Therapeutic agents require testing for stability. Documenting the stability of the drug substance or drug product in different storage conditions is essential for setting specifications for expiry and shelf life. Understanding the possible pathways where degradation may occur is crucial to designing an appropriate stability program. Developing and validating stability indicating methods that assess possible pathways of degradation is important for the success of any stability program. Implementing a program on schedule will prevent use of less potent material by setting adequate expiration dates supported by stability data.
Small molecule pharmaceutical products require expiry dating. Data supporting expiry dating controls how long these products should remain on the shelf. Testing for specific environments ensures product stability during regional shipments. To collect data that supports expiry dating drug substance and drug product must be thoroughly tested in stability indicating methods. Understanding the importance of these methods and the analysis and use of the data is necessary for personnel involved in product development, product testing, and product release.
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.