J&J in Mfg Pacts with Emergent, Catalent for COVID Vaccine Candidate
The Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) have signed separate agreements with Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, and Catalent for the manufacturing of J&J’s investigational COVID-19 vaccine candidate.
The partnerships are designed to accelerate manufacturing of J&J’s COVID-19 vaccine candidate and to further J&J’s goal to supply more than one billion doses of the vaccine globally. J&J announced in March (March 2020) that it expects to initiate human clinical studies of its lead COVID-19 vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021.
Manufacturing pact with Emergent BioSolutions
Under the agreement with Emergent BioSolutions, valued at approximately $135 million, Emergent will provide drug-substance manufacturing services supported by investments from J&J beginning in 2020 and will reserve certain large-scale manufacturing capacity for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021. To support J&J’s goal of supplying one billion doses of a COVID-19 vaccine, a long-term commercial manufacturing agreement with Emergent BioSolutions is under negotiation for large-scale drug substance manufacturing anticipated to begin in 2021.
The large-scale manufacturing of drug substance for J&J’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 US Department of Health and Human Services.
J&J has already begun preparations for clinical vaccine production at its facility in Leiden, the Netherlands, with the aim of initiating Phase I human clinical studies of its vaccine candidate in September 2020. J&J will begin production at risk and says it is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. Simultaneously, J&J is also aiming to rapidly scale up vaccine-manufacturing capabilities globally, including increasing capacity in countries outside the US.
J&J’s manufacturing pact with Catalent
In a separate development, Catalent is partnering with J&J to accelerate availability of manufacturing capacity and prepare for large-scale commercial manufacturing at its facility in Bloomington, Indiana of J&J’s lead vaccine candidate for COVID-19.
The collaboration commits joint investment to accelerate rapid scale-up of segregated manufacturing capacity over the coming months (as reported on April 29, 2020) to support dedicated production of J&J’s investigational vaccine candidate. Catalent says it plans to hire approximately 300 additional employees at the site for this program starting in July 2020 to meet operational readiness and 24 × 7 manufacturing schedules by January 2021.
Catalent’s 875,000 square-foot facility in Bloomington, Indiana has capabilities for sterile formulation and drug-substance development and manufacturing and drug-product fill–finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging.