Resilience cites GLP-1 demand in $225m+ fill/finish expansion

Resilience, the contract development and manufacturing organization (CDMO) in all-but-name that launched in November 2019, has laid plans to expand fill and finish facilities in Cincinnati, Ohio and Research Triangle Park (RTP), North Carolina. These will complement drug product capabilities at a site in Toronto, Canada, added through the acquisition of Therapure Biopharma’s CDMO assets in 2021.

The 580,000 square-foot West Chester, Cincinnati plant will benefit from at least $225 million to expand drug product capacity. The site has three fill lines for vials, cartridges, and pre-filled syringes (PFS), with a fourth PFS fill line set to come online next year.

The Durham, RTP facilities were acquired from bluebird bio in 2021 for $110 million. The size of the investment has not been divulged as it is still in the planning stage, but the site has 45,000 square feet of grey space being eyed for future drug product operations.

“Our capacity across the network already stands at approximately 150M units and will scale to more than 200M units by 2025. Additional expansion opportunities are in active assessment to further support pharma and biotech innovators,” Rahul Singhvi, CEO of Resilience, told BioProcess Insider.

“With the growing demand for injectable drug product manufacturing capabilities, we saw the strategic need to expand on our already significant investment in fill/finish capacity to be able to broaden our capabilities serve even more customers and patients.”

The GLP-1 factor

According to the firm, the expansions will support multiple modalities and therapeutic indications, including Glucagon-like peptide-1 (GLP-1) drugs.

GLP-1s represent the new wave of diabetes and weight loss blockbusters. Ozempic and Wegovy (both semuglatide) pulled in 113 billion Danish Kroner ($16.4 billion) for Novo Nordisk in 2023. Diabetes drug Mounjaro (tirzepatide), meanwhile, pulled in over $5 billion for Eli Lilly last year, and – along with recently approved obesity drug Zepbound (also tirzepatide) – is expected to drive revenues going forward.

Novo Nordisk and Lilly are expected to dominate in the GLP-1 field, but others heavily investing in the sector include Roche and AstraZeneca.

As demand for these products rocket, manufacturing capacity has failed to keep up leading to supply shortages coming to the forefront in 2023. Such concerns are believed to have driven the recent announcement by Novo Holdings to buy CDMO Catalent for $16.5 billion.

The deal includes plans to sell three fill/finish facilities to Novo Nordisk (of which Novo Holdings is the major shareholder), set to ensure drug product supply of Ozempic and Wegovy. However, such in-housing of third-party capacity is worrying the wider industry and could lead to further shortages going forward.

“The effects of such a deal is hard to predict as there are many variables, but the popularity and potential of the GLP-1s as a class of drugs in and of itself is having significant impact by putting substantial demands on fill/finish capacity globally,” Singhvi told us.

Yet while the Novo-Catalent acquisition “signals a shift in the industry with regards to the need for additional drug product manufacturing capacity,” Resilience’s own CAPEX decisions were made last December, prior to any knowledge of this deal, he added.

“Prior to that, in January 2023, we also made a commitment to broadening our focus to include end-to-end fill/finish capabilities by acquiring our Cincinnati facility from AstraZeneca, so this is something that we’ve been planning for some time. The recent announced deal with Catalent only make this investment more critical.”