Contract Manufacturing of Biopharmaceutical Grade Antibodies
The success of over a dozen approved human antibodies on the therapeutic market supports the mature status of pharma-grade antibodies as group of biopharmaceuticals. With a significant higher number in clinical trials and the search for new recombinant proteins as a result of the human genome sequencing program it is expected that many more human antibodies will enter the market in years to come (Gura, 2002, Walsh, 2000).
KeywordsBiomass Fermentation Filtration Carbohydrate DMSO
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- Adair, F. Ozanne, D., 2002, The immunogenicity of therapeutic proteins. BioPharm 15(2): 30–36.Google Scholar
- Clayton, T., Jenkins, I., Steward, P., 1999, The improvement of aeration in 8000L animal cell culture vessels. In Animal Cell Technology: Products from Cells, Cells as Products (A. Bernard et al. eds.), Kluwer Academic Publ, p p.277–283.Google Scholar
- Iyer, H., Henderson, F., Cunningham, E., Webb, J., Hanson, J., Bork, C. and Conley, L., 2002, Considerations during development of a Protein A-based Antibody Purification Process. BioPharm 15(1): 14–53.Google Scholar
- Moran, E., McGowan, S.T., McGuire, J.M., Frankland, J.E., Oyebade, I.A., Waller, W., Archer, L.C., Morris, L.O., Pandya, J., Nathan, S.R., Smith, L., Cadette M.L., and Michalowski, J.T., 2000, A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma. Biotechnology & Bioengeneering 69: 242–255.CrossRefGoogle Scholar
- Rathore, A., and Velayudhan, A., 2003, Guidelines for Optimization and Scale-Up in preparative chromatography. BioPharm 16(1): 34–42.Google Scholar
- Sofer, G., 2003, Virus Inactivation in the 1990s-Part 4, culture media, biotechnology products, and vaccines. BioPharm 16(1): 50–57.Google Scholar
- The Biopharmaceutical Process Extractables Core Team, 2002, Evaluation of Extractables from Product-Contact Surfaces. BioPharm 15(12): 22–34.Google Scholar
- Warner, T.N., and Nochumson, S., 2003, Rethinking the economics of chromatography. BioPharm 16(1): 58–60.Google Scholar