Preparation of Clinical Trial Supplies of Biopharmaceuticals
For most monoclonal antibodies (MAbs), preparation of research supplies is relatively straightforward. Cell culture is done by brute force, since little time is available to optimize product gene expression or cell growth. Systems that are often employed include: 1) suspension culture in spinner vessels, roller bottles or other containers, 2) ascites production in mice, and 3) hollow-fiber bioreactors.
KeywordsSuspension Culture Load Ratio Hydrophobic Interaction Chromatography Purification Cost Clinical Supply
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- Center for Biologies Evaluation and Research (1994) Draft points to consider in the manufacturer and testing of monoclonal antibody products for human use. Rock ville, MDGoogle Scholar
- Center for Biologies Evaluation and Research (1997) Points to consider in the manufacture and testing of monoclonal antibody products for human use. Rockville, MDGoogle Scholar
- Committee on Proprietary Medical Products (1991) Note for guidance: Validation of virus removal and inactivation procedures. BrusselsGoogle Scholar
- Food and Drug Administration (1987) Guideline on validation of the Limulus amebocyte lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. Rockville, MDGoogle Scholar
- Horaud F (1991) Introductory remarks: Viral safety of biologicals. Develop Biol Standard 75: 3 – 7Google Scholar
- International Conferences on Harmonization (1997) Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. GenevaGoogle Scholar
- Lubiniecki AS (1998) Process validation. Develop Biol Standard in pressGoogle Scholar
- Lubiniecki AS, May LH (1985) Cell bank characterization for recombinant DNA mammalian cell lines. Develop Biol Standard 60:141–146Google Scholar
- Lubiniecki AS, McAllister PR, Smith TM, Shadle PJ (1996) Process evaluation for biopharmaceuticals: What is appropriate in process evaluation? Develop Biol Standard 88: 309 – 315Google Scholar
- McAllister PR, Shadle PJ, Smith TM, Scott RG, Lubiniecki AS (1996) Use of a statistical strategy to evaluate sources of variability in viral safety experiments for a recombinant biopharmaceutical. Develop Biol Standard 88: 111 – 121Google Scholar
- Shadle PJ, Erickson JC, Scott RG, Smith TM (1995) Antibody Purification. US Patent # 5,429, 756Google Scholar
- World Health Organization Study Group (1987) Biologicals. Develop Biol Standard 68: 69 – 72Google Scholar