Literature References and Links
This section of the site contains the references relevant to each of the services pages and links to the related documents in PDF format.
In
vitro Adventitious Virus Assays
References:
1) European
Pharmacopoeia (Ph.Eur.). 2.6.16. Tests for extraneous agents in
viral vaccines for human use.
2) European
Pharmacopoeia (Ph.Eur.). General Chapter 5.2.3. Cell substrates
for the production of vaccines for human use.
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ICH Q5a Viral Safety Evaluation |
FDA Guidelines for Vaccines Draft 2006 |
EMEA 2006 Draft |
FDA PTC 1993 |
FDA Draft Guidance 2004 CMC Information |
Retrovirus
Assays
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ICH Q5a Viral Safety Evaluation |
FDA Guidelines for Vaccines Draft 2006 |
EMEA 2006 Draft |
FDA PTC 1993 |
FDA PTC 1997 |
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FDA Draft Guidance 2004 CMC Information |
FDA Guidance Supplement Replication Competent Retrovirus |
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Electron Microscopy
References:
1)
European Pharmacopoeia (Ph.Eur.). General Chapter 5.2.3. Cell substrates
for the production of vaccines for human use.
2)
Reid, G.G., Milne, E.W., Coggins, L.W., Wilson, N.W., Smith, K.T.
and Shepherd A.J. (2003) Comparison of electron microscopic techniques
for enumeration of endogenous retrovirus in mouse and Chinese hamster
cell lines used for production of biologics. J.Virol.Meth. 108:91-96.
3)
Milne, E.W. (2003) Electron Microscopy: Current Techniques Used
in Product Safety. BioProcessing Journal 2:2,65-68.
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ICH Q5a Viral Safety Evaluation |
FDA Guidelines for Vaccines Draft 2006 |
EMEA 2006 Draft |
FDA PTC 1993 |
FDA PTC 1997 |
Residual
Host Cell DNA Assays
References:
1)
European Pharmacopoeia (Ph.Eur.). 2.6.21. Nucleic acid amplification
techniques.
2) European Pharmacopoeia (Ph.Eur.). 5.14. Gene transfer medicinal
products for human use.
3) European Pharmacopoeia (Ph.Eur.). 01/2008:0784. Recombinant DNA
technology, products of.
4) Lovatt, A. (2001). Applications of quantitative PCR in the biosafety
and genetic stability assessment of biotechnology products. Reviews
in Molecular Biotechnology, 82: 279-300.
5) Lovatt et al., 2002. Validation of QPCR assays: Addressing viral
contamination concerns. BioPharm, March 2002. ADVANSTAR publication.
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FDA Draft Guidance 2004 CMC information |
FDA Guidelines for Vaccines Draft 2006 |
ICH Q2 |
CPMP 1997 |
FDA PTC 1997 |
RT
Assays
References:
1)
Lovatt, A, Black J, Galbraith D, Doherty I, Moran MW, Shepherd AJ,
Griffen A, Bailey A, Wilson N, and KT Smith. (1999). High throughput
detection of retrovirus-associated reverse transcriptase using an
improved fluorescent product enhanced reverse transcriptase assay
and it’s comparison to conventional detection methods. Journal
of Virological Methods, 82: 185-200.
2)
Lovatt, A. (2002). Applications of quantitative PCR in the biosafety
and genetic stability assessment of biotechnology products. Reviews
in Molecular Biotechnology, 82: 279-300.
3)
Xu, Y and K Brorson. (2003). An overview of quantitative PCR assays
for biologicals: quality and safety evaluation. Dev Biol (Basel),
113:89-98.
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FDA Draft Guidance 2004 CMC information |
FDA Guidelines for Vaccines Draft 2006 |
EMEA 2006 |
FDA PTC 1993 |
FDA PTC 1997 |
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CBER Letter to Industry 1998 |
ICH Q5A Viral Safety Evaluation |
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Species-specific
Virus Detection by qPCR
References:
1)
Lovatt, A. (2002). Applications of quantitative PCR in the biosafety
and genetic stability assessment of biotechnology products. Reviews
in Molecular Biotechnology, 82: 279-300.
2) Xu, Y and K Brorson. (2003). An overview of quantitative PCR
assays for biologicals: quality and safety evaluation. Dev Biol
(Basel), 113:89-98.
3) Lovatt et al., 2002. Validation of QPCR assays: Addressing viral
contamination concerns. BioPharm, March 2002. ADVANSTAR publication.
Downloads - Right click icon and choose 'Save Target As' to save file to disk.
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FDA Draft Guidance 2004 CMC information |
FDA Guidelines for Vaccines Draft 2006 |
EMEA 2006 |
FDA PTC 1993 |
FDA PTC 1997 |
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ICH Q5A Viral Safety Evaluation |
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Mycobacteria
Assay
References:
European
Pharmacopoeia (Ph.Eur.). 2.6.16. Tests for extraneous agents in
viral vaccines for human use.
European
Pharmacopoeia (Ph.Eur.) 2.6.2. Mycobacteria
Mycoplasma
Assays
References:
1) US
Code of Federal Regulations
2) FDA
Center for Biologics Evaluation and Research “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”
3) FDA
“Points to Consider in the Characterisation of Cell Lines
Used to Produce Biologicals”
4) Ph.Eur.
2.6.7 European Pharmacopoeia (2.6.7 Mycoplasmas)
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FDA Draft Guidance 2004 CMC information |
Genetic Stability of Cell Lines
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Considerations for Plasmid DNA Vaccines |
FDA Guidelines for Vaccines Draft 2006 |
ICH Q5B |
Supplement to FDA PTC (Genetic Stability) |
Patient
Monitoring & Biodistribution Studies
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CHMP Concept paper 2007 |
FDA Guidance Gene Therapy Clinical Trial |
FDA Guidance Somatic & Gene Therapy |
Sterility
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21 CFR 610.12 (Sterility) |
ICHQ 5D |
Mycoplasma
Assays
References:
1) US
Code of Federal Regulations
2) FDA
Center for Biologics Evaluation and Research “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”
3) FDA
“Points to Consider in the Characterisation of Cell Lines
Used to Produce Biologicals”
4) Ph.Eur.
2.6.7 European Pharmacopoeia (2.6.7 Mycoplasmas)
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21 CFR 610.30 |
FDA Guidance for vaccines Draft 2006 |
FDA PTC 1993 |
Mycoplasma
qPCR Assays
References:
1) Ph.Eur.
2.6.7 European Pharmacopoeia (2.6.7 Mycoplasmas)
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FDA Draft Guidance 2004 CMC Information |
Mycobacteria Assays
References:
1) European Pharmacopoeia (Ph.Eur.). 2.6.16. Tests for extraneous agents in viral vaccines for human use.
2) European Pharmacopoeia (Ph.Eur.) 2.6.2. Mycobacteria
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FDA Guidance for Vaccines Draft 2006 |
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