Similar articles for PMID: 21502052

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Regulatory considerations for raw materials used in biological products.

Khan AS. Khan AS. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):451-7. PDA J Pharm Sci Technol. 2010. PMID: 21502052

Evolution of approaches to viral safety issues for biological products.

Lubiniecki AS. Lubiniecki AS. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):547-56. doi: 10.5731/pdajpst.2011.00818. PDA J Pharm Sci Technol. 2011. PMID: 22294576

Current testing methods and challenges for detection of adventitious viruses.

Khan AS. Khan AS. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):627-33. doi: 10.5731/pdajpst.2011.00831. PDA J Pharm Sci Technol. 2011. PMID: 22294589

Raw materials in the manufacture of biotechnology products: regulatory considerations.

Cordoba-Rodriguez R. Cordoba-Rodriguez R. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):445-50. PDA J Pharm Sci Technol. 2010. PMID: 21502051

Testing considerations for novel cell substrates: a regulatory perspective.

Khan AS. Khan AS. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):426-31. PDA J Pharm Sci Technol. 2010. PMID: 21502046

Theory and practice of conventional adventitious virus testing.

Gregersen JP. Gregersen JP. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):634-44. doi: 10.5731/pdajpst.2011.00832. PDA J Pharm Sci Technol. 2011. PMID: 22294590

Transmissible spongiform encephalopathies (TSE): minimizing the risk of transmission by biological/biopharmaceutical products: an industry perspective.

Kozak RW, Golker CF, Stadler P. Kozak RW, et al. Dev Biol Stand. 1996;88:257-64. Dev Biol Stand. 1996. PMID: 9119148

Review: production, characterization, and testing of banked mammalian cell substrates used to produce biological products.

Schiff LJ. Schiff LJ. In Vitro Cell Dev Biol Anim. 2005 Mar-Apr;41(3-4):65-70. doi: 10.1290/0503024.1. In Vitro Cell Dev Biol Anim. 2005. PMID: 16029074 Review.

Mycoplasma testing of cell substrates and biologics: Review of alternative non-microbiological techniques.

Volokhov DV, Graham LJ, Brorson KA, Chizhikov VE. Volokhov DV, et al. Mol Cell Probes. 2011 Apr-Jun;25(2-3):69-77. doi: 10.1016/j.mcp.2011.01.002. Epub 2011 Jan 11. Mol Cell Probes. 2011. PMID: 21232597 Review.

Regulatory expectations of validation/qualification of adventitious virus assays.

Baylis SA, Blümel J. Baylis SA, et al. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):486-91. PDA J Pharm Sci Technol. 2010. PMID: 21502057

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