1. ICH. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1999.
2. CHMP. Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products. European Medicines Agency 2008.
3. CPMP. Note for Guidance on Virus Validation Studies: the Design Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. European Medicines Agency 1996.
4. FDA.Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. Food and Drug Administration 1997.
5. PDA.Preparation of Virus Spikes Used for Virus Clearance Studies. Technical report;2010:47.