Catalent and AstraZeneca have signed an agreement under which the former's subsidiary Catalent Cell & Gene Therapy will offer drug substance manufacturing to the investigational Covid-19 vaccine AZD1222 in the US.
The manufacturing of the AZD1222 vaccine candidate will be taken up at Catalent’s commercial gene therapy manufacturing plant in Harmans, Maryland.
Catalent said that it will prepare the Harmans manufacturing facility to enable various production trains to be operated parallelly to produce the vaccine candidate drug substance, starting from the third quarter of this year.
The agreement is an expansion of a similar agreement between Catalent and AstraZeneca in June under which the former’s facility in Anagni, Italy, will offer large-scale vial filling and packaging of the Covid-19 vaccine candidate.
Catalent Cell & Gene Therapy president Manja Boerman said: “Catalent has significant experience in viral vector manufacturing.
“We are pleased to have the capabilities at our flagship Catalent Gene Therapy site to expand our support for the AstraZeneca program, while continuing to serve our current gene therapy customers. Our gene therapy team is proud to join our Catalent Biologics colleagues at the Anagni site in the advancement of AstraZeneca’s COVID-19 vaccine candidate.”
Earlier this month, AstraZeneca concluded a deal with the European Commission (EC) to deliver up to 400 million doses of the investigational vaccine, which it had licensed from the UK-based Oxford University.
AstraZeneca also has supply deals with Russia, Japan, South Korea, China, Latin America, and Brazil for the vaccine candidate. The pharma major has a commitment to supply nearly three billion doses of the Covid-19 vaccine already.
In July, AstraZeneca reported that the AZD1222 vaccine candidate had produced strong immune responses against the Covid-19 causing SARS-CoV-2 virus in all participants in the COV001 study, which is a phase I/II trial.
Prior to that, in May, Oxford University launched a phase 2/3 trial of the Covid-19 vaccine candidate in the UK in almost 10,000 adult volunteers. The vaccine candidate was jointly invented by the university alongside Vaccitech, its spin-out company.