Assignment
In the highly regulated (bio)pharmaceutical industry the product and process development decisions not only critically influence the business operability of the given process but also its long-term viability from the regulation point of view. Compare and contrast the process development options and manufacturing strategies for a high value/low volume biopharmaceutical product. You should include a discussion on how the product characteristics affect the selection of the production organism and the processing route selection, the manufacturing and purification technologies used and how they are operated based on the product critical quality attributes (CQAs) and recovery yields required. You should also critically discuss the analysis and control techniques used to ensure consistent high-quality active product at each manufacturing stage.
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