In this week’s news, USP wants input on mRNA product quality, US FDA finalizes drug recall guidelines and more.

USP wants industry input on mRNA drug and vaccine quality guidelines

The US Pharmacopeia (USP) is seeking scientific input on new draft guidelines on mRNA vaccine quality.

The independent scientific organization called for comment this week, explaining there is a need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines.

USP chief science officer, Jaap Venema, said, “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.” 

“The quality of mRNA products must be a top priority in order to facilitate market entry and build patient and provider trust.” 

Drug firms need a “recall ready” approach says US FDA

The US FDA says companies should be “recall ready” in new final guidance on voluntary product withdrawals.

The regulator made the suggestion this week, telling the drug industry that the rapid removal of drug product from the market is the best way to protect public health and preparation is required. 

Agency associate commissioner of regulatory affairs, Judith McMeekin, said “It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain.”

The new guidelines – available here – explain how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions. It encourages companies to use electronic communications to quickly provide product information when alerting the public about a voluntary recall. 

 

Also in the news

The drug industry still needs more information on US FDA plans for increased use of remote manufacturing facility inspections, according to a report by the Pink Sheet.

US President, Joe Biden, outlined plans to revitalize manufacturing in the country. One aim is to increase local production of drugs and APIs, reducing reliance on imports.

Bioprocess Insider looked at Andelyn’s calls for greater regulatory clarity on cell and gene therapy manufacturing.

 

CDMO trends

Some developments of note in the contracting sector:

Catalent’s incoming CEO has outlined his plans for the CDMO. Advanced therapies are likely to be a major focus in the coming years, according to a report by Bioprocess Insider.

Thermo Fisher Scientific has appointed Ruby Chandy, ex-resident of the Industrial Division of Pall Corporation (a leading supplier of filtration, separation and purification technologies), to its executive board.

The Center for Breakthrough Medicines (CBM) has entered into an agreement with BioAnalysis LLC (BIA). Under the deal, BIA will provide CBM’s clients with advanced testing services, including vector characterization.

Valneva says its subsidiary, Valneva Scotland, has been awarded research and development funding of up to £20 million by Scottish Enterprise to advance production of its COVID-19 vaccine candidates.

Investment firm Capri EGM has acquired a newly constructed R&D facility for US CDMO, National Resilience.