Pharmaceutical continuous manufacturing
A strategic alliance between USP and the Phlow Corp. to develop a new cutting-edge laboratory will certify and validate pharmaceutical continuous manufacturing (PCM) processes resulting in affordable, high-quality, U.S.-manufactured medicines. The methods developed through this work will be available for use by other generics manufacturers to encourage broader PCM adoption in order to strengthen the U.S. and global medicines supply.
“When crises such as natural disasters, geopolitical strife including barriers to trade and pandemics like COVID-19 arise, major interruptions in the global supply of quality medicines have an impact on American patients. PCM provides the availability and use of real-time data to accelerate manufacturing scale-up and help improve medicine quality, enabling more efficient and nimble production of essential medicines and strengthening the overall supply chain.”
- Ronald T. Piervincenzi, USP CEO
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Policy considerations to help harness pharmaceutical continuous manufacturing
USP’s new white paper reviews three challenges and proposes policy concepts to help accelerate the scientific and technical knowledge needed for broader adoption of PCM.