Diane McCarthy, director of biologics pipeline development at US Pharmacopeia (USP), discusses USP’s development of mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.
Pharmacy Times interviewed Diane McCarthy, director of biologics pipeline development at US Pharmacopeia (USP), to discuss USP’s development of mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.
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 mRNA vaccines and therapies. Because of 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 USP is requesting feedback from industry, academic, and government experts with experience or interest in mRNA vaccines and technology. For the purposes of the advancement of the draft, McCarthy explained that feedback on methods and recommended additional information to support understanding of mRNA quality are most advantageous.
“We're really looking for very broad feedback. We certainly would like to get feedback on these methods from developers of mRNA technologies, manufacturers, contract manufacturers, even many of the vendors that are making the technologies that are used to assess them can have input on this, as well as of course regulators and national control labs in particular,” McCarthy said. “We really are hoping that from industry, they may have some alternative methods that they would like to propose as well as potentially providing some validation packages that would help support eventually turning these into an official standard.”
Additionally, McCarthy noted that these standards are also intended to help in the process of building public trust in the safety and efficacy of this more recent vaccine technology. For that purpose, pharmacists are specifically beneficial as a source of insight on the questions patients ask regarding vaccine safety and quality.
“Pharmacists are engaging with patients every day. You're hearing the questions from patients in terms of questions around mRNA quality, and you may have questions yourselves,” McCarthy said. “We certainly would love to get feedback from pharmacists to understand how we can really help support quality and help support the public trust in these vaccines.
Following receipt of feedback from experts in the field, USP will present the draft guidelines at the World Vaccine Congress in March. For more information, visit usp.org/mrna-quality.