In today’s biopharmaceutical pipeline, monoclonal antibodies are a predominant modality for a broad range of clinical indications, including inflammatory disorders, oncology, and infectious diseases. More than two dozen antibody-based products are commercially available. In 2004, six of the 12 new biopharmaceutics that gained approval in the United States and Europe were antibody-based products. Most antibody therapies require high doses over a long period of time, which requires large amounts of purified product per patient. Therefore, manufacturing capacity to meet the demands of antibody production is a real challenge. It is desirable to have highly productive and consistent manufacturing processes. In addition, speed to market is critical to deliver health benefits to patients quickly and to achieve business success…
Tag: <span>antibody therapeutics</span>
In general, the industry has gone through another of its realignment periods, where much was learned, but a lot of restructuring and refocusing took place. Driven by the need to keep the doors open, small to medium sized firms had to do some severe belt tightening, or completely redefine themselves as to technologies, products, and personnel. Many of the larger firms reevaluated their product pipelines, and then made the changes they felt were necessary to assure future revenues, or to make themselves attractive merger partners. Numerous large mergers took place with some that were the largest the biopharmaceutical industry has ever seen. In addition, several medium-sized companies merged, or otherwise found strategic alliances that energized their product pipelines, or simply provided the cash they needed to keep going. Antibody products did very well with a number of blockbusters receiving license approval in 2003…
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…
Over 25 years have elapsed since Kohler and Milstein electrified the immunology community with their article describing the reliable preparation of monoclonal antibodies (MAbs) by fusing immune splencytes with immortalized myeloma cells. This discovery not only garnered the pair of scientists a Nobel Prize, but also led to the development of a technology which has yielded a number of important therapeutic, prophylactic, and diagnostic products for in vivo human use, and hundreds of in vitro diagnostic products. Some of these products proved to be significant in meeting previously unmet medical needs, and a few have been commercial successes. But the path, from Kohler and Milstein’s discovery to commercial products, was discontinuous and a bit bumpy, and the technology continues to evolve…