Catalent to provide large-scale fill/finish for J&J coronavirus vaccine project

Catalent, the latest CDMO to support Johnson & Johnson’s COVID-19 vaccine candidate, will carry out aseptic vial filling and packaging from its site in Bloomington, Indiana.

Johnson & Johnson (J&J) began working on its vaccine strategy to combat COVID-19 – caused by the novel coronavirus (SARS-CoV-2) – in early January, identifying last month a lead candidate and two backups based on Janssen’s AdVac viral vector and PER.C6 cell line technology.

As the programs move towards the clinic, J&J has been laying plans to ensure it has manufacturing capabilities and capacity to support trials and – if successful – large-scale production of a billion doses or more.

Image: iStock/LorenzoT81

The firm is looking to grow and optimize its own network but is also turning to contract development and manufacturing organizations (CDMOs) for large-scale support. Last week, large-scale vaccine production capacity was reserved at Emergent Biosolutions’ facility in Maryland in a $135 million deal, and this week the firm has turned to Catalent for its fill and finish capabilities.

“Catalent will provide segregated manufacturing capacity over the coming months to prepare for rapid scale-up of high-speed aseptic vial filling and packaging for Johnson & Johnson’s lead vaccine candidate,” Catalent spokesperson Chris Halling told Bioprocess Insider.

The intention is to achieve “operational readiness and 24×7 manufacturing schedules by January 2021,” and to do this the firm will hire 300 additional employees at its 875,000 square-foot site in Bloomington, Indiana with recruitment beginning in July.

No financial details of the deal have been disclosed.

However, Halling said Catalent has been able to take on the program in part because of the proactive investments previously announced at the site. Earlier this month, the CDMO completed a $14 million expansion, which added 15,000 square feet of packaging infrastructure, including five new packaging suites and a new quality control laboratory. And in 2018, the firm announced plans to invest around $100 million to double fill and finish capacity at the site.

“A part of that investment will be dedicated to the J&J program.”

Evan Stover, an analyst from Baird Equity Research reacted positively to the news. “Encouraging to see COVID partnership with a high-profile client,” he said in a note. “We’ve received investor questions around whether Catalent has adequate fill-finish capabilities to materially support COVID vaccine and treatment production. This relationship should answer that question.”

He added: “J&J is targeting one billion plus doses globally, potentially supported by multiple partners, whereas Catalent produces 73 billion doses annually across all products.”

There are over 90 vaccines programs looking to combat COVID-19, caused by the novel coronavirus (SARS-CoV-2). However, Sanofi stressed this week how important it is to have a large-scale manufacturing strategy set up in order to be prepped for potential clinical success. Sanofi has two COVID-19 vaccines under development.