The process characterization of biologics is a key part of the chemistry and manufacturing controls (CMC) section of regulatory filings. In support of “quality by design” for any process, testing of residual process impurities is an integral step.

We have the capabilities to support testing of all process stages for impurities such as residual Protein A, DNA, Tween, endotoxin and host cell proteins.We will provide the development, validation, and support of testing method according to the customer needs.