based products (globular proteins, monoclonal antibodies, etc.), as these types of therapeutic molecules are coming to represent a larger part of the injectable drug market, and require additional care in development due to the instabilities in the physical structure of these types of molecules. Additionally, 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.

This workshop is intended to provide guidance and insight in the development of sound formulations and optimized drying processes for lyophilized parenteral drug products.

About the Symposium Leader:
J. Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com), which specializes in thermal characterization, parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He is also currently the Course Director for the Center for Professional Innovation and Education where he teaches the Lyophilization Technology course in the United States and at various locations in Europe. In addition, he holds several patents and develops new technologies in lyophilization science.

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 of parenteral products. 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 Ph.D. 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.