Herceptin: The Making of a Medicine The manufacture of a biologic medicine, a monoclonal antibody, is a complex and time-intensive process. The biopharmaceutical manufacturing process begins with a small quantity of the protein medicine-producing cells. In the case of Herceptin, these are mammalian cells. Technicians cultivate and grow these starter cells in increasingly larger quantities, a process called "scaling up" that takes one or more months. After "scaling up," the cell cultures are transferred to production containers where the cells are allowed to secrete the desired protein. Next, the protein medicines these cells produce are separated from the cellular materials, the growing medium is filtered out, and the protein medicine is purified. To ensure quality, the purified bulk medicine undergoes extensive testing, which takes from one to three months. If the bulk medicine is pure and active it gets "filled," put into small use-size vials, and freeze dried. The final "filled" product undergoes an additional three or more months of exhaustive testing before it is acceptable for release. Genentech, Inc., which manufactures Herceptin, is working on ways to increase production while maintaining safety and quality. Herceptin was approved for metastatic breast cancer by the FDA in the Fall of 1998. Early in October, some women in our Recurrence Support Group began Herceptin treatment with their oncologists. A few of our women friends had the courage to be in the HER2 neu clinical trials. We thank them for their courage which has produced a new treatment gift for others. If you are newly diagnosed with breast cancer, currently being treated, or in remission you might benefit from HER2 screening. If your tissue is positive for HER2 amplification and overexpression, valuable information about your prognosis can be gained. There are several tests that can measure HER2 expression and amplification. Two of the most common are IHC (immunohistochemistry) and FISH (fluorescence in situ hybridization) which are applied to tissue samples. Existing tissue samples can be used, even if they are several years old, provided they have been appropriately stored.
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