Browse complete Report Therapeutic Monoclonal Antibody Production

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Bioprocessing is the branch of biotechnology dealing with the production and purification of biological materials of commercial interest. This report focuses on the wide ranging disciplines applied to the goal of rapidly, accurately and economically complex monoclonal antibody molecules. While most antibody biologics are anti-cancer agents, there are a number of other areas of disease management to which biologics in this class are starting to play a significant role. These indications include immune dysfunction, infectious disease and mental illness.

Trends in the upstream and the downstream areas of monoclonal antibody production are encouraging, and should provide help in holding down the costs of these very expensive biological molecules. As indicated in this report, the large expansion in the use of disposables in upstream and downstream unit operations of the production chain is underway. This shift away from fixed, reusable equipment is causing monumental changes in the industry, making available workable product quantities at affordable cost to cash strapped small companies while allowing clinical trials of promising but higher risk, second tier candidates to proceed. The exploding availability of disposables has caused major biotech companies to question their strategy of large capital investments in massive plants and reusable equipment.

This report identifies the continuing upstream versus downstream gap problem for the industry. Specifically, progress toward producing more protein per unit volume of culture medium has moved more rapidly to put pressure on the rates at which these materials can be purified on the downstream end. This overall expansion has motivated law-making bodies in Europe to redefine intellectual property guidelines and rules governing biogenerics. Legislation governing biosimilars has been passed in the US as part of the recent 2010 health care legislation.

This report also evaluates rising concern over the threat of Asian and European competition to the American bioprocessing industry.

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