Maintaining the Stability of Biologics
A number of factors can influence stability, especially with highly-complex biomolecules. The increased risk of instability requires more stringent practices to maintain stability throughout the shelf life of the product. In addition to this, measures need to be taken to minimize exposure to environmental factors that can affect the integrity and efficacy of a product.
Kerry Bradford, analytical projects manager, and Ashleigh Wake, biopharmaceutical services leader, both at Intertek; Kim Cheung, senior director of quality at Genzyme; and Niall Dinwoodie, global coordinator of analytical testing, biologics testing solutions at Charles River, spoke with BioPharm International about the challenges in maintaining a stable environment for biologics, how to determine shelf life, the effects of upstream processing techniques on the end product, and biologics versus small-molecule drugs and the importance of stability testing.