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FDA Perspectives on the Use of the Adenovirus Reference Material

by Stephanie Simek, PhD, Andrew Byrnes, PhD, and Steven Bauer, PhD
Volume 1, Issue 3 (Fall 2002)

As development proceeds for adenoviral vectors in gene transfer clinical trials, it becomes increasingly important that these products demonstrate a good safety profile, and thereby build confidence in those who must make decisions about risk/benefit ratios, dose escalation, and efficacy. Currently, safety and efficacy are based predominantly upon the analysis of data generated by non-standardized methods, resulting in inconsistent values being reported for virus titer and particle counts...

Citation:
Simek S, Byrnes A, Bauer S. FDA Perspectives on the Use of the Adenovirus Reference Material. BioProcess J, 2002; 1(3): 40-42.

 
A Statistical Analysis of Adenovirus Reference Material Assay Results

by Janice D. Callahan, PhD
Volume 1, Issue 3 (Fall 2002)

The Adenovirus Reference Material (ARM) was developed under the guidance of the Adenovirus Reference Material Working Group (ARMWG) and the U.S. Food and Drug Administration (FDA), and was made possible through the donation of services and supplies by a large number of laboratories and institutions from the United States, Canada, France, The Netherlands, Germany, and the United Kingdom. The purpose of the ARM is to provide a reference material for use in validating assays and internal standards for adenoviral particle concentration and infectious titer. The NIH Recombinant DNA Advisory Committee recommended the development of such a reference-testing agent in their report issued January 2002. The ARM consists of purified wild type 5 Adenovirus as described by ATCC's catalog number VR-5...

Citation:
Callahan JD. A Statistical Analysis of Adenovirus Reference Material Assay Results. BioProcess J, 2002; 1(3): 43-47.

 
Animal Viral Vaccine Manufacturing

by François Vanhersecke and Stephen W. Brown, PhD
Volume 1, Issue 3 (Fall 2002)

This paper reviews the manufacturing of veterinary viral vaccines and discusses the industry regulatory frameworks in both the European Union and the United States, the world's two largest regulatory markets. We also address specific technical and regulatory issues associated with viral vaccine inactivation. Finally, we present two case histories for conventional viral vaccines: Foot and Mouth Disease Virus (FMDV) and Marek's Disease, which are both long-established conventional vaccines, but nevertheless of great interest...

Citation:
Vanhersecke F, Brown SW. Animal Viral Vaccine Manufacturing. BioProcess J, 2002; 1(3): 48-52.

 
Risk Management Tools for the Management of Critical Raw Materials

by Robert M. Kennedy, PhD
Volume 1, Issue 3 (Fall 2002)

Risk management deals with planning for, and reacting to, hazard or loss. The regulatory authorities are focusing on the issues associated with establishing alternative sources of raw materials, especially as they are noticing a number of related quality problems in biopharmaceutical manufacturing. Supply chain management for critical raw materials used in biopharmaceutical manufacturing is an appropriate subject for risk management. This paper analyzes five important areas in risk management as it applies to the supply chain for critical raw materials...

Citation:
Kennedy RM. Risk Management Tools for the Management of Critical Raw Materials. BioProcess J, 2002; 1(3): 53-56.

 
A Contaminant in the Adenovirus Reference Material

by Gary Vellekamp, PhD, Sundari Ravindran, Mei Lin, Victoria Sluzky, and Elisabeth Lehmberg
Volume 1, Issue 3 (Fall 2002)

The Adenovirus Reference Material (ARM) is a purified and well-characterized wild type adenovirus (Ad5) now available to researchers worldwide. Due to the need for a common reference material, the ARM was produced with the purpose of validating assay methods and internal standards for use in developing recombinant adenovirus for gene therapy. Analysis of ARM by RP-HPLC, however, detected the presence of a contaminant peak with a distinctive A240 local wavelength maximum. The contaminant was found in all of the vials, with some variability in amount between vials. It appears that the contaminant is not associated with the virus and it is unlikely that it will interfere with the use of the ARM as a reference material. The source of the contaminant was probably a leachate or plasticizer from the tubing or containers used during the final processing step...

Citation:
Vellekamp G, Ravindran S, Lin M, Sluzky V, Lehmberg E. A Contaminant in the Adenovirus Reference Material. BioProcess J, 2002; 1(3): 57-61.

 
A Short-Term Field Use and Shipping Stability Study of a Wild Type Ad5 Adenoviral Reference Material

by Kodjo Adadevoh, Maria Croyle, Daniel Malarme, Edwige Bonfils, and Mark A. Bowe, PhD
Volume 1, Issue 3 (Fall 2002)

Adenoviral vectors for gene delivery are being tested in the clinic for a number of indications and therapeutic uses. In order to facilitate the comparison of studies from different laboratories, the Adenovirus Reference Material Working Group (ARMWG) has developed a reference testing reagent, which will be referred to as the Wild Type Ad5 Adenoviral Reference Material (ARM). This ARM will allow laboratories to standardize in-house controls employed in assays for the determination of particle concentration and infectious titer of their own adenoviral preparations. As part of this project, short-term field use and shipping studies were performed on the ARM. The virus was found to be stable under simulated shipping conditions, for one thaw after shipping, and at 4 °C for up to four hours after thawing. However, there was evidence of aggregation in some vials with repeated freeze-thaw cycles. Therefore, we recommend that each vial be treated as a single-use aliquot, and that it be used within four hours of thawing...

Citation:
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.

 
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