AstraZeneca ropes in Catalent gene therapy site to produce viral vectors for COVID-19 vaccine

In the hunt for a novel coronavirus vaccine, British drugmaker AstraZeneca has raced to the front of the pack with promising interim data and a slew of proposed supply deals. One of its earliest partners in the effort, New Jersey CDMO Catalent, is now adding to its responsibilities as the vaccine nears regulatory scrutiny.

AstraZeneca and Catalent have fleshed out their manufacturing deal for the University of Oxford's adenovirus-based COVID-19 vaccine to include drug substance production, including viral vectors, at the CDMO's gene therapy facility in Harmans, Maryland, the partners said Monday.

Catalent will start production there in the third quarter, building on its previous pact with AstraZeneca for fill-finish and packaging duties at its Anagni, Italy, site.

The Harmans facility is in the vicinity of the Baltimore/Washington International Thurgood Marshall Airport—nearby air transport is common among commercial gene therapy manufacturing sites—and includes 20,000 square feet of commercial and clinical capacity. The facility is one of five gene therapy sites Catalent operates in Maryland and holds multiple CGMP manufacturing suites, including fill-finish, testing, warehousing and supply chain capabilities.

Catalent's work will include production of viral vectors for a genetically modified form of the adenovirus used in Oxford's shot, dubbed AZD1222. The modified virus, known as ChAdOx1 nCoV-19, aims to induce a lasting immune response to spike proteins added to the virus's surface.

On AstraZeneca's side, the newest deal comes as the drugmaker looks to boost production and distribution of the Oxford vaccine, which has emerged as a front-runner in the global pursuit for an effective COVID-19 shot.

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In June, AstraZeneca and Catalent reached a deal for finishing duties at the CDMO's Italian site, pledging to produce "hundreds of millions of doses" between this month and March 2022.

Catalent pledged space at its 305,000-square-foot manufacturing facility in Anagni through 2022 if AstraZeneca secured global regulatory approval. The vaccine is currently in phase 2/3 human testing in Brazil and the U.K.

The Anagni plant is busy, what with Catalent expanding a separate fill-finish and packaging deal for Johnson & Johnson's COVID-19 vaccine at the site in July. The partners previously agreed to reserve fill-finish capacity at Catalent's Bloomington, Indiana, plant.

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As part of their agreement, Catalent pledged to hire an additional 300 workers at the Bloomington plant starting in July, with the goal of reaching 24/7 manufacturing schedules by January.

Since AstraZeneca and Catalent initially agreed to work together, the British drugmaker has been hard at work inking expansive distribution deals to get its vaccine in as many hands as possible if regulatory approvals eventually come through.

Earlier this month, AstraZeneca and the European Commission reached a supply deal for 400 million doses of AZD1222, which will be supplied at no profit, the company said. That deal builds on a previous agreement with the Inclusive Vaccines Alliance, which is led by Germany, France, Italy and the Netherlands.

RELATED: Busy AstraZeneca inks yet another big COVID-19 vaccine deal, this time with EU

All told, AstraZeneca is working to bump its total vaccine supply per year to more than 3 billion doses through its network of contract manufacturers, national licensing deals and direct supply pacts.

The drugmaker had previously inked individual deals to supply Russia, South Korea, Japan, China, Latin America and Brazil. In the U.S., AstraZeneca has signed deals with contract manufacturers working with the Trump administration's Warp Speed initiative to scale up production but has yet to nail down a specific national supply agreement.

In July, AstraZeneca and Maryland-based Emergent BioSolutions reached a $174 million deal to produce bulk drug substance for AZD1222. That pact followed a separate $87 million deal in June to reserve commercial capacity at one of Emergent's sites.

Though the U.S. doesn't yet have a supply deal with AZ, the federal government did pledge $1.2 billion to help fund development of AZD1222 back in May. Along with the U.K., which also chipped in on development costs, the U.S. will likely see some of the first batches of the vaccine if it passes regulatory muster, AstraZeneca has said.