mAb Stability Program
Are you confident in your drug’s ability to withstand various uncontrollable environmental factors? Get answers with our stability testing solutions for product development. Our program will demonstrate the short- and long-term stability of a biologic after exposure to various environmental conditions, such as temperature, humidity, light, freeze/thaw cycles, and container/closure interactions.
Successfully Release your Product to Market
Integrated within a standard stability package is an accelerated stability program designed to gain quick insights into your drug’s expiration date by subjecting your product to an elevated level of stress. Successfully completing this accelerated program allows you to release your product to market. All stability studies are conducted in a GMP environment, and all assays are performed to meet ICH guidelines; assays qualified as GMP when required.
mAb Stability Assays, Conditions, and Timepoints
Our multi-year stability program includes the following assays performed at a range of ICH stability conditions: