Protagen Protein Services (PPS) is a world leading CRO and a recognized expert in mass spectrometry methods for analytical and CMC services in protein science for biologics. Over 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry. PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity. For developing new biological entities (NBEs) PPS supports customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.

Our services as CRO

Based on unique CRO partnerships with our clients, dedicated PPS teams generate best-in-class analytical data packages for proteins. Cooperating with the company‘s pharmaceutical partners as their CRO, PPS provides scientific, technical and regulatory CMC services to advance, de-risk and accelerate all stages of biopharmaceutical development including biosimilar development at highest quality from clone to clinic.

Biologics Full Service

To provide full service in the field of biologics, PPS offers an all-encompassing range of analytical capabilities from drug discovery and development to release testing and regulatory CMC Services under ICH Q6B.

Biologics have revolutionized the treatment and prevention of many disabling and life-threatening diseases. These drugs are mostly derived from biological sources such as animal cells, bacterium and yeast. Biopharmaceutcial drugs can either be small molecules such as human insulin, erythropoietin (EPO), human growth hormone G-CSF or complex large molecules such as monoclonal antibodies.

As proteins are complex molecular entities derived from biological processes, they are almost always not fully purified and homogeneous molecules, but instead show a certain degree of structural heterogeneity. This means that the characterization of a protein always has three aspects:

  • Identification of the major protein component
  • Identification of the minor components
  • Quantification of the minor components (both process- and product-related impurities)

Furthermore, analysis of a protein is not complete without characterizing its functional integrity.

To provide this biologics full service PPS offers the full range of capabilities, from drug discovery and development to release testing and regulatory CMC Services under ICH Q6B.

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Our biologics full service covers analytical capabilities and mass spectrometry expertise for: