Bibliography
- Devuyst O , BeauvensR, DenefJF, CrabbeJ, AbramovM: Subtypes of Madin–Darby canine kidney (MDCK) cells defined by immunocytochemistry: further evidence for properties of renal collecting ducts.Cell Tissue Res.277 , 231–237 (1994).
- Liu J , ManiS, SchwartzR, RichmanL, TaborDE: Cloning and assessment of tumorigenicity and oncogenicity of a Madin–Darby canine kidney (MDCK) cell line for influenza vaccine production.Vaccine28 , 1285–1293 (2010).
- Medema JK , MeijerJ, KerstenAJ, HortonR: Safety assessment of Madin Darby Canine Kidney Cells as vaccines substrate.Dev. Biol. (Basel)123 , 243–250 (2006).
- Zambon M : Cell culture for surveillance of influenza.Dev. Biol. Stand.98 , 65–71 (1999).
- Minor PD , EngelhardtOG, WoodJMet al. : Current challenges in implementing cell-derived influenza vaccines: implications for production and regulation.Vaccine27 , 2907–2912 (2009).
- Schild GC , OxfordJS, DeJongJC, WebsterRG: Evidence for host-cell selection of influenza virus variants.Nature303 , 706–709 (1983).
- Oxford JS , CororanT, KnottRet al. : Serological studies with influenza A (H1N1) viruses cultivated in eggs or in canine kidney cell line (MDCK).Bull. WHO65 , 181–187 (1987).
- Robertson JS : Clinical influenza virus and the embryonated hen‘s egg.Med. Virol.3 , 97–106 (1993).
- Katz JM , WebsterRG: Efficacy of inactivated influenza A virus (H3N2) vaccine grown in mammalian cells or embryonated eggs.J. Infect. Dis.160 , 191–198 (1989).
- Committee for medical products for human use (CHMP): Concept paper on the need to update the current annex guideline on cell culture inactivated influenza vaccines with respect to the derivation of cell-isolated influenza vaccine viruses. EMEA/CHMP/BWP/481473/2008, EMEA, London, 22 January 2009.
- European Medicines Agency: Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture. Draft released for consultation. EMA/CHMP/BWP/68803/2010. Available online: see [105].
- ICH International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use: Harmonized Tripartite Guideline on viral safety evaluations of biotechnology products”. ICH Q5A, Geneva 1997. See also CPMP/ICH/295/95: Note for guidance on quality of biotechnology products derived from cell lines of human or animal origin. CPMP/ICH/295/95 (2007). Available online: see [105].
- Food and Drug Administration: Guidance for Industry. Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases. US Food and Drug Administration (2006). Available online: see [106].
- Trusheim H , RothB, WilmsRet al. : The MDCK 33016-PF cell line is not only suitable for the production of cell-based influenza vaccine but is also an ideal substrate for influenza virus isolation. Presented at:Options for the Control of Influenza VI, Toronto, Canada, 17–23 June2007.
- Gregersen JP : A quantitative risk assessment of exposure to adventitious agents in a cell culture-derived subunit influenza vaccine.Vaccine26 , 3332–3340 (2008).
- Onions D , EganW, JarrettR, NovickiD, GregersenJP: Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.Biologicals38 , 544–551 (2010).
- Liu J , ShiX, SchwartzR, KembleG: Use of MDCK cells for production of live attenuated influenza vaccines.Vaccine27 , 6460–6463 (2009).
- Yang H , ZhangL, GalinskiM: A probabilistic model for risk assessment of residual host cell DNA in biological products.Vaccine28 , 3308–3311 (2010).
- Gregersen JP : A risk-assessment model to rate the occurrence and relevance of adventitious agents in the production of influenza vaccines.Vaccine26 , 3297–3304 (2008).
- Polymenidou M , TrusheimH, StallmachLet al. : Canine MDCK cell lines are refractory to infection with human and mouse prions.Vaccine26 , 2601–2614 (2008).
- Ambrozaitis A , GrothN, BugariniR, SparacioV, PoddaA, LattanziM: A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine.Vaccine27 , 6022–6029 (2009).
- Symczakiewicz-Multanowska A , GrothN, BugariniRet al. : Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture.J. Infect. Dis.200 , 841–848 (2009).
- Reisinger KS , BlockSL, IzuA, GrothN, HolmesSJ: Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.J. Infect. Dis.200 , 849–857 (2009).
- Frey S , VesikariT, Szymczakiewicz-MultanowskaAet al. : Clinical efficacy of cell culture-derived and egg-derived inactivated influenza vaccines in healthy adults.Clin. Infect. Dis.51 , 997–1004 (2009).
- Collin N , deRadiguès X: Vaccine production capacity for seasonal and pandemic (H1N1) 2009 influenza.Vaccine27 , 5184–5186 (2009).
- Schmitt HJ , GregersenJP, TrusheimH, BrökerM: [Safety of cell culture-based influenza vaccines].Med Monatsschr Pharm.33(1) , 4–10 (2010).
- Rappuoli R . Cell-culture-based vaccine production. Technological Options.The Bridge36(3) , 25–30 (2006).
Websites
- World Health Organization: Requirements for the use of animal cells as in vitro substrates for the production of biologicals. WHO Technical Report Series No. 878, (1998) www.who.int/biologicals/publications/trs/areas/vaccines/cells/WHO_TRS_878_A1Animalcells.pdf
- Influenza Cell Culture Subunit Vaccine, Vaccine and Related Biological Products Advisory Committee (VRBPAC), Briefing Document Chiron, Bethesda, 16 November, 2005 www.fda.gov/ohrms/dockets/AC/05/briefing/5–4188B1_18.pdf
- Vaccine and Related Biological Products Advisory Committee (VRBPAC), November 2005, Madin Darby Canine Kidney Continuous Cell Line, Briefing Document Solvay www.fda.gov/ohrms/dockets/AC/05/briefing/5–4188B1_19a.pdf
- Patriarca PA . Use of cell lines for the production of influenza virus vaccines: an appraisal of technical, manufacturing, and regulatory considerations. Geneva: World Health Organization, April 10, 2007www.who.int/vaccine_research/diseases/influenza/WHO_Flu_Cell_Substrate_Version3.pdf
- ICH and EMA Guidelines www.ema.europa.eu
- FDA Guidelines www.fda.gov/cber/guidelines.htm
- EPAR (European Public Assessment Report) Optaflu®, EMEA 2007 www.emea.europa.eu/humandocs/PDFs/EPAR/optaflu/H-758-en6.pdf
- Centers for Disease Control and Prevention www.cdc.gov/vaccines/vpd-vac/rotavirus/default.htm