Article: Process Development: Turning Science Into Technology

Manufacturing process development is crucial to the success of a biotherapeutic entity. Even the best "miracle drug" will make it to just a select few patients if it's too expensive to make—and if it's too delicate to survive processing and/or delivery, even that may be too much to ask.

Bioprocess development is at its most basic level a series of options. Typically, a biologic product is made by microbial or animal cells in a fermentor or bioreactor, from which a mixture is recovered and separated until the molecule (s) of interest can be purified out from it. At that point, purified "bulk" drug goes into final processing (formulation) and packaging.

Reprinted with permission from BioProcess International 4(2) (March 2006)

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