Stability Studies

Stability studies are an essential means to determine factors that can cause protein aggregation or degradation, which in turn can impact biological activity, product safety and quality. 

We approach drug substance and drug product stability studies using a variety of methods to detect changes in protein structure following forced degradation induced by elevated temperatures, freeze-thawing, mechanical stress, oxidation, and light exposure, plus exposure to the various materials and devices used in drug delivery.  

Forced degradation studies are available to support early stages of development and more comprehensive packages are available to support late phase development.   

Our cGMP compliant stability programs adhere to: 

• ICH guidelines Q1A (R2) “Stability Testing of New Drug Substances and Products” 
• Q5C “Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products” 
• ICH Q6B “Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products” 

Our comprehensive suite of cGMP biopharmaceutical analysis techniques supports the methods required for drug substance and drug product testing during development of Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and New Drug Application (NDA) submissions through BLA/MAA filings and commercial programs.