Chapter 10 Upstream Processing - Biomanufacturing
upstream processing is the growth of either bacterial or cell culture-based protein products, referred to as microbial fermentation or mammalian cell culture respectively. These disease-fighting proteins are collectively called Active Pharmaceutical Ingredients, or APIs
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biomanufacturing.orgcontainers (pharmaceutical container/closure). This operation exposes the sterile product to the environment, equipment, and manipulative technique of the operators until it can be sealed in the dose container; therefore, this operation is performed with a minimum exposure
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