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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...

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.

Complex N-glycosylation of Recombinant Proteins by Insect Cells

by Laura A. Palomares and Octavio T. Ramírez
Volume 1, Issue 3 (Fall 2002)

The insect cell/baculovirus expression system typically results in more rapid expression and higher concentrations of recombinant proteins than what can be achieved with other animal cell culture systems. The lack of complex glycosylation in the proteins produced by this system, however, limits its use in the commercial-scale production of therapeutics. Complex glycosylation is required in many cases for adequate protein activity and pharmokinetic characteristics. In contrast to the protein's primary structure, which is encoded by the genetic material and is constant regardless of the host utilized, the extent of glycosylation is determined by the host, and by the protein itself. Even cells from different tissues of the same organism provide different glycosylation profiles. In addition, culture conditions and the cellular metabolic state can also influence protein glycosylation...

Palomares LA, Ramírez OT. Complex N-glycosylation of Recombinant Proteins by Insect Cells. BioProcess J, 2002; 1(3): 70-73.

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.

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