Learn more about USP's COVID vaccine efforts:

To build public trust and confidence in innovative technologies, they must be of good quality, safe and effective. To address the need for a common set of methods for determining quality for viral vectored vaccines, USP is developing a set of analytical methods to support developers, manufacturers, regulatory agencies and national control laboratories worldwide. A shared understanding of viral vectored vaccine quality can help accelerate product development, guide successful scale-up of manufacturing and fuel regulatory confidence that manufacturers are employing best practices and appropriate quality controls when using this new modality.

USP welcomes public comments on Analytical Procedures for Viral Vectored Vaccines Quality.

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Read and review the draft guidelines

Submit your comments to USPVaccines@usp.org

USP Vaccine Quality Draft Guidelines

Analytical Procedures for Viral Vectored Vaccine Quality

To advance these draft guidelines, we call on industry, academic and government experts with experience or interest in viral vectored vaccines and technology to provide feedback on the methods detailed in these draft guidelines and recommend additional information to support the understanding of quality for viral vectored therapies. Submission of any alternative analytical methods as well as supporting documents (e.g., validation documentation) is encouraged.

Deadline for feedback is July 31, 2022

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