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Recombinant Proteins
With the current rapid growth in development of protein and polypeptide-based therapeutics produced by recombinant DNA technology, it is critical that such products be well characterized in order to move them successfully to the marketplace. It is also critical to test the raw materials and cell banks used in the production of recombinant proteins for viruses, retroviruses and other adventitious agents, as well as to monitor the bulk harvest of the product. The purification process must also be evaluated for its ability to clear virus. Finally, assessment of stability and safe, reliable storage are of paramount importance in ensuring the security of the product throughout its development and commercial production.

Covance Biotechnology Services have extensive experience with a wide range of proteins, from various common expression systems through to less common vectors such as baculovirus. Our analytical capabilities in protein- and immunochemistry include HPLC, electrophoresis, spectroscopy, mass spectrometry to aid in structure determination (primary, secondary and tertiary), glycoprotein analysis, and assessment of purity and stability. Our experience in determination of biological potency is likewise extensive.

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