Assess source and end products in your gene therapy protocols with Covance.  All regulations and recommendations for introduction of genetic material into somatic cells followed by Covance are to the highest standards of quality and safety. Whether your processes involve use of modified adenovirus, retrovirus or other virus vectors, Covance deploys the right analytical tools to provide you with the most rigorous gene therapy evaluations possible.

Covance Biopharmaceutical Services Division provides numerous analytical tools to assess both the source and the end product in your gene therapy program. Our analytical capabilities in protein chemistry and immunochemistry include HPLC, electrophoresis, spectroscopy, mass spectrometry, structure determination, glycoprotein analysis, and assessment of biological activity. Our experience in testing of packaging cell banks and virus seed lots is likewise extensive.

Regulatory guidelines are particularly stringent with regard to the presence of replication competent virus (RCV) in clinical lots. Use the comprehensive Covance testing package to detect RCV presence in vector preparation and have peace of mind you are in compliance with the latest regulatory requirements. Depend on Covance to help you find the most efficient and effective route to clinical studies.

Services:

  • Cell bank and virus seed testing for adventitious agents
  • Replication competent adenovirus (RCA) detection
  • Replication competent retrovirus (RCR) detection
  • Gene Therapy Vector Biodistribution
  • Clinical trial monitoring  (including viral load and vector shedding and distribution)

Biomolecules

Develop, characterize, test and validate with Covance, no matter what technique or molecule you're pursuing. Our experience covers a wide range of biomolecules, including: