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Utility of a Recombinant Adeno-Associated Viral Vector Reference Standard

by Terence R. Flotte, Parris Burd, and Richard O. Snyder, PhD
Volume 1, Issue 3 (Fall 2002)

Recombinant adeno-associated viral (rAAV) vectors are known to be efficient vehicles for gene transfer in animal models. The attractive feature of this vector system consists primarily of long-term gene expression with little or no associated toxicities following administration to a variety of tissues. Previous and ongoing clinical trials in humans demonstrate a very good overall safety profile, but problems persist due to the lack of any systematic method for normalizing doses administered to animals and humans. To date, most of the work involves AAV serotype 2 vectors, but vector systems based on other AAV serotypes continue to develop rapidly. Administered doses are usually based on titer, but the defective nature of AAV makes determining vector infectious units difficult. Titering methods based on vector genomes (using hybridization, real-time PCR, or spectrophotometry) are more reliable, but give no information as to the infectivity of the vector. Determining infectious titer is critical, as the ratio of infectious virions to vector genome-containing virions helps to determine the dose, potency, and strength of the vector preparation...

Flotte TR, Burd P, Snyder RO. Utility of a Recombinant Adeno-Associated Viral Vector Reference Standard. BioProcess J, 2002; 1(3): 75-77.

Media Supply and Development

by Keith L. Carson
Volume 1, Issue 2 (Summer 2002)

Based on feedback received from a number of our recent conferences, cell culture media development remains one of the biggest challenges in the development of biological products. With more products reaching larger production scale and licensed production, it is becoming ever more important that we gain a better understanding of the media supply industry, and that we find ways to make media development more economical, reliable, and reproducible...

Carson KL. Media Supply and Development. BioProcess J, 2002; 1(2): 25-28.

Manufacturing Biological Clinical Materials by a Dual Track "Traditional/Transgenic" Approach

by Brandon J. Price, PhD
Volume 1, Issue 2 (Summer 2002)

By virtually any measure, constraints in current manufacturing capacity are hindering the development of new biologic drugs, as well as the greater market penetration of several licensed biologics. This capacity demand is being driven not only by the increasing number of new biologics being approved, but by the number of biologics that are in the product development pipeline. Figure 1 shows United States FDA biologics approvals for the 20-year period from 1981-2000. While there is year-to-year variability in approvals, especially in later years, the five-year averages show a doubling in the annual rate of product approval for each successive five-year period. Clearly, these averages cannot continue to increase at the same rate. In fact, only six biologics were approved by the FDA in 2001...

Price BJ. Manufacturing Biological Clinical Materials by a Dual Track "Traditional/Transgenic" Approach. BioProcess J, 2002; 1(2): 30-35.

A Rapid Method for the Capture and Purification of a Protease Sensitive Protein

by Christopher W. Kemp, PhD
Volume 1, Issue 2 (Summer 2002)

The baculovirus expression vector system (BEVS) is one method utilized for the production of recombinant proteins, and typically works without significant difficulties. However, some proteins are produced in insoluble forms, and degradation can occur. This article will focus on this degradation issue, and present a method to stabilize a protease-sensitive protein that has been produced at the 40-liter scale...

Kemp CW. A Rapid Method for the Capture and Purification of a Protease Sensitive Protein. BioProcess J, 2002; 1(2): 36-39.

Risk Analysis of Raw Materials Used in Mammalian Cell Culture Media

by Trish Benton and Thomas C. Thomas
Volume 1, Issue 2 (Summer 2002)

Growth media for mammalian cell culture are complex mixtures of raw materials that include amino acids, vitamins, inorganic salts and a wide variety of other components. The risk of infectious agent transmission, when some of these components are derived directly from animals, is a major concern in the biopharmaceutical industry, and is being actively addressed. However, the risk associated with the use of indirectly, or secondarily, derived animal components is less recognized and addressed. We have developed a classification system to define the contact level that a cell culture medium component has had with animal-derived materials. This classification system has increased the accuracy and reliability of the information we are able to obtain from raw material manufacturers, and is being used as part of a risk assessment analysis for a serum/protein-free media we are moving from development into manufacturing...

Benton T, Thomas TC. Risk Analysis of Raw Materials Used in Mammalian Cell Culture Media. BioProcess J, 2002; 1(2): 40-42.

Large-Scale Production of Active Serine-Threonine Kinases of the MAPK Pathway Using the Baculovirus System

by Steven L. Nguyen and Wai-Ping Fung-Leung, PhD
Volume 1, Issue 2 (Summer 2002)

Serine-threonine kinases of the Mitogen Activated Protein Kinase (MAPK) pathway represent potential drug targets for a wide range of diseases. As part of an effort to understand the biology of the pathways, several human serine-threonine MAPKs were produced. Optimization and modification of current methodologies used in the baculovirus expression system resulted in the generation of large amounts of active MAPKs. Compounds found to inhibit the MAPKs in vitro, subsequently showed activity in cell-based assays and animal models. The processes to be discussed were developed to yield large quantities of three active human serine-threonine MAPKs by the baculovirus expression system...

Nguyen SL, Fung-Leung W-P. Large-Scale Production of Active Serine-Threonine Kinases of the MAPK Pathway Using the Baculovirus System. BioProcess J, 2002; 1(2): 43-46.

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