INFORMATION PACKAGE

VRBPAC, Nov 16, 2005

 

TABLE OF CONTENTS

 

Copies of the CBER presentations to the Committee:

 

Presentation (slides) by Philip Krause:

Presentation by Andrew M. Lewis Jr,

Presentation by Arifa Khan

Presentation by Keith Peden

 

References related to CBERs approach to using neoplastic cell substrates for vaccine manufacture: Krause talk

 

Lewis, Peden, and Krause, A defined-risks approach to the regulatory assessment of the use of neoplastic cells as substrates for viral vaccine manufacture, Dev Biol, 106, 513-535, 2001

 

References related to tumorigenicity testing:  Lewis talk

 

Lewis et al. Evaluating virus-transformed cell tumorigenicity, J Virol Meth 79: 41-50, 1999

 

Reid et al. Virus carrier state suppresses tumorigenicity of tumor cells in athymic (nude) mice, J Gen Virol 42: 609-614, 1979

 

Hahn and Weinberg, Modeling the molecular circuitry of cancer, Nature Rev 2: 331, 2002

 

Dragan, et al. Biochemical events during initiation of rat hepatocarcinogenesis,

Carcinogenesis, 15: 1451-1458, 1994

 

References related to adventitious agent testing including cell lysates: Khan talk

 

Nicklas et al., Contamination of transplantable tumors, cell lines, and monoclonal antibodies with rodent viruses, Laboratory Animal Science 43: 296-299, 1993

 

Khan and Sears, Pert analysis of endogenous retroviruses induced from K-BALB mouse cells treated with 5-iododeoxyuridine: a potential strategy for detection of inducible retroviruses from vaccine cell substrates, in Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development, Dev Bio 106: 387-393, 2001

 

Ono, Detection and elimination of endogenous retroviruses and retrovirus-like particles in continuous cell lines, Dev Biol Stand 70: 69- 81, 1988

 

Robertson, Viruses and assuring viral safety, Dev Biol 113: 73-77, 2003

 

Onions, Animal virus contaminants of biotechnology products, Dev Biol 118: 155-163, 2004

 

Partial List of Oncogenic Viruses (Table)

 

References related to testing of cell substrate DNA for oncogenicity and infectivity: Peden talk

 

Burns et al., Transformation of mouse skin endothelial cells in vivo by direct application of plasmid DNA encoding the human T24 H-ras oncogene, Oncogene 6: 1973-1978, 1991

 

Kurth, Risk potential of the chromosomal insertion of foreign DNA, Dev Biol Stand 93: 45-56, 1998

 

Petricciani and Horaud, DNA, Dragons and Sanity, Biologicals 23: 233-238, 1995

 

Peden et al., Biological activity of residual cell substrate DNA, Dev Biol Stand 123: 2004.

 

Transcripts of the following VRBPAC meeting involving the use of neoplastic cell substrates for vaccine manufacture can be obtained on line at:

 

11/19/98 Advisory Committee Meeting Transcript

http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3476t1.rtf

 

5/12/00 Advisory Committee Meeting Transcript (Session 6)

http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3616t2a.pdf

http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3616t2b.pdf

 

5/16/01 Advisory Committee Meeting Transcript

http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1.rtf

 

The regulatory documents listed below can be obtained on line at the indicated web sites.

 

CBER Points to Consider on the Characterization of Cell Lines Used to Produce Biologicals 1993 http://www.fda.gov/cber/gdlns/ptccell.pdf

 

ICH Q5D Quality of Biotechnology and Biological Products Fed Reg 63: 182, 50244, 1998 http://www.fda.gov/cber/gdlns/qualbiot.pdf

ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human and Animal Origin Fed Reg 63 185: 51074, 1998  http://www.fda.gov/cber/gdlns/virsafe.pdf

 

 

 


Ianconescue et al., Comparative susceptibility of a canine cell line and bluetongue virus susceptible cell lines to a bluetongue virus isolate pathogenic for dogs, In Vitro Cell Dev Biol Anim 32: 249-54, 1996

 

Khan, Retrovirus screening of vaccines cell substrates, in  Viral safety and evaluation of viral clearance from biopharmaceutical products, Dev Biol Stand 88: 157-162, 1996

 

Robertson, Viruses and assuring viral safety, Dev Biol 113: 73-77, 2003

 

Jacobson et al., Determinants of spontaneous recovery and persistence in MDCK cells infected with lymphocytic choriomeningitis virus, J Gen Virol 44: 113 -1 121, 1979

 

 

WHO Technical Report Series Requirements for the use of animal cells as in vitro substrates for the production of biologicals,  878, 19 - 53,  1998,

 

WHO Technicasl Report Series Part C Requirements for human diploid cells used for virus vaccine production 673: 64-77, 1982