Search

Mammalian Stability Studies

All antibody products are tested according to ICH guidelines for Drug Substance & Drug Product, and through forced degradation and pre-formulation studies.
 
As part of the Quality Assurance process, protein products are tested according to ICH guidelines for Drug Substance & Product. These studies help to determine the effect of external factors on the active component within a customer’s product.
The effects of different levels of light, heat, humidity and oxygen levels, as well as a broad range of pH levels, are examined.
 
Forced degradation studies, to accelerate the natural degradation process, are also undertaken to determine the effect on the product.

Other Mammalian Protein Services...

In order to provide complete functionality, this web site needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site. It is recommended that you allow all cookies. Allow all cookies