Supporting the testing, development and manufacturing of BioPharmaceuticals

The ICH Q5 quality guidelines provide guidance on the assurance of Quality of Biotechnological Products or BioPharmaceuticals. Advances in biotechnology are revolutionizing the research and development of new medicines which are developed not by synthetic methods but instead are being derived from biological sources, usually involving live organisms or cell lines. New products require new mechanisms for analyzing and qualifying the characteristics of these medicines.

As a leading provider of molecular genetic services combined with our 30 year history in pharmaceutical testing we offer:

• Protein and Analytical Chemistry
• Cell line Characterisation
  • Identity
  • Purity
  • Construct Analysis
• Genomic Services
  • Residual DNA analysis
  • Viral nucleic acid detection
  • Copy number analysis
  • Restriction enzyme analysis
  • qPCR
• Stability Testing
• Lot and final drug product testing

We offer a comprehensive range of stand alone or integrated packages of services tailored to meet your specific needs for biologics testing.

For further information on our Global service offering please email pharmaservices@gen-probe.com