AstraZeneca’s AZD1222 is one of several candidates supported by Operation Warp Speed (OWS), the U.S. government’s program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021. As part of OWS, Emergent will provide development and manufacturing services and capacity to innovators of leading COVID-19 vaccine candidates selected by the U.S. government, such as AstraZeneca.
“By partnering with leading innovators like AstraZeneca, Emergent is playing a critical role in increasing the world’s chances of having a safe and effective COVID-19 vaccine,” said Robert G. Kramer Sr., president and chief executive officer, Emergent BioSolutions. “We are proud to provide our CDMO services to advance AstraZeneca’s COVID-19 vaccine candidate. With this agreement, we bring to our facilities two of the five leading candidates being developed with U.S. government funding."
Under the agreement, valued at approximately $87 million, Emergent will provide development services, technology transfer, analytical testing, drug substance process and performance qualification and will reserve certain large-scale manufacturing capacity through 2020.
“As both a manufacturer of our own vaccines and a service provider, Emergent is uniquely equipped to take on the integral role of development and manufacturing partner to companies like AstraZeneca with lead vaccine candidates for COVID-19,” said Syed T. Husain, senior vice president and CDMO business unit head, Emergent. “We have spent decades establishing a strong, integrated CDMO network that allows us to dependably and consistently produce life-saving medicines for our company and for others worldwide.”
Development services will be provided out of Emergent’s Gaithersburg product development facility. Large-scale manufacturing of drug substance will be done at the Baltimore Bayview facility, an HHS-designated Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.
Emergent’s Bayview facility has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. 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.