The New Jersey company said it will prepare its commercial gene therapy manufacturing facility in Harmans, Maryland, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains. These would run in parallel to produce the vaccine candidate drug substance, starting late in this year’s third quarter.

Catalent ‘s new agreement with the Anglo-Swedish drugmaker builds on an existing pact announced in June, which sees sister company  Catalent Biologics’ facility in Anagni, Italy, providing large-scale vial filling and packaging of AZD1222.

Co-invented by the University of Oxford and its spin-off Vaccitech, the vaccine candidate licensed to AstraZeneca earlier this year is currently in the final phase of global clinical trials that involve 30,000 people and are due to conclude by the end of 2020.

AstraZeneca already has signed vaccine supply deal or pledged to supply vaccine doses to almost all national and international buying blocs.

Catalent’s Harmans/BWI commercial manufacturing facility, one of its five gene therapy facilities in Maryland providing clinical through commercial scale services, is equipped with single-use technology and devotes 18,600 m2 of space to late-stage clinical and commercial-stage gene therapy production. Its multiple CGMP manufacturing suites include fill/finish, central services and testing laboratories and warehousing, along with supply chain capabilities.

The Catalent Biologics network also includes sterile drug product manufacturing and packaging facilities in Anagni, Italy, Brussels, Belgium, and Bloomington, Indiana, with additional facilities in Europe and the US for manufacturing proteins, cell therapies and biologics analytical services. The company touts its “significant experience” in viral vector manufacturing.

AstraZeneca taking antibody route, too

Alongside its vaccine development, AstraZeneca is working on antibody technologies to fight Covid-19.  In June, the drugmaker licensed six antibodies from Vanderbilt University Medical Center in the US state of Tennessee and outlined plans to start a clinical trial to evaluate a combination of two of them within two months.

The company has now started a phase 1 clinical trial of its two-antibody cocktail with 48 participants. This is set to deliver data later this year and put AstraZeneca in a position to evaluate the protective and therapeutic effect of the drug in larger phase 2 and 3 studies.

Antibody treatment is one strategy for dealing with the disease caused by the novel corona virus. It is thought that these could provide an extra layer of protection to vaccinated, high-risk individuals or serve as the sole defense of people who are ineligible for vaccination.

According to reports, AstraZeneca’s pursuit of an antibody timeline alongside its virus development track has put it slightly behind antibody font runners such as Eli Lilly and Regeneron, which are now in Phase 3 clinical trials.

Author: Dede Williams, Freelance Journalist