Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has signed a five-year manufacturing services agreement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), valued at approximately $480 million (for the first two years), for large-scale drug-substance manufacturing of J&J’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S (recombinant).

The production is based on J&J’s AdVac technology. The AdVac technology works by using an adenovirus as a vector (a carrier) of an antigen’s genetic code to mimic components of a pathogen (a bacterium, virus, or other disease-causing organism).

This long-term large-scale manufacturing agreement follows and is incremental to the companies’ contract announced in April (April 2020) for drug-substance manufacturing technology-transfer services and for reserving certain large-scale manufacturing capacity for commercial drug-substance manufacturing for the COVID-19 vaccine candidate.

Under the agreement, Emergent will begin providing large-scale drug-substance manufacturing for J&J’s adenovirus-based COVID-19 vaccine in 2021, upon successful completion of the activities under the companies’ previously executed technology-transfer agreement. For subsequent years beginning in 2023, Emergent will provide a flexible capacity-deployment model to support additional drug-substance batches annually.

Activities will be performed at Emergent’s Baltimore Bayview facility, a designated Center for Innovation in Advanced Development and Manufacturing by the US Department of Health and Human Services for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.

The Bayview facility has capabilities across four independent suites for clinical-scale production and scale-up to commercial volume. It 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.

J&J’s COVID vaccine candidate uses the company’s proprietary AdVac technology, which works by using an adenovirus as a vector (a carrier) of an antigen’s genetic code to mimic components of a pathogen (a bacterium, virus, or other disease-causing organism).

Source: Emergent BioSolutions