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Protagen Protein Services (PPS) is a leading provider of contract analytical services in protein science. Long experience of PPS in business and the comprehensive spectrum of validated analytical methods ensure the highest quality to the customers in the pharmaceutical, biotech and life science industry.
PPS provides a strategic approach for characterizing biopharmaceutical products Analysis is performed in a GMP compliant laboratory and fulfills latest regulatory requirements.
State of the art Protein Analytics is provided by PPS for:
- Comparability: Comparability studies should include characterization, physicochemical properties, biological activity, purity, impurities and stability.
- Stability: These studies allow assessing the shelf life of a new drug and also allow studying possible degradation pathways in more detail.
- Release Testing: Products entering the pharmaceutical market require cGMP testing to certify that they are released in accordance with regulatory standards. The analyses should be carried out according sets of guidelines describing the rules to show the product quality.
- Process Development: Determination of critical quality attributes support the development of Up- and Downstream Processing
- GMP/GLP: Good Manufacturing Practice (GMP) is a set of guidelines that outline rules that apply to the production and testing of drugs such as biopharmaceuticals. The main focus of GMP is to ensure the safety of drugs and to set up a rational for the safe release of drugs into the market.
- ICH Q6B: This guidance document ICH Q6B provides a uniform set of internationally accepted specifications for the characterization of biotechnological and biological products to support new marketing applications.
The analysis of biopharmaceuticals is carried out for all biologics that are developed, such as Antibodies, Antibody Drug Conjugates, New Biological Entities and Biosimilars.
Otto-Hahn-Str. 15, 44227 Dortmund, Germany, +49-231-9742-6100