Catalent will provide end-to-end services to support lenzilumab in a Phase III study in COVID-19 patients.

In May, Catalent announced it was clinically supporting Humanigen’s anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody lenzilumab for a Phase III clinical trials for COVID-19.

This week, the contract development and manufacturing organization (CDMO) says it has expanded its work with Humanigen to include full end-to-end services for the candidate.

Image: iStock/peshkov

“Humanigen and Catalent have been working together since 2007, but shifted focus earlier this spring to progressing lenzilumab for the treatment of COVID-19, given the current pandemic,” a Catalent spokesperson told us.

“Yesterday’s announcement highlights the full Humanigen and Catalent partnership – from cell line development, integrated development services and accelerated timelines to clinical and potential commercial drug substance manufacturing and vial filling at Catalent’s Madison, Wisconsin and Bloomington, Indiana sites.”

The molecule produced positive data in June in a trial on 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A Phase III study is currently underway evaluating hospitalized COVID-19 patients.

Catalent and COVID

Like many CDMOs, Catalent has been swamped with proposals to assist with the development and manufacture of potential therapies and vaccines targeting COVID-19.

In May, Catalent said it had been presented with around 100 opportunities to help firms develop drugs and vaccines against COVID-19 across all its business divisions. Of these, around 90 involve unique molecules, representing about 45% of all coronavirus products reportedly under active development at the time.

Some of the projects publicly announced by the CDMO include providing fill/finish for J&J’s recombinant vaccine candidate, the manufacture of Arcturus’ potential mRNA vaccine, supporting AstraZeneca’s effort, and  producing drug product for Moderna’s mRNA vaccine candidate.

We asked how the CDMO was able to manage all these new projects amid its network.

“While we can’t comment on production volumes for specific products, both the Bloomington and Madison sites have undergone or are undergoing significant capacity expansions,” the firm told us.

“In 2019 we began a $200 million capital investment across the biologics business to expand both drug substance manufacturing capacity and drug product fill/finish capacity. This investment, initially planned to be phased in over three years, was to meet projected growth among existing and future customers, before COVID-19.

“The expansion at Bloomington will include a high-speed flexible vial line, with a capacity of 300 units per minute, and was on top of a project to add five new packaging suites, which was completed earlier in 2020. The latest expansion has been accelerated to provide capacity for the anticipated demand of various COVID-19 vaccines to meet operational readiness and round the clock manufacturing schedules by January 2021.”

In Europe too, the firm has increased its sterile injectable and intravenous fill-finish capacity, acquiring a facility in Anagni, Italy, from Bristol-Myers Squibb last year.