Release Testing

Protagen Protein Services (PPS) provides release testing for our customers since many years including a broad and steadily increasing number of available methods including also mass spectrometry. After GMP method validation release testing with fixed specifications on e.g. identity, content, purity, impurity or activity is performed with quick turn-around times. We provide release testing for the EU, US and other regulatory markets.

PPS has long-standing experienced in:

• Developing and validating state-of-the-art analytical methods for release testing
• Transferring release methods to clients site
• Working with client supplied methods, literature or pharmacopoeia methods

Release testing encompasses a variety of previously validated studies to demonstrate product compliance and to ensure consistency in product activity, identity and purity. It is a crucial step in the release of the final product to the market.

Typical release tests are detailed in the table below.