Viral clearance process evaluation
by MDS Pharma Services
This white paper by MDS Pharma Services describes the process and complications involved in viral clearance process evaluation. The qualification process includes biosafety testing for microbial contaminants, identity testing and the characterization of a cell bank’s cellular production system—DNA sequence analysis and genetic stability. Manufacturers are expected to implement processes that are designed based literally on the notion of “overkill.” The clients generally come to their dedicated facility, set up their process, and conduct the viral clearance study. All viruses are obtained from certified sources, produced and assayed according to good manufacturing practices (GMPs).
| Published: | 2004 |
| Format: | |
| Length: | 5 pages |
| Type: | White paper |
| Language: | English |
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