COVID Vaccines Demonstrated the Potential of mRNA Technology but Common Approaches for Managing Quality are Needed

Rockville, Maryland, February 23, 2022 / PRNewswire / – The US Pharmacopoeia (USP), a global independent scientific organization, is looking for a scientific contribution to a new draft guideline “Analytical Procedures for the Quality of mRNA Vaccines”. The USP and a team of leading mRNA experts have identified the need for analytical procedures and best practices to support the assessment of mRNA vaccine quality and treatments in the development of infectious diseases, cancer, cystic fibrosis and other diseases.

To strengthen public confidence and confidence in innovative products such as mRNA therapy, they must be high quality, safe and effective. As the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach to mRNA quality assessment supports developers, manufacturers, regulatory authorities and national control laboratories around the world, and provides tools to help accelerate the development of safe and effective mRNA-based products.

“We have all witnessed the first successful use of mRNA technology in the global fight against COVID-19, and we are very optimistic that mRNA technology is being applied to treatments and vaccines for a variety of conditions. The quality of mRNA products should be a top priority to facilitate market entry and build the trust of patients and suppliers. ” said Jaap Venema, Ph.D., Executive Vice President and Chief Research Fellow, USP. “USP brings together industry and research experts in new technology fields to identify best practices for understanding quality as this technology continues to grow. Without this common understanding, manufacturers must develop their own techniques, diverting attention and resources from the successful application of this technology.”

Since the beginning of the pandemic, USP resources have helped reassure stakeholders that mRNA vaccines – and other vaccine platforms – are produced, distributed and managed efficiently and effectively, providing quality management tools across the supply chain from best manufacturing practices to supporting frontline health workers. governing them. The following resources are currently available:

  • Tools for working with vaccines against COVID-19
  • International Guidelines for the Treatment of COVID-19 Vaccines
  • Maximum doses for Pfizer and Moderna
  • Information on vaccines against COVID-19 that did not relate to the date of use
  • COVID-19 Vaccine Transportation Guide
  • Vaccine quality attribute toolkits

To promote the draft guidelines, the USP appeals to industry, scientific, and government experts with experience or interest in mRNA vaccines and technologies to provide feedback on methods and recommend additional information to understand mRNA quality. Initial feedback on this project will be presented by the USP at the World Vaccine Congress in March. For more information, visit usp.org/mrna-quality.

About USP

USP is an independent research organization that collaborates with the world’s leading experts in health and science to develop quality resources and standards for drugs, dietary supplements and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food to billions of people around the world. For more information, visit www.usp.org.

Media contact: Anne Bell240-701-3242, [email protected]

SOURCE US Pharmacopoeia

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