May 14, 2020 PR-M05-20-NI-020
Rockville, MD — To accelerate the development of safe and effective COVID-19 vaccines, medicines and other treatments, the U.S. Pharmacopeia (USP) has launched a new program to support scientists, developers and manufacturers worldwide. In response to overwhelming demand, with 2,000 downloads of select COVID-related USP standards made available in March, Trust Accelerated offers expanded access to free USP technical expertise and resources to support an efficient path for regulatory predictability, saving developers time and resources. Designed to expedite efforts to bring life-saving vaccines and treatments to market while ensuring quality development, the program builds the confidence and trust of healthcare practitioners and patients necessary for wide-scale adoption.
From discovery research and development through manufacturing and distribution, USP staff can advise on novel vaccines, monoclonal therapies, antiviral and cell therapies, and immunoglobulins or convalescent plasma treatments. Additionally, USP can support scaling up production of approved therapeutics being investigated or used for the treatment of COVID-19.
“Overcoming the COVID-19 pandemic will require rapid development of safe and effective treatments—in particular a vaccine—and ensuring their availability at sufficient scale,” said Jaap Venema, USP executive vice president and chief science officer. “Whether working on a new medicine or scaling up production of an approved therapeutic, recognizing and addressing quality challenges early in the complex research and development process are critical to accelerating any drug development program.”
The program is valuable for:
Testing and compliance to the standards detailed within compendial methods are fundamental requirements for manufacturing release and distribution of vaccines and medicinal treatments around the world. USP compendial tests and methods address common issues, such as suitability, validation, contamination control, stability testing and qualification of raw materials, shared by all drug manufacturers.
Groups ranging from small to midsize organizations—including biotech, university and government labs—to large manufacturers of biopharmaceuticals can leverage USP’s expertise as they work quickly to develop COVID-19 therapeutics and obtain regulatory approval.
Available resources include the following:
Additionally, USP scientific staff can help troubleshoot many quality-related challenges commonly encountered during development and scale-up, ultimately supporting manufacturers as they advance their strategies to manage regulatory and compendial expectations.
Our experts have years of experience evaluating a wide range of analytical problems and utilizing validated tests and procedures. These include tests for stability, sterility, extractables and leachables, dissolution, etc. that are required for regulatory approval. We can advise on:
USP is also working to connect companies seeking to collaborate with one another on quality issues and share sourcing of critical reagents. Contact USPBiologics@usp.org for technical assistance or more information.
Visit www.usp.org/covid-19 for more information about USP’s COVID-19 response, including supporting front-line workers impacted by shortages of critical drugs and personal protection equipment and helping to build a more resilient global medicines supply chain.
Media Contact
Anne Bell: adb@usp.org
Office: +1-301-998-6785
Mobile: +1-240-701-3242
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are enforceable in the United States by the Food and Drug Administration and integrated into law in more than 40 countries. These standards, which are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia, are also used in more than 150 countries.