USP requires feedback from pharmacists to advance mRNA quality guidelines

USP requires feedback from pharmacists to advance mRNA quality guidelines

Pharmacy times interviewed Diane McCarthy, director of biological product pipeline development at US Pharmacopeia (USP), to discuss the USP’s development of mRNA quality guidelines to help companies and regulators enter the market innovative drugs more rapidly.

During the discussion, McCarthy explained that for the development of these guidelines, the organization is seeking scientific input for analytical procedures and best practices to help establish effective quality assessments for vaccines and mRNA therapies. Due to the relatively new successful application of this technology, regulatory guidelines and industry standards will continue to advance as the technology and its applications evolve.

Specifically, McCarthy noted that the USP is requesting feedback from industry, academic and government experts with experience or interest in vaccines and mRNA technology. For the purposes of advancing the draft, McCarthy explained that method feedback and additional information recommended to support understanding mRNA quality are the most beneficial.

“We are really looking for very broad feedback. Certainly we would like to receive feedback on these methods from mRNA technology developers, manufacturers, contract manufacturers, even many of the suppliers who are making the technologies used to evaluate them may have input on this, as well as of course regulators and in particular the national control laboratories. ” McCarthy said. “We really hope that the industry will have some alternative methods they would like to propose as well as potentially providing some validation packages that would help support the transformation of these into an official standard.”

Additionally, McCarthy noted that these standards are also intended to aid in the process of building public confidence in the safety and efficacy of this latest vaccine technology. To this end, pharmacists are particularly useful as a source of information on the questions patients ask about vaccine safety and quality.

“Pharmacists interact with patients every day. You are listening to patient questions in terms of mRNA quality questions and you may have questions too, “McCarthy said.” We would certainly like to hear feedback from pharmacists to understand how we can really help support quality and help support public confidence in these vaccines.

After receiving feedback from industry experts, USP will present the draft guidelines to the World Vaccine Congress in March. For more information, visit


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