Monoclonal Antibody Production (1999) / Chapter Skim
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Large-Scale Production of Monoclonal Antibodies
Large-Scale Production of Monoclonal Antibodies
Pages 25-32
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From page 25... ...
The therapeutic industry is highly regulated and sensitive to regulatory structure and to the very high regulatory cost of any procedural change. The biotechnology industry that develops therapeutic agents produces mAb on a small to medium scale; it is less concerned with cost of production than the diagnostic industry and much more concerned than the therapeutic industry, but turnaround time is very important.
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From page 26... ...
However, as the amount of mAb increases, existing in vitro production technology can become more economical because high, fixed optimization costs (costs associated with selecting a subclone with the best growth and mAb production characteristics and grow in low-serum or serum-free conditions) associated with in vitro production are spread over a larger production amount, making cost per gram competitive with in vivo production, which has a higher and more variable cost structure (figure 2~.
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From page 27... ...
Cost of producing 1 mg of mAb in mouse ascites, spinner flask (1 to 8L Belco spinners) , and mini (Spectrum CellMax)
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From page 28... ...
Biologic behavior also affects the concentration of mAb produced and, for the mouse ascites method, the quantity of ascites produced. Researchers and production facility personnel can optimize production results of both in vitro and in vivo methods by adjusting production variables and selecting appropriate clones.
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From page 29... ...
Selecting appropriate clones and altering hybridoma cell concentration injected into the peritoneal cavity of the mice are two ways to optimize production. The volume and concentration of mAb produced depend on the clone selected, and this makes systematic comparisons difficult.
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From page 30... ...
As the cost of disposable materials decreases further and technologic changes increase production efficiency and decrease equipment costs, the cost of in vitro production should decrease further, so it should become the preferred method of commercial production. Problems associated with in vitro systems today are as follows (note that the items in the following list do not necessarily apply to all the numerous in vitro systems mentioned above)
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From page 31... ...
To help avoid a major economic effect of such losses in commercial production, expensive facilities and tightly controlled procedures are implemented, all of which add to the high fixed cost of in vitro mAb production. REGULATORY REQUIREMENTS Regulatory requirements in the United States for in vitro and in vivo manufacturing of mAb have not changed considerably in the last two revisions of the "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" (FDA 1997~.
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From page 32... ...
As presented by the FDA Center for Biologics Evaluation and Research Division (Stein 1998) , it could take 3-8 years to obtain data needed to approve a product formerly produced by the ascites method and later produced in vitro.
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