Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has signed an agreement with AstraZeneca to provide CDMO services for large-scale commercial drug-substance manufacturing through 2021 for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, in a deal valued at approximately $174 million.

Emergent will provide the CDMO services beginning in 2020 to produce drug substance at large scale for commercial supply. The commercial pact follows an $87-million contract signed by the companies last month (June 2020) for CDMO services to support manufacturing of AstraZeneca’s COVID-19 vaccine candidate with development services, performance and process qualification, raw materials, and an initial capacity reservation.

The adenovirus vector-based vaccine candidate, AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. The vaccine candidate is in clinical trials and is one of the candidates funded and supported by Operation Warp Speed, a US government program that aims to accelerate the development of COVID-19 treatments and vaccines.

This agreement follows and is in addition to the public–private CDMO partnership between Emergent and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), announced last month (June 2020). That task order, valued at $628 million, is for domestic production through 2021 of COVID-19 vaccine candidates. Under that task order, Emergent is providing CDMO services and manufacturing capacity for $542.7 million, and BARDA is providing approximately $85.5 million to expand Emergent’s viral and non-viral drug product fill–finish capacity.

Under its task order with BARDA, Emergent will provide commercial manufacturing at its Baltimore Bayview facility, which is a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the HHS, and is designed for manufacturing of large quantities of vaccines and treatments during public health emergencies. The CIADM has capabilities across four independent suites to produce at clinical scale and large-scale manufacturing to up to 4,000 L. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis based upon the platform technology being used.

Source: Emergent BioSolutions