Production will take place at Catalent’s viral vector manufacturing facility located in Harmans, Maryland, which the company acquired in 2019 via its $1.2bm buy out of Paragon Bioservices.
The CDMO said it will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance.
The new agreement expands Catalent’s work in relation to the AZD1222 program following the announcement in June that it had been brought on board to provide vial filling and packaging capacity. Catalent’s site in Anagni, Italy is to cover that aspect of the vaccine's manufacture.
Efficacy of AZ vaccine candidate
Yesterday [August 31], AZ said that clinical development of AZD1222, which is a recombinant adenovirus vaccine technology created by the Jenner Institute at the University of Oxford, is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials also planned to start in Japan and Russia.
These evaluations, together with a newly announced US Phase III clinical trial, will enroll up to 50,000 participants globally.
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet. The company said those findings showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
Catalent chasing COVID-19 deals
With growing numbers of potential COVID vaccines and treatments emerging from large pharma and biotech alike, Catalent has steadily secured agreements in the space, commented David Windley, Jefferies US equity research - healthcare, pharmaceutical services - in a note published today on the company’s Q4 2020 financial results.
The CDMO, he noted, has signed over 50 deals, including work on J&J's, Moderna's, and AstraZeneca's lead vaccine candidates.
While it has developed relationships with notable biopharma clients on vaccine work, its biologics mix is growing faster than expected, which should continue with progress in COVID molecules, and its overall top-line growth is faster, said the analyst.
Catalent, said Windley, is notably supplementing all biologics related areas including bringing the fourth and fifth trains online in Madison, Wisconsin, developing its Limoges, France facility as a biologics center of excellence and adding suites at its Paragon gene therapy facility and capacity at its Bloomington, US site for COVID-19 therapy work.
As it attempts to ramp up its cell and gene therapy platforms in FY21, Catalent will incur operating costs such as onboarding and training staff that weigh on margin, said the Jefferies analyst. But once the CDMO has solidified the buildout of its platforms to accommodate the surging demand, he believes that the intrinsically higher margin in cell and gene therapy as well as improving the mix will enable faster margin expansion.