Contract Pharma Staff07.06.20
Emergent BioSolutions has entered a five-year manufacturing services agreement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac technology. Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years.
“We are proud to deploy our manufacturing strength to address the COVID-19 pandemic,” said Robert G. Kramer Sr., president and chief executive officer, Emergent BioSolutions. “Advancing this collaboration is one of the ways we live our mission—to protect and enhance life.”
Under the agreement, Emergent will begin providing large-scale drug substance manufacturing for Johnson & Johnson’s adenovirus-based COVID-19 vaccine in 2021, upon successful completion of the activities under the previously executed Technology Transfer Agreement. For the subsequent years beginning 2023, Emergent will provide a flexible capacity deployment model to support additional drug substance batches annually.
“Over the next five years, we are committing our leading CDMO services to advance this important vaccine candidate,” said Syed T. Husain, senior vice president and CDMO business unit head, Emergent. “We have the expertise and capabilities to meet the long-term needs of our customers and provide ongoing commercial manufacturing to benefit patients.”
This long-term large-scale manufacturing agreement follows and is incremental to the contract announced in April for drug substance manufacturing technology transfer services and for reserving certain large-scale manufacturing capacity to pave the way for commercial drug substance manufacturing for the COVID-19 vaccine candidate.
Activities will be performed at Emergent’s Baltimore Bayview facility, a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS), 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.
“We are proud to deploy our manufacturing strength to address the COVID-19 pandemic,” said Robert G. Kramer Sr., president and chief executive officer, Emergent BioSolutions. “Advancing this collaboration is one of the ways we live our mission—to protect and enhance life.”
Under the agreement, Emergent will begin providing large-scale drug substance manufacturing for Johnson & Johnson’s adenovirus-based COVID-19 vaccine in 2021, upon successful completion of the activities under the previously executed Technology Transfer Agreement. For the subsequent years beginning 2023, Emergent will provide a flexible capacity deployment model to support additional drug substance batches annually.
“Over the next five years, we are committing our leading CDMO services to advance this important vaccine candidate,” said Syed T. Husain, senior vice president and CDMO business unit head, Emergent. “We have the expertise and capabilities to meet the long-term needs of our customers and provide ongoing commercial manufacturing to benefit patients.”
This long-term large-scale manufacturing agreement follows and is incremental to the contract announced in April for drug substance manufacturing technology transfer services and for reserving certain large-scale manufacturing capacity to pave the way for commercial drug substance manufacturing for the COVID-19 vaccine candidate.
Activities will be performed at Emergent’s Baltimore Bayview facility, a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS), 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.
