On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies.
Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Data integrity, Formulation, Good Manufacturing Practice (GMP), Informatics, Ingredients, Manufacturing, Microscopy, QA/QC, Regulation & Legislation, Research & Development (R&D), Supply Chain