Batch production is time consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus shut down of equipment between “batches” is required, which eliminates down time. CM saves time and reduces the likelihood for human error, but is it realistic at this point in time? In this episode we cover the pros and cons in transitioning to a continuous manufacturing system.
Resources for this episode:
- FDA issued draft guidance, Quality Considerations for Continuous Manufacturing
- Rogers, Luke & Jensen, Klavs F. (2019). Continuous manufacturing – the Green Chemistry promise?. The Royal Society of Chemistry. Green Chem., Volume 21, 3481-3498.
- Moore, Christine M. V., Garcia, Thomas P., Hausner, Douglas B., Ben-Anat, Inna. (2019) Holistic Control Strategies for Continuous Manufacturing. Pharmaceutical Engineering, May/June 2019
- Srai, Jagjit Singh., Settani, Ettore., Aulakh, Parminder Kaur., Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network Perspective. Continuous Pharmaceutical Processing, June 2020, 477-512
- Van Arnum, Patricia. Pharma Industry Weighs in on Continuous Manufacturing. June 19, 2019
- Manning, Richard., Sciacca, Rich., Continuous Manufacturing in Pharmaceuticals: Economic and Policy Issues. Bates White Economic Consulting, October 2018