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Biotechnology Services
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Gene Therapy Products
Scientific progress over the last decade has led to the development of novel methods for the introduction of genetic material into somatic cells, often involving the use of modified adenovirus, retrovirus or other viruses as vectors. Accordingly, regulatory authorities in both Europe and the United States have evolved recommendations with respect to the quality and preclinical and clinical safety of gene therapy protocols.
Our Biotechnology Services Division provides numerous analytical tools to assess both the source and the end product in gene therapy programs. Our analytical capabilities in protein — 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. Covance offers a comprehensive testing package to detect the presence of RCV in your vector preparation. Use our expertise and experience to ensure that your product satisfies the latest regulatory requirements. Depend on us to help you find the most efficient and effective route to clinical studies.
See below for our wide range of testing options for gene therapy products:
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