Thermo Fisher Scientific is responsible for helping to produce some of the hottest drugs on the market, including Novo Nordisk’s obesity blockbuster Wegovy and Sanofi and AstraZeneca’s infant respiratory syncytial virus (RSV) antibody Beyfortus. But according to the FDA, problems were stacking up at the company’s Greenville, North Carolina, plant earlier this year.
The agency inspected the company’s site, which belongs to its Patheon CDMO subsidiary, in May. The 1.5 million-square-foot plant offers sterile dose manufacturing and filling, among other capabilities, and boasts more than 1,500 employees.
According to Reuters, the inspection was part of a larger, now-resolved Thermo Fisher audit relating to the manufacturing of Beyfortus.
"As the commercial lead for Beyfortus, we emphasize that all findings were addressed, reviewed by the regulator, and Beyfortus doses were approved by the FDA prior to being released," Sanofi told Fierce Pharma in an emailed statement. "As always, the safety and quality of our products remains our highest priority."
During the agency's visit, the FDA identified several issues across multiple areas. For one, the facility had problems with some of its production procedures, one of which relates to monitoring and measuring air bubbles inside syringes, according to FDA documents reviewed by Fierce Pharma.
“Your sampling plan for bubble size do not result in statistical confidence in your process performance,” the inspectors wrote in their report.
Furthermore, according to the report, some visual inspection processes weren’t up to par and used a timeframe not backed by studies, particularly in terms of ensuring that finished product is cleared of particulate matter.
Then, there were concerns with microbiological contamination of sterile drug products. Aspects of the products, including the stoppers, reportedly were not sterilized prior to assembly and in one instance made direct contact with a non-sterile glove. The FDA pointed out that since July 2022, the North Carolina plant had made approximately 35 glove integrity testing failures during filling operations, with six of them impacting undisclosed products. All but one batch of said product was released for commercial distribution, according to the document.
According to the agency, a lack of conclusions and follow-ups—which can include product impact assessments—in written records of investigations mean that in one case, there was no assurance that syringes with certain air bubble sizes were removed from commercial batches during the manufacturing process. There were also reportedly some deviations the company investigated but the definitive root causes of which weren’t identified.
Finally, the FDA found some red flags in the quality control unit relating to electronic data systems and metadata associated with batch records.
Beyfortus' launch was hampered by supply issues last year, prompting an amped-up manufacturing effort for the upcoming RSV season that includes a new filling line.
Thermo Fisher’s Greenville site also fills Wegovy injection pens after Novo tapped the manufacturer to help overcome its own shortage problems tied to FDA concerns at a Catalent plant.