Emergent to produce drug substance for J&Js Covid-19 vaccine

Emergent BioSolutions has entered a five-year agreement with Johnson & Johnson unit Janssen Pharmaceutical for large-scale manufacturing of drug substance for the latter’s Covid-19 vaccine candidate, Ad26.COV2-S.

As part of the deal, Emergent agreed to offer contract development and manufacturing (CDMO) services for drug substance production, valued at about $480m for the initial two years.

The company will start delivering manufacturing services for the Ad26.COV2-S vaccine in 2021, after the activities covered by the previously executed technology transfer agreement are complete.

From 2023, Emergent will offer a flexible capacity deployment model to support additional drug substance batches each year.

Emergent BioSolutions senior vice-president and CDMO business unit head Syed Husain said: “Over the next five years, we are committing our leading CDMO services to advance this important vaccine candidate.

“We have the expertise and capabilities to meet the long-term needs of our customers and provide ongoing commercial manufacturing to benefit patients.”

J&J is making preparations for clinical vaccine production at its facility in Leiden, the Netherlands. The company intends to begin Phase I clinical trials of the vaccine in September.

In April, Emergent signed a contract with Janssen for drug substance manufacturing technology transfer services for the vaccine. The contract also involves reserving some large-scale capacity for commercial drug substance manufacturing.

Activities will occur at Emergent’s Baltimore Bayview facility in the US.

Emergent’s facility is said to feature capabilities to manufacture at clinical scale to advance candidates rapidly into the clinic. Also, the facility can help scale up for large-scale manufacturing for commercial volumes.

In June, Emergent secured a $628m contract from the US Biomedical Advanced Research and Development Authority (BARDA) for domestic manufacturing of Covid-19 vaccine candidates.

The company agreed to provide its CDMO capacities, capabilities and expertise as part of the government’s Warp Speed Program to expedite access to vaccines against Covid-19.