Protagen Protein Services (PPS) is a leading global analytical CRO and a recognized expert for analytical and CMC services in protein science for biologics.
The company is an industry-leading partner for the biopharmaceutical industry worldwide and offers the most advanced, integrated and complete analytical service and mass spectrometry capabilities in biopharmaceutical development, from clone selection through drug approval to commercialization.
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.
CDMO for Biologics
PPS provides integrated end-to-end solutions within CDMO (Contract Development & Manufacturing Organization) outsourcing services. As CDMO PPS helps pharmaceutical and biopharmaceutical companies move rapidly from research stage of their drug development to clinical stages with integrated services to compress timelines to market.
Formulation screening and development, analytical development, stability studies and release testing, IND/IMPD and NDA/CTD services, and the full range of GMP services: PPS delivers comprehensive high-quality CDMO solutions for biologics, customized for complex products and unique production processes, to streamline the development and manufacturing of a variety of biologics.
Disposing of three state-of-the-art sites in the US and Europe and relying on global regulatory expertise, PPS specializes in the development of innovative biopharmaceuticals.
Choose PPS as CDMO to help you:
- Support our clients to move rapidly through the drug development value chain
- Perform complex formulation screening and development
- Accelerate process development under GMP or non-GMP compliance
- Ensure regulatory compliance throughout each stage of the development cycle with full CMC-RA support
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 revolutionised 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:
- Identifying the major protein component
- Identifying the minor components
- Quantifying 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: