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Virus Studies
- Note for Guidance on Virus Validation Studies, The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses CPMP/BWP/268/95
- Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Q5A(R1)
- Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products EMEA/CHMP/BWP/398498/2005
- Guideline on plasma-derived medicinal products EMA/CHMP/BWP/706271/2010
- Guideline on Similar Biological Medicinal Products CHMP/437/04
- Guideline on the use of Porcine Trypsin used in the manufacture of human biological medicinal products.
- Use of bovine serum in the manufacture of human biological medicinal product
TSE Studies
- Position Statement on Creutzfeldt-Jakob Disease and Plasma Derived and Urine Derived Medicinal Products
- Guideline on the Investigation of Manufacturing Processes for Plasma-Derived Medicinal Products with Regard to VCJD Risk
- Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Enchaplopathy Agents via Medicinal Products
FDA
- Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
- Points to Consider in the Characterization of Cell lines used to produce biologicals
- Characterization and Qualification of Cell Substrates and other Biological Materials used in the Production of Viral Vaccines for Infectious Disease Indications
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