Detection breadth and limits for potential adventitious/endogenous contaminants in biopharmaceutical processes: A reality check for innovative methods

Developments in Biologicals

Volumn 126, Issue , 2006, Pages 283-290

  Duncan, P ^a   McKerral, L ^a   Feng, S ^a   Tsai, P K ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

BACTERIUM; CONFERENCE PAPER; DRUG CONTAMINATION; FUNGUS; ISOLATION AND PURIFICATION; METHODOLOGY; POLYMERASE CHAIN REACTION; QUALITY CONTROL; VIRUS;

BACTERIA; DRUG CONTAMINATION; FUNGI; PHARMACEUTICAL PREPARATIONS; POLYMERASE CHAIN REACTION; QUALITY CONTROL; VIRUSES;

EID: 33748599559     PISSN: 14246074     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Conference Paper

References (19)

1. Schiff LJ: Review: Production, characterization, and testing of banked mammalian cell substrates used to produce biological products. In vitro Cell Dev Biol - Anim 2005;41:65-70.
2. European Pharmacopoeia 5th Edition, 2005.
3. United States Pharmacopeia-National Formulary (USP28-NF23), 2005.
4. Cundell A: Review of the media selection and incubation conditions for the compendial sterility and microbial limit tests. Pharm Forum 2002;28:2034-2041.
5. Food and Drug Administration (FDA) Center for Biologies Evaluation and Research. Aseptic processing guidance, Sept 2004.
6. Hu M, Buck C, Jacobs D, Paulino G, Khouri H: Application of PCR for detection and identification of mycoplasma contamination in virus stocks. In Vitro Cell Dev Biol - Anim 1995;31:710-715.
7. Uphoff CC, Drexler HG: Comparative PCR analysis for detection of mycoplasma infections in continuous cell lines. In vitro Cell Dev Biol - Anim 2002;38:79-85.
8. Wong-Lee JG, Lovett M: Rapid and sensitive PCR method for identification of mycoplasma species in tissue culture, in Persing DH, Smith TF, Tenover FC, While TJ (eds): Diagnostic Molecular Microbiology Principles and Applications. Washington, DC, American Society for Microbiology, 1993, pp 257-260.
9. Eldering JA, Felten C, Veilleux CA, Potts BJ: Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recomhinant therapeutic proteins. Biologicals 2004;32(4):183-193.
10. McAuliffe L, Ellis RJ, Ayling RD, Nicholas RAJ: Differentiation of mycoplasma species by 16S ribosomal DNA PCR and denaturing gradient gel electrophoresis fingerprinting. J Clin Microbiol 2003;41:4844-4847.
11. Chang A, Prud'homme I, Armstrong A, Hsieh WT, Presente E, Kerr A, Dean A, Dao MT, Onions D: Using Q-PCR for Mycoplasma Testing of Biopharmaceutical Products: The "HvMy" Assay. Presented at Well Characterised Biopharmceutical Products WCBP2005. Washington DC, Jan 2005.
12. ICH Harmonized Tripartite Guideline. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, 1997.
13. Beveridge WIB, Burnet FM: The cultivation of viruses and rickettsiae in the chick embryo. Med Res Council 1946, Special Report Series No. 256.
14. Fields BN, Knipe DM, Howley PM (eds): Melds Virology 3rd Ed. Philadelphia, Lippincott Raven, 1995.
15. Hsiung GD, CKY Fong, ML Landry (eds): Hsiung's Diagnostic Virology. 4th Ed. New Haven, Yale University Press, 1994.
16. Merten OW: Virus contaminations of cell cultures - A biotechnological view. Cytotechnoloey 2002;39:91-116.
17. Murray PR (ed): Manual of Clinical Microbiology 7th Edition. Washington DC, ASM Press, 1999.
18. Richman DD, Whitley RJ, Hayden FG (eds): Clincal Virology 2nd Ed. Washington DC. ASM Press, 2002.
19. ICH Harmonized Tripartite Guideline. Derivation and characterization of cell substrates used for production of biotechnological/biological products, 1997.