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The function of a biologics facility is to safely and efficiently produce biologic products, generally in the form of therapeutic proteins. These proteins are created through the use of genetically modified cells to produce the desired product. Fermentation operations can be derived through the use of micro-organisms such a bacteria, yeast, plant, or mammalian cells. Each involves its own set of critical parameters-whether to control temperature, aeration, nutrient addition, or product withdrawal rates. All operations in a biologics facility must be considered critical and subject to the continued threat of batch contamination.
In addition to these operations, the critical support functions of media and buffer preparation, clean utility generation, and equipment cleaning and sterilization must be considered when designing a cGMP manufacturing facility.
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