As it prepares to advance its COVID-19 vaccine candidate, J&J has contracted CDMO Emergent Biosolutions and reserved large-scale capacity at its site in Maryland.
In its efforts to tackle the novel coronavirus (SARS-CoV-2), Johnson & Johnson (J&J) began working on a vaccine candidate in early January and last month identified a lead COVID-19 vaccine candidate and two backups.
To prepare for trials and future approval, the firm has inked a deal with contract development and manufacturing organization (CDMO) Emergent BioSolutions valued at $135 million (‚ā¨125 million).
Emergent will provide drug substance manufacturing services beginning later this year, and will reserve large-scale manufacturing capacity to pave the way for commercial manufacturing of the adenovirus-based COVID-19 vaccine, expected to begin in 2021.
The vaccine candidate uses J&J division Janssen‚Äôs AdVac viral vector and PER.C6 cell line technologies, which has a proven safety profile having been used to develop and manufacture Ebola, Zika, RSV and HIV vaccine candidates.
The large-scale manufacturing of drug substance will be done at Emergent‚Äôs Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM), which is equipped with single-use bioreactor systems of up to 4,000 L, supplied by ABEC.
J&J has been vocal on its desire to build its manufacturing capacity up, and the added Emergent capacity will help reach the goal of one billion doses of its COVID-19 vaccine.
‚ÄúWe 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,‚ÄĚ Emergent‚Äôs SVP Syed Husain said in a statement.
Currently, J&J has the capacity to produce up to 300 million doses from its facility in Leiden, The Netherlands. In parallel, the firm has laid plans to utilize and expand its capabilities in Pennsylvania.
This is the second COVID-19 vaccine Emergent has been charged to produce, having been contracted in March to make a candidate for Novavax based on Novavax‚Äôs recombinant protein nanoparticle platform and Matrix-M adjuvant technology.