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USP Offers Support for COVID-19 Antiviral/Vax Developers

Aims to help developers ensure quality of their materials as they scale up manufacturing to bring products into clinical development.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The U.S. Pharmacopeia (USP) is providing free technical assistance to drug and vaccine developers to support the public health response to the COVID-19 pandemic.

USP scientific teams will be available to help developers ensure the quality of their materials as they scale up manufacturing to bring products into clinical development. USP is extending the support to manufacturers of treatments for secondary implications of the outbreak such as bacterial infections, to help facilitate a greater supply of these medicines.

USP will work with a stakeholder point of contact to facilitate solutions to address the pandemic. 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. 

USP is also making many of its standards more widely available. A selection of published standards (monographs and General Chapters) are available for free. More details about these resources can be obtained from the contact above.

 

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