USP/Pharmatech to Provide Pharmaceutical Continuous Manufacturing Capabilities for Drug Developers and Manufacturers
In line with the U.S. Pharmacopeia (USP) initiative to support and guide industry adoption of pharmaceutical continuous manufacturing (PCM), Pharmatech Associates has reached an agreement with Integra CMS to provide additional development capability and expertise to assist the pharmaceutical industry in implementing PCM processes
HAYWARD, Calif.–(BUSINESS WIRE)– Pharmatech Associates today announced a strategic alliance that brings 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 Continuous Manufacturing Systems as its 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.
“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,” said Lawrence De Belder, Pharmatech Associates PCM Practice Lead.
“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 Dr. 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.
About Pharmatech Associates – a USP Company
Pharmatech Associates is a global consultancy for the life science industry that meets the complex needs of clients with highly experienced scientists and engineering subject matter experts. Pharmatech’s team specializes in Product and Process Development, Facilities and Capital Projects, Quality Compliance, and Regulatory Affairs. Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in Asia, Europe, and North America from its headquarters in the San Francisco Bay Area.
Learn more at www.pharmatechassociates.com.
About Integra Continuous Manufacturing Systems
Integra CMS, a subsidiary of Acumen Biopharma, is a New Jersey-based company pioneering continuous manufacturing processes for the wider drug industry. Founded in 2015 by Dr. Fernando Muzzio, in 2016 Integra CMS completed a comprehensive licensing agreement with Rutgers University to develop, practice, and commercialize advanced continuous manufacturing services, making them available and accessible to manufacturers on a wider scale.
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Judy Curtis—SIPR for Pharmatech
+ 1 650-274-1509