Catalent pauses work on unfinished UK biologics plant as it resolves regulatory woes

 Contract manufacturing major Catalent is pausing work at a plant in the U.K. as it overcomes regulatory problems at sites in Europe and the U.S.

After a recent dip in share price, Catalent elected to pause work on its biologics development and manufacturing facility near Oxford, U.K., The Times UK first reported. Catalent is cutting and delaying certain projects at the site as it contends with an expected slowdown in COVID-19 product revenue, which helped the CDMO raise its profile considerably over the past couple of years, according to the report.

Catalent picked up the Oxford site from the U.K.'s Vaccine Manufacturing and Innovation Centre (VMIC) back in April. In an email, a Catalent spokesperson told Fierce Pharma the company is indeed pausing development at Oxford, though it still intends for the site to become operational sometime after July 2023.

"To ensure that Catalent continues to operate efficiently and sustainably, the company has decided to reduce and delay some of its capital expenditure projects," the spokesperson said. "This includes temporarily suspending construction activities at our Oxford facility, which remains an important element of Catalent’s long-term growth plans in Europe."

The U.K. government put the Oxfordshire plant on the bidding table back in November 2021, looking to recoup about 215 million pounds (then some $287 million) in investments at the site. The U.K. initially rolled out plans for VMIC in 2018 in a bid to steel the country against future infectious disease outbreaks.

The British government idled work on the Vaccine Centre last year after the pharmaceutical industry stepped up during the COVID-19 pandemic to develop, produce and distribute vaccines.

Catalent then swooped in to purchase the partially built biologics facility this spring, at the time pledging $160 million to wrap up work at the site near the Harwell Science and Innovation Campus. When Catalent picked up the site in April, the company said the facility would eventually be used to develop and produce biologic therapies and vaccines based on mRNA, proteins and other advanced modalities.

Elsewhere, Catalent is faring better at plants in the U.S. and continental Europe, where the company has resolved separate FDA citations it received over the summer. Following the receipt of FDA Form 483s at its sites in Bloomington, Indiana, and Brussels, Belgium, the FDA has handed down a voluntary action indicated (VAI) response at both facilities, Endpoints News first reported.

That's a better outcome than an official action indicated tag, which indicates some sort of further regulatory action is likely—such as a warning letter—though still not as ideal as receiving no action indicated designation at a plant. 

The VAI tag "means the Agency considers Catalent’s response and proposed corrective actions sufficient such that no further regulatory action is required,” Catalent's spokesperson said of the FDA responses. He noted that the Bloomington site was able to keep operating throughout the inspection process.

For Catalent’s Belgian site—where the CDMO makes Novo Nordisk’s obesity blockbuster-in-waiting Wegovy—the FDA flagged problems with air filters in aseptic areas plus deficient changes to the HVAC system and other equipment-related issues. The write-up came after an inspection last October uncovered similar production flubs at Catalent’s syringe filling plant in Brussels.

The problems last year helped fuel supply difficulties for Novo Nordisk's obesity launch of Wegovy, which the Danish company aims to resolve before the year is out.

As for Bloomington, issues at that plant led to a delayed rollout of Moderna's updated COVID-19 vaccine this fall, according to various press reports.

https://www.fiercepharma.com/manufacturing/catalent-puts-kibosh-british-biologics-plant-where-it-planned-invest-160m-report