Rockville, MD, July 11, 2023 – The U.S. Pharmacopeia (USP) and The National Institute for Pharmaceutical Technology and Education (NIPTE) today announced the official launch of their jointly-developed Continuous Manufacturing Knowledge Center (CMKC). The online platform is designed to provide drug developers, manufacturers, regulatory bodies, academia, and other stakeholders across the medicines supply chain with rapid access to the latest, updated information to facilitate innovation and help identify and address barriers to adoption of pharmaceutical continuous manufacturing (PCM).
“This centralized, digital information resource is now live, providing an easy-to-use, searchable database to capture, organize, and update rapidly expanding knowledge about PCM,” said Vadim J. Gurvich, Ph.D., MBA, Executive Director of NIPTE and Research Associate Professor at the University of Minnesota. “The CMKC also features an online community network with tools to facilitate collaboration and discussion among PCM experts on related, shared challenges and knowledge gaps.”
“The CMKC will support the efforts of drug makers seeking to adopt PCM as one way to unlock potential manufacturing efficiencies for many medicines and their ingredients, increase geographic diversity in pharmaceutical manufacturing, and support medicines supply chain resilience,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “While presenting potential advantages, adopting new technologies like PCM comes with challenges. The CMKC is among the latest resources from USP that can help fill the gap to facilitate market access to trusted, quality-assured medicines made with PCM.”
The free, online CMKC platform provides multiple opportunities for users to:
- Connect and collaborate with peers, professionals, and experts
- Ask about and explore solutions to common questions
- Share advances and experiences related to PCM
- Discuss economic and scientific challenges associated with PCM
- Reduce time and effort required to find PCM resources
- Share and upload resources
- Overcome challenges associated with new technology adoption
Developed through a collaboration with NIPTE announced in April 2022, the CMKC is supported in part by funding awarded to NIPTE by the U.S. Food and Drug Administration through a “Manufacturing Sector Research Initiative” grant. The result will organize information including research publications, industry practices, presentations at technical forums, non-peer-reviewed materials, and regulatory communications currently scattered across multiple platforms or otherwise not easily accessible. CMKC information will be curated into technical areas of interest and related discussion groups, including continuous manufacturing of API, continuous manufacturing of oral solid dosage forms, process analytical technologies (PAT), process control, process modeling, and regulatory science. Learn how the CMKC can help you find resources and connect with experts on PCM at https://cmkc.usp.org.
Technical Guide & Workshop
The CMKC is just the latest in a series of quality-focused solutions developed by USP to help identify and address the barriers to adoption of PCM. Others include a technical guide on development of control strategies for continuous manufacturing of solid oral dose drug products. In addition, USP is leading a workshop on identifying and addressing barriers to adoption of PCM on July 18-19, with a virtual option for those who cannot attend in person. Click here to learn more.
Pharmaceutical Continuous Manufacturing
PCM is an advanced manufacturing technology gaining increased attention from industry and policymakers for its potential to enable production efficiencies for many drugs and their ingredients. Such efficiencies can help achieve geographic diversity in sourcing and supply chain resilience. Obstacles to PCM adoption remain, however. These can include knowledge gaps, such as the areas where PCM use could be the most impactful, and how to best implement it.
PCM involves a continuous flow of materials through a process pipeline – in which two or more unit operations are directly connected – and the sequential transformation of those materials. The process output – such as an active pharmaceutical ingredient or drug product – is collected as the input materials are being fed in, and the entire process happens in a single facility. To learn more about PCM, watch the video here.
NIPTE is a non-profit academic organization that collaborates with industry, academia, and government to improve the way medicines are designed, developed, and manufactured to meet the needs of patients in the 21st century. It consists of Duquesne University, Illinois Institute of Technology, Long Island University, Purdue University, Rutgers University, Texas A&M University, University of Connecticut, University of Kansas, University of Kentucky, University of Maryland, University of Massachusetts, University of Michigan, University of Minnesota, University of Mississippi, University of Puerto Rico, University of Rochester, University of Texas at Austin, Virginia Commonwealth University, and the Indian Institute of Technology at Delhi. For more information, visit: www.nipte.org
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. This includes actively collaborating with academic research centers, industry and regulators to help advance PCM standardization efforts. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. For more information, visit: www.usp.org
USP: Jon Dobson
NIPTE: Lorri Chapman