Pharmatech Associates has entered into a strategic alliance with the U.S. Pharmacopeia (USP) that brings pharmaceutical continuous manufacturing (PCM) expertise and capabilities to the marketplace to tackle drug shortages and supply chain issues by providing drug sponsors and manufacturers a more effective means of making finished drug products in the face of downward pricing pressure.

With Integra CMS a collaboration partner, Pharmatech Associates will provide a complete package of services and a proven roadmap for success to address the technical and experiential gaps, training, compliance, and regulatory needs of any drug sponsor or manufacturer making the switch from batch to PCM.

“Given our expertise and experience with PCM, the alliance of USP, Pharmatech, and Integra will bridge the knowledge gap and lower the perceived barriers to adoption and implementation to allow drug sponsors and manufacturers to realize the benefits of PCM,” said Bikash Chatterjee, Pharmatech Associates CEO.

Lawrence De Belder, Pharmatech Associates PCM practice lead said: “Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product lifecycle. It will help to improve control and process understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, tech transfer, and operational cost.”

“Continuous Manufacturing is the first major implementation of advanced manufacturing in the pharmaceutical industry. Instead of using traditional batch methods that are time-consuming and costly, product is continuously manufactured in a state of automated control,” said Fernando Muzzio, Integra CMS President.

USP’s focus on reducing barriers to PCM adoption is part of a broad range of activities designed to bolster medicine supply chain resilience.