Upstream Manufacturing: Is An Open Or Closed System Better?

Bioprocess manufacturing is playing an increasingly important role in the healthcare sector and other fields, with products including proteins, monoclonal antibodies, and nucleic acids. Upstream manufacturing for these products often requires growing cells under carefully controlled conditions. Cell harvest is followed by downstream processes to test, purify, and package the products. For a research process to earn the necessary approvals to transition from research and development (R&D) to manufacturing is a tremendous achievement that comes with new challenges. Explore some factors to consider when making the critical decision on whether to use an open or closed system for the manufacturing process.