Millipore Technical Publications |
 | AN- AN1650EN00 | |
Ensuring Regulatory Compliance: Validation of Virus Filtration | ||
| Lit No: | AN1650EN00 | |
| Year: | 2002 | |
| Biological therapeutics of recombinant and plasma origin are commonly manufactured using biological source material that is intrinsically contaminated with viruses. Moreover, some manufacturing processes are, by their nature, susceptible to virus contamination from extrinsic sources. Accordingly, manufacturers of biological drug products are required to incorporate sufficient virus clearance steps into their manufacturing processes to ensure that their products are virus contaminant-free. Spiking studies are designed to validate the effectiveness of each virus clearance step. This brief highlights many of the key study design considerations and the basic elements of a well-designed virus filtration spiking study. It is intended to serve as an aid for spiking study sponsors to design and execute a successful spiking study and to remain in compliance with current regulatory requirements. Click the PDF above for the full document. | |
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