USP seeks input on mRNA analytical testing guide

Regulatory NewsRegulatory News
| 28 February 2022 | By Joanne S. Eglovitch 

The United States Pharmacopoeia (USP) has released a new draft chapter proposing a set of analytical procedures and best practices to accelerate product development and support quality assessments for mRNA-based vaccines and other therapies, such as treatments for cystic fibrosis and certain cancers.
USP and global stakeholders have “identified a need for analytical procedures and best practices to support the assessment of common quality attributes of mRNA vaccines,” according to an announcement.
“Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving,” said USP. “Without a common set of methods for determining quality, developers and manufacturers of mRNA products must develop their own in-house methods and protocols, taking attention and resources away from a company’s successful application of mRNA technology unique to the medical product.”
Jaap Venema, USP’s executive vice president and chief scientific officer said that ensuring mRNA quality must be a “top priority” to ease market entry of these products and build patient trust. “We all witnessed the first successful use of mRNA technology in the global fight against COVID-19, and we are very optimistic about the promise of mRNA technology applied to therapies and vaccines for a variety of conditions," he said. 
The quality of mRNA drug substances is determined by the design and the specifications used in the development and manufacturing process. The draft guideline lists a set of methods to assess the identity, content, integrity, purity and safety of the substance.
For example, for identity testing, USP proposes developers use one of the following methods: next generation sequencing (NGS), sanger sequencing or reverse transcriptase-PCR. To assess safety, developers should use testing methods outlined in USP chapters 85, 61, 62, 115 and 71.
The methods described in the guideline have been adopted from “publicly available” sources and were vetted USP’s scientific expert committee on biologics. The draft also incorporates best practices from two USP standards on vaccines: USP General Chapter 1235 “Vaccines for Human Use – General Considerations” and USP Chapter 1239 “Vaccines for Human Use – Viral Vaccines.”
USP said release of the draft is a “first step” towards developing a procedural chapter on testing mRNA vaccines.
Comments are being accepted until 31 May. USP encourages the submission of any alternate methods.
USP draft chapter
Press release


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