MATERIALS AND METHODS
Production
Characterization
REFERENCES
Related Articles
- Adadevoh K, Croyle M, Malarme D, Bonfils E, Bowe MA. A Short-Term Field Use and Shipping Stability Study of a Wild Type Ad5 Adenoviral Reference Material. BioProcess J, 2002; 1(3): 62-69.
- Callahan JD. A Statistical Analysis of Adenovirus Reference Material Assay Results. BioProcess J, 2002; 1(3): 43-47.
- Carson KL. Reference Materials for Complex Biological Products. BioProcess J, 2003; 2(1): 17-21.
- Hutchins B. Development of a Reference Material for Characterizing Adenovirus Vectors. Bioprocess J, 2002; 1(1): 25-29.
- Hutchins B, Sajjadi N, Seaver S, Shepherd A, Steven R. Bauer SR, Simek S, Carson K, Aguilar-Cordova E. Working Toward an Adenoviral Vector Testing Standard. Mol Ther, 2000; 2(6): 532-534.
- Lehmberg E, Shabram P, Schluep T, Wen SF, Sugarman B, Croyle M, Koehl M, Bonfils E, Malarme D, Sharpe G, Nesbit H, Borellini F, Kamen A, Hutchins B, Vellekamp G. Adenovirus Reference Material: Determination of Particle Concentrations Obtained by Orthogonal, Physical-Chemical Methods. BioProcess J, 2003; 2(3): 50-55.
- Sajjadi N, Callahan J. Defining a Detailed Approach to Using the Adenovirus Reference Material (ARM). BioProcess J, 2003; 2(5): 83-87.
- Simek S, Byrnes A, Bauer S. FDA Perspectives on the Use of the Adenovirus Reference Material. BioProcess J, 2002; 1(3): 40-42.
- Sugarman BJ, Hutchins BM, McAllister DL, Lu F, Thomas KB. The Complete Nucleic Acid Sequence of the Adenovirus Type 5 Reference Material (ARM) Genome. BioProcess J, 2003; 2(5): 27-33.
- Vellekamp G, Ravindran S, Lin M, Sluzky V, Lehmberg E. A Contaminant in the Adenovirus Reference Material. BioProcess J, 2002; 1(3): 57-61.
- Zhao Y, Thorpe R. Standardisation of Gene Therapy Products: Practical Considerations and Perspectives. BioProcess J, 2004; 3(6): 21-25.
Summary Presentations
- B. Sugarman at WilBio, Viral Vectors & Vaccines (VVV) 2002
- S. Simek at PHARMA, April 2002
- S. Simek at ICH 2002
- Presentations Given at the RAC Meeting in Bethesda, Maryland – December 15, 2000
- Presentations Given at the NIH Public Meeting – February 1, 2001
- Presentation, S. Bauer, February 1, 2001
- Presentation, S. Simek, February 1, 2001
- Presentation, B. Hutchins, February 1, 2001
Meeting Minutes
- Meeting Minutes, November 8, 2000
- Meeting Transcript, February 1, 2001
- Timeline, January 29, 2001
- Meeting Minutes, March 22, 2001
- Meeting Agenda, March 22, 2001
- Meeting Minutes, May 31, 2001
- Meeting Agenda, May 31, 2001
- ASGT 2001, Working Group Announcement
- Meeting Minutes (Telecon), June 11, 2001 on Testing Cell Bank
- Meeting Minutes (Telecon), August 9, 2001 on Long-Term Stability
- Meeting Minutes, September 5, 2001
- Meeting Agenda, September 5, 2001
- Action Items from September 5, 2001 Meeting
- Meeting Minutes (Telecon), March 25, 2002
- Meeting Minutes (Telecon), April 11, 2002 on Contaminant Peak
- Meeting Minutes (Telecon), June 6, 2002
- Meeting Results, June 6, 2002
- Meeting Results, June 6, 2002 on Sample Size CV
- Proposal, Shabram & Sajjadi, June 6, 2002
- Sample Size Table, June 6, 2002