Practicing safe cell culture: Applied process designs for minimizing virus contamination risk

PDA Journal of Pharmaceutical Science and Technology

Volumn 65, Issue 6, 2011, Pages 715-729

  Kiss, Robert D ^a  

^a GENENTECH INC   (United States)

Author keywords

Contamination prevention; Contaminations lessons learned; High temperature short time; HTST; Minute mouse virus; MMV; Murine parvovirus; MVM; Raw material risks; Virus contamination; Virus contamination risk; Virus safety

Indexed keywords

ANALYTIC METHOD; BIOREACTOR; CELL CULTURE; CELL GROWTH; CELL VIABILITY; CHO CELL; CONFERENCE PAPER; DOWNSTREAM PROCESSING; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; HUMAN; NONHUMAN; PARVOVIRUS; PARVOVIRUS INFECTION; POLYMERASE CHAIN REACTION; PROCESS DESIGN; PROTECTION; RISK ASSESSMENT; THERMAL EXPOSURE; VIRAL CLEARANCE; VIRAL CONTAMINATION; VIRUS PARTICLE; CELL CULTURE TECHNIQUE; DRUG CONTAMINATION; FOOD CONTAMINATION; PREVENTION AND CONTROL; RISK; SAFETY; VIRUS;

BIOLOGICAL PRODUCT;

BIOLOGICAL PRODUCTS; CELL CULTURE TECHNIQUES; DRUG CONTAMINATION; FOOD CONTAMINATION; HUMANS; RISK; SAFETY; VIRUSES;

EID: 84855561667     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: 10.5731/pdajpst.2011.00852     Document Type: Conference Paper

References (9)

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7. Genentech internal study, 1994 (unpublished results).
8. Boychyn, R. M. Design of a Contamination Barrier for Serum-Containing Cell Culture Media of a Licensed Product, IBC Conference Presentation, September 2010, Providence, RI.
9. Kiss, R.; Widrig, R.; Magreta, P.; Quan, C.; Cacia, J. Validation of Viral Barriers for Large Scale Cell Culture Medium. American Chemical Society Division of Biochemical Technology Presentation, April 1997, San Francisco, CA.