This webinar will cover formulation and process development strategies for stabilizing biologically based pharmaceutical and diagnostic products including proteins, cells, and viruses (live, modified live, attenuated). Understanding the degradation mechanisms and improving stability of these molecules through formulation and processing techniques will be discussed in great detail in addition to covering some of the analytical techniques employed to verify the results.
Areas Covered in the Session:
Thermal properties of formulated products
Mechanisms of degradation (chemical and physical)
Theory of physical stabilization of biologically based products
Process of choosing the best stabilization agents to use and their effects on the thermal properties
Analytical techniques used to develop and verify acceptable formulations and processes
Why should you attend:
Within the last 10 years, the amount of biologically based pharmaceutical and diagnostic products (proteins, peptides, viruses (live, modified, attenuated), and cells has grown substantially. This has been due largely to solving the human genome, and understanding the genetic make-up and function of biologically based and genetic disease agents. Unlike small molecules, these types of molecules are extremely complex both in their structure, in their function, and in their mechanisms of action. Since these molecules are biologically based, and derived from living organisms (or at least containing genetic material in the cases of viruses), they pose a real challenge for the formulation and process development scientist who is trying to take these entities from their stable environment in the body, and place them in vials, tubes, etc. for long term storage, so that they can be used later for parenteral administration, or for use in diagnostic kits. Developing a formulation and manufacturing process to keep these molecules stable is a very difficult task, and many factors have to be taken into consideration to protect these labile molecules. As such the resulting formulations for these products tend to be very complex, and many of the excipients used to help stabilize these products for a short period of time in the liquid state, make it extremely difficult or impossible to freeze-dry them with any success either in retaining physical structure or activity, titer, viability, etc. Understanding the routes of degradation and the mechanisms of stabilization, make it much easier to develop a safe, effective product with a long shelf life.
This webinar will start off with a discussion of the thermal properties of a formulated product and how stabilizing excipients can affect these (the first step in any well designed and understood process and formulation). Next, the discussion will turn towards understanding the different types of biologically based products commonly encountered in modern pharmaceutical and diagnostic markets, and the problems with long term stability. The mechanisms and process of stabilization through targeted stabilizing excipients and lyophilization will be covered in great detail, in addition to understanding the analytical techniques used to develop and verify a suitable formulation and process. Finally, the session will finish with a discussion on formulation and stabilization techniques for cells and viruses, which pose a very large challenge for the formulation and process development scientist.
Who will benefit: (Titles)
This webinar will provide valuable assistance to those companies involved in the development and manufacture of liquid and lyophilized proteins, peptides, monoclonal antibodies, cells, and viruses.
Quality Control Scientists
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 3-day course called Lyophilization Technology which he teaches through the Center for Professional Innovation and Education. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.
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