US Pharmacopeia Providing Support to COVID-19 Vaccine, Antiviral Drug Developers

The US Pharmacopeia (USP) is providing free technical assistance to developers of antiviral drugs and vaccines that will support the public health response to the coronavirus disease 2019 (COVID-19) pandemic.

The scientific teams will be available to help developers ensure the quality of their materials as they scale up manufacturing to bring products into the clinical environment and design tests that guarantee high quality materials.

“A global pandemic requires ‘all hands-on deck’ and that includes USP,” said Jaap Venema, USP chief science officer, in an email to Pharmacy Times®. “Our staff and expert volunteers have expedited measures to address COVID-19 needs that span the length of the supply chain, from development to delivery of medicines. This includes facilitating the development of effective vaccines and antiviral medicines by providing free technical support to manufacturers looking to scale up manufacturing to bring products into the clinical environment as well as to design tests that ensure the quality of these emerging treatments.”

In addition, USP is ensuring that standards, training, and testing for manufacturers of critical medicines will continue to be available, as well as regulatory agencies to prevent potential drug shortages and protect the global supply of quality medicines for all.

“In support of those compounding sterile preparations, we have released a guidance on prioritizing the conservation and use of garb and personal protective equipment,” Venema said in an email to Pharmacy Times®. “USP has also provided a guidance on the compounding of alcohol-based sanitizers which are also in short supply.”

As an independent scientific organization committed to advocating for quality medicines, Venema said that USP is constantly looking for ways to prepare for future shocks to the supply chain that could be triggered by COVID-19.

“USP COVID-19 response efforts are part of our mission to promote public health, strengthen the integrity of the global medicines supply chain, and protect healthcare workers and patients,” Venema said in an email to Pharmacy Times®. “We are advocating for greater transparency in the global supply chain so health system stakeholders can better assess their risks and for policy reforms that will advance a more resilient supply chain.”

REFERENCE

U.S. Pharmacopeia (USP) Offers Support for Developers of COVID-19 Antiviral Drugs and Vaccines [news release]. Rockville, MD; PR Newswire: March 18, 2020. https://prnmedia.prnewswire.com/news-releases/us-pharmacopeia-usp-offers-support-for-developers-of-covid-19-antiviral-drugs-and-vaccines-301026446.html. Accessed March 23, 2020.