ProtaGene ProtaGene

Inselwiesenstrasse 10

+49 7131 74 50 40



ProtaGene is a world-leading CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and complete protein and gene analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021, GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were added to our portfolio, establishing ProtaGene.


With 25 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. ProtaGene supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity. For developing new biological entities (NBEs) ProtaGene supports customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.

ProtaGene genomics capabilities for gene therapy trials provide best-in-class molecular  analysis services and long-term follow-up to ensure the safety of novel cell and gene therapies focusing on insertional mutagenesis and genotoxicity. Highly sensitive platforms and bioinformatics tools determine fusion sequences adjacent to known DNA or RNA fragments in minimal tissue samples down to the single cell level. Applications include clonality and safety of (viral) vectors in gene therapy, on-target specificity of designer nucleases, immune repertoire studies in T cells and B cells and next generation sequencing (NGS). Based on our unique worldwide experience in gene therapy studies, bioinformatics, NGS, and associated regulatory demands we help our customers by designing solutions entirely tailored to their needs.


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.

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