Novo Nordisk/AstraZeneca's Manufacturing Partner Thermo Fisher Questioned Over Manufacturing Lapses

Thermo Fisher Scientific’s TMO one of the largest contract drug manufacturing sites in the U.S., has repeatedly been flagged for regulatory violations.

Thermo Fisher’s Greenville facility manufactures around 40 medicines, including Novo Nordisk A/S’ NVO weight-loss drug Wegovy (semaglutide).

Recently, Stephen’s analyst said that Thermo Fisher’s pharma services assets, especially its contract development and manufacturing organization (CDMO), are well positioned. The company is set to capitalize on growth opportunities in the injectables sector, driven by GLP-1 demand and biologics drug substance production.

Over the past decade, the Greenville plant has been cited for issues related to contamination prevention, including two incidents earlier this year, Reuters noted, citing FDA documents.

Also Read: Thermo Fisher Q2 Earnings: Marginal Revenue Dip, Completes Olink Acquisition, Lifts Annual Profit Outlook.

Despite these concerns, the FDA did not take regulatory action, stating that the issues had been resolved to its satisfaction and that there was no evidence that patients had been harmed as a result.

During a recent inspection in May, the FDA identified manufacturing problems with Sanofi SA SNY and AstraZeneca Plc’s AZN Beyfortus. The respiratory syncytial virus (RSV) preventive drug for infants and toddlers scored FDA approval in 2023.

The Reuters report highlighted that the FDA identified 17 deficiencies during the Beyfortus audit, including insufficient visual inspections for particulate matter in injectable drugs and issues with staff handling of sterile components.

The agency noted that Thermo Fisher’s equipment sterilization procedures were inadequate, and visual inspections for injectable drug contaminants failed.

Thermo Fisher has since addressed these issues, providing the FDA with the necessary data on drug safety, including control over bubble size in injectable medications. However, experts remain concerned about the plant’s approach to quality control.

In July, Merck & Co Inc’s MRK Phase 2b/3 trial (MK-1654-004) of clesrovimab (MK-1654) to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints.

Price Action: TMO stock is down 0.39% at $598.59 during the premarket session at last check Friday.

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