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2. Process evaluation for biopharmaceuticals: what is appropriate in process evaluation? Lubiniecki AS, McAllister PR, Smith TM, Shadle PJ. Dev Biol Stand; 1996; 88():309-15. PubMed ID: 9119154 [No Abstract] [Full Text] [Related]
3. Relationship between nature and source of risk and process validation. Berthold W, Werz W, Walter JK. Dev Biol Stand; 1996; 88():59-71. PubMed ID: 9119164 [No Abstract] [Full Text] [Related]
4. Issues related to harmonization of testing requirements for viral safety. Hayakawa T. Dev Biol Stand; 1996; 88():15-8. PubMed ID: 9119129 [Abstract] [Full Text] [Related]
6. Safety of biological products prepared from mammalian cell culture. In-process testing for viral agents. Dev Biol Stand; 1998; 93():130-1. PubMed ID: 9737389 [No Abstract] [Full Text] [Related]
7. Biologicals: an attempt at classification and its implication for the viral safety of products. Horaud F. Dev Biol Stand; 1993; 81():17-24. PubMed ID: 8174800 [No Abstract] [Full Text] [Related]
8. Strategies for the validation of viral inactivation in biologic products. Aronson DL. Prog Clin Biol Res; 1990; 324():137-49. PubMed ID: 2408050 [No Abstract] [Full Text] [Related]
9. Safety of biological products prepared from mammalian cell culture. DNA. Dev Biol Stand; 1998; 93():136-8. PubMed ID: 9737393 [No Abstract] [Full Text] [Related]
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14. Biosafety and product release testing issues relevant to replication-competent oncolytic viruses. Wisher M. Cancer Gene Ther; 2002 Dec; 9(12):1056-61. PubMed ID: 12522444 [Abstract] [Full Text] [Related]
15. Viral safety of biological products in WHO policy. Grachev VP. Dev Biol Stand; 1991 Dec; 75():241-6. PubMed ID: 1794628 [Abstract] [Full Text] [Related]
16. Validation of virus removal in large scale purification processes. Fritsch E. Dev Biol Stand; 1992 Dec; 76():239-48. PubMed ID: 1478342 [No Abstract] [Full Text] [Related]
17. Validation of purification procedures for removing and/or inactivating viruses in biologicals: points to consider. Vicari G. Dev Biol Stand; 1991 Dec; 75():227-32. PubMed ID: 1794625 [Abstract] [Full Text] [Related]
18. Theoretical considerations on viral inactivation or elimination. Willkommen H, Löwer J. Dev Biol Stand; 1993 Dec; 81():109-16. PubMed ID: 8174793 [No Abstract] [Full Text] [Related]
19. Safety of biological products prepared from mammalian cell culture. Detecting viruses in cell banks. Dev Biol Stand; 1998 Dec; 93():129. PubMed ID: 9737388 [No Abstract] [Full Text] [Related]
20. Considerations in performing virus spiking experiments and process validation studies. Darling AJ. Dev Biol Stand; 1993 Dec; 81():221-9. PubMed ID: 8174806 [Abstract] [Full Text] [Related] Page: [Next] [New Search]