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April 15, 2010 (Vol. 30, No. 8)

Viral Safety Methods for Manufacturing

Designing Proper Procedures to Protect Both Potential Patients and Cell-Line Production

  • The growing significance of biotherapeutics, particularly monoclonal antibodies (mAbs), assures that increased demand for virus-safety products and services will continue, despite the trend toward a more risk-based approach to virus removal and inactivation. Virus safety is one component of world-wide regulatory guidelines requiring biomanufacturers to demonstrate that their ...

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