Cellares has inked its first international deal with Bristol Myers Squibb, with the cell therapy manufacturer noting it is going through “tremendous tailwinds” from the Biosecure Act with increased interest from many potential clients.

Bristol Myers has reserved clinical and commercial capacity for an undisclosed number of CAR-T therapies at Cellares’ future facilities in the US, EU and Japan, which are slated to open in the next few years. “We’re building out unprecedented amounts of cell therapy capacity,” CEO Fabian Gerlinghaus told Endpoints News in an interview.

The Bristol Myers deal is worth $380 million in upfront and milestone payments. Cellares will tech-transfer the pharma company’s CAR-T therapies into its automated platform, dubbed the Cell Shuttle. It will also get access to Cellares’ recently announced automated quality control platform.

As biopharma companies seek US-based cell manufacturers, they are competing with each other over Cellares’ offerings, Gerlinghaus said. “Whether the Biosecure Act passes or not, the mere fact that Congress is thinking about forbidding American pharma companies from working with WuXi is making a lot of pharma executives very, very nervous,” he said.

The Novo-Catalent deal has also given Cellares an opening, Gerlinghaus added. “There’s obviously always conflicts of interests. You don’t necessarily want your competitor pharma company manufacturing your products,” he said.

It’s crucial to have global capacity as CAR-T therapies need to be made as locally as possible, Gerlinghaus said. “From the pharma perspective, whoever can meet patient demand really grabs market share. So from that perspective, capacity is king,” he said.

Cellares has two US-based facilities set to open this year, with the first located in South San Francisco, CA, and the second in Bridgewater, NJ.

In August, Bristol Myers participated in Cellares’ Series C raise and then expanded its proof-of-concept partnership with the manufacturer in October to assess the abilities of the Cell Shuttle to make its CAR-T therapies.

“Our collaboration with Cellares strengthens our existing internal manufacturing capabilities for CAR-T cell therapies by giving us access to the first end-to-end fully automated cell therapy manufacturing platform, to help ensure we meet the high demand for these differentiated treatments, now and in the future,” Bristol Myers’ cell therapy business president Lynelle Hoch said in a statement.

Cellares has other CAR-T partnerships. In November, Cabaletta Bio announced a proof-of-concept deal for the manufacturer to make its clinical-stage autoimmune therapy. In September, Lyell Immunopharma tapped Cellares to make its clinical-stage CAR-T for solid tumors that express the protein ROR1.

Source:
https://endpts.com/bristol-myers-cellares-sign-global-car-t-deal-as-biopharma-companies-look-to-diversify-manufacturing-partners/
GMP mRNA
Check out our AAV CDMO service to expedite your gene therapy research
About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.
READ MORE

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
READ MORE
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.
READ MORE