Monoclonal antibodies constitute a significant percentage of the protein-based therapeutic molecules currently in clinical trials. The broad applicability and proven commercial success for this class of molecules suggest a larger future market potential. The current biopharmaceutical manufacturing capacity is widely anticipated to be a rate-limiting factor in the growth of the biotech sector. Because antibody therapeutics represent such a large part of this market, and because the therapeutic dosages of antibodies tend to be greater than most biopharmaceuticals, there is an immediate need for novel antibody manufacturing approaches that deliver significantly greater productivity…
Category: <span>Manufacturing</span>
Cellular therapy is currently generating great interest in the treatment of a variety of diseases. In turn, this interest has stimulated the Center of Biologics Evaluation and Research of the Food and Drug Administration to examine its regulatory approach to the products used for these therapies. As a result, facilities preparing cell therapy products are now regarded as manufacturers, and are expected to comply with current Good Manufacturing Practices and/or the proposed current Good Tissue Practices. Compliance with these practices can be a culture shock to some academic centers whose background is firmly in research. The FDA has indicated that there is a sliding scale of compliance depending on the phase of the clinical study. The difficulty for centers is deciding where they fall on the compliance scale, as well as determining what changes must be made to come into compliance. This article reviews some of the factors that must be considered when making these decisions…
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…
Protein-based therapeutics have led to the emergence of the biotechnology industry and should drive rapid growth in the industry over the next decade. In 2001 alone, six major biologics were approved by the FDA. According to our analysis, there are 39 biologic products (antibodies and non-antibody recombinant proteins) that are currently in Phase III clinical testing and about 60 in Phase II testing, which we estimate could lead to 34 new products on the market in the next four to six years. By our estimates, such a new product outpouring would lead to more than a doubling of the number of profitable biopharmaceutical product companies (currently 15) by mid-decade. The focus of this report is to evaluate the manufacturing aspects of biotechnology models and analyze the current and future capacity needs of the industry…
As you stand on the brink of finalizing your first Investigational New Drug (IND) application for a cellular therapy product, there is always the question looming in the back of your mind. “What did we forget?” Hopefully, the answer is “Nothing.” However, it is always good to undergo a review of the standard systems needed in order to transition from research to clinical manufacturing. This article describes an overview of the basic regulatory guidelines and quality systems necessary to begin clinical trials under the regulations of the Food and Drug Administration. However, this should only be considered a guideline, as it does not necessarily address the standards of other regulatory agencies. The investigational product, the clinical indication, and the manufacturing materials used in the investigational product can also change the regulatory requirements needed to proceed with the initiation of clinical trials…