USP Offers Support for Developers of COVID-19 Antiviral Drugs and Vaccines

The U.S. Pharmacopeia (USP) is providing free technical assistance to developers of medical treatments such as antiviral drugs and vaccines that can support the public health response to the COVID-19 pandemic. USP is making its scientific teams available to help developers ensure the quality of their materials as they scale up manufacturing to bring products into the clinical environment as well as to design tests that ensure quality of materials. USP is extending the support to manufacturers of treatments for secondary implications of the outbreak (e.g. bacterial infections) to help facilitate a greater supply of these critical medicines.

We call on stakeholders to designate a point of contact from their organization with whom we can discuss how we will work as a community with the goal of creating an environment for enhanced information sharing and partnering to facilitate solutions to address the pandemic. USP will work with stakeholders developing viral testing strategies, antiviral therapies, and vaccines, as well as experts from global regulatory bodies and public health agencies (e.g., Centers of Disease Control, U.S. Food and Drug Administration, World Health Organization).

USP scientific teams are prepared to assist with solutions in numerous areas. Examples include:

• Best practices that are broadly applicable to manufacturing and testing strategies and are aligned with global regulatory guidelines; includes test methods and procedures (e.g., sterility testing, bacterial contamination control) that can be used to manage regulatory expectations;
• Qualification of excipients and raw materials to be used in manufacturing; 
• Our collection of USP Reference Standards which contain materials to demonstrate the suitability of the methods and can also be used for the development and validation of analytical methods;
• Technical assistance to those who are interested in following our processes and use our standards. We are happy to engage in further dialog with stakeholders to ensure that their approaches to analytical methods can meet compendial and regulatory expectations.

In addition to providing technical assistance, USP is making many of its standards more widely available. A selection of published standards (monographs and General Chapters) are available for free.

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