Pharma Industry Making a Move
Moving from batch to continuous processing may not seem like a major issue, but that’s not the case in the pharmaceutical and biotechnology industry. Continuous processing works fine in most high-volume industries with well-known processes. But pharma is a highly regulated, largely batch-oriented industry that does not regularly lend itself to continuous processes. That said, the use of novel science and technologies for continuous manufacturing can also lead to innovative pharma and biotech products and help pharma companies resolve some long-standing cost, quality inspection, and supply chain issues.
Well over a decade ago, the pharma and biotech industry started looking at producing products in continuous processes, rather than in batches. While most industry participants agreed that for high-volume, high-demand specialty drugs produced chemically in batches, the move from batch to continuous processing could work well. However, this doesn’t necessarily apply to biologics, which have very specific requirements.
Earlier this year, the European Medicines Agency and the US Food & Drug Administration (FDA) gave their approvals to Janssen Pharma and Novartis, respectively, to manufacture certain products in continuous processes. Janssen, a division of Johnson & Johnson, received FDA’s first approval to produce a drug to treat HIV (Prezista) in April 2016. Novar-tis is working with the Massachusetts Institute of Technology (MIT) to build a GMP continuous manufacturing facility.
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Keywords: Pharma, Biotech, Batch Processing, Continuous Processing, Innovation, ARC Advisory Group.