Is Biopharma Ready to Say Goodbye to Batches?
Very few biologics are made using continuous processing equipment like bioreactors. Clearly, the biopharmaceutical industry has a long way to go before it’s ready to embrace (potentially) superior manufacturing models. Why?
Ronald A. Rader, Eric S. Langer |
Biopharmaceuticals are perhaps the most complex of all high-tech products, yet the most fundamental aspects of their manufacture have remained unchanged for decades. Most other modern industries have adopted continuous manufacturing (1), exemplified by the automobile assembly lines Henry Ford introduced over 100 years ago, petroleum refineries and newer steel mills, which run non-stop. In contrast, nearly all biopharmaceutical product manufacturing still involves batch processes.
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