April 23, 2020: Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement whereby Emergent will deploy its contract development and manufacturing (CDMO) services to support the manufacturing of Johnson & Johnson’s lead vaccine candidate for COVID-19 that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson.
Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, stated, “When mission-driven organizations combine talents and capabilities, potential solutions to serious issues like COVID-19 become more within reach to benefit patients. We are proud of our collaboration with Johnson & Johnson and are equally committed to our longstanding relationship with the U.S. government. At a time like this, we all need to be working together to achieve maximum results for public health. Emergent is committed to our mission – to protect and enhance life – by advancing our own therapies and helping partner companies advance their programs as well.”
Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021.
To support Johnson & Johnson’s goal of supplying one billion doses of a COVID-19 vaccine, a long-term commercial manufacturing agreement is under negotiation for large-scale drug substance manufacturing anticipated to begin in 2021.
Large-scale manufacturing of drug substance for Johnson & Johnson’s vaccine candidate will be done at Emergent’s Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of vaccines and treatments in large quantities during public health emergencies. Emergent’s CIADM is a result of a public-private partnership with the U.S. Department of Health and Human Services (HHS).
“Eight years ago, HHS invested in novel public-private partnerships to create three Centers for Innovation in Advanced Development and Manufacturing or CIADMs to help strengthen the nation’s biotech infrastructure to prepare and respond to emergencies,” said Gary Disbrow, Ph.D., acting director of the Biomedical Advanced Research and Development Authority. “Leveraging the capacity available at the Bayview CIADM to speed development and manufacturing of COVID-19 vaccine is precisely how we envisioned these centers be used in pandemic response.”
Syed T. Husain, senior vice president and CDMO business unit head at Emergent, stated, “We share with our partners the same urgency to combat COVID-19 and will leverage our talents, capabilities, and capacities up to 300 million doses to advance this much-needed vaccine candidate and ensure ongoing commercial supply through our CDMO services.”
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.
