BIOT 104 |
| Biopharmaceutical products manufactured from mammalian cells must demonstrate that they are safe and free of endogenous retroviruses. Regulators require at least two orthogonal methods of clearing these retrovirus particles, whether it be physically removed or inactivated as part of the manufacturing process. The virus filter functions as a physical barrier to putative retroviruses while allowing the antibody product to flow through. Development of the virus filtration step for the production of a monoclonal antibody was carried out at small scale to define operating parameters in manufacturing. Parameters examined included flow rate, concentration, temperature and the use of a guard filter. Scale-up of the virus filtration step from lab-scale to pilot scale to manufacturing scale will be discussed. |
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Downstream Processing: Bioprocess Integration & Industrial Case-Studies
3:00 PM-5:20 PM, Monday, August 20, 2007 BCEC -- 107 A/B, Oral
Division of Biochemical Technology |