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…
BioProcessing Journal Posts
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…
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…
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…
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…
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…