Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval

Stability studies for active pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of the stability program are (1) to determine an appropriate and safe stability profile during clinical development and (2) to justify a shelf-life for the product to enter the market.

The approach to stability testing and interpretation of stability data has undergone significant change. Strategic international ICH regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including both chemical drugs and biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).

Therefore, it is most important for a pharmaceutical company to have an effective and regulatory compliant stability program strategy that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary from the stability program to be successful in getting the chemical drug/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?' Regulatory compliant deficiencies in stability program have resulted in clinical holds and market approval delays.

This course will help the attendee to design and implement a stability program meeting global stability requirements and expectations. Participants will also become effective in interpretation of stability data.

John Geigert, Ph.D., RAC, is President of BioPharmaceutical Quality Solutions, which for the last 12 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.

Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development for Cetus Corporation in Emeryville, CA. At these companies, he led the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products (4 recombinant proteins and 2 monoclonal antibodies) now commercially available in the U.S. and Europe.

He has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board, and served as an expert member of the USP Biotechnology Committee.

He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.