BIO International: US CDMO looks to plug critical cell therapy manufacturing capacity shortage

By Jane Byrne contact

- Last updated on GMT

© GettyImages/dra_schwartz
© GettyImages/dra_schwartz

Related tags: Natural killer cells, CAR-T, Gene editing

The BIO International Convention in San Diego this week heard the US-based Center for Breakthrough Medicines (CBM) is to speed up plans to build what it calls the largest cell therapy manufacturing operation worldwide.

Launched in early 2020​, the contract development and manufacturing organization (CDMO) was formed by the Discovery Labs and Deerfield Management Company to alleviate what they called the critical lack of manufacturing capacity preventing patients from accessing critically needed cell and gene therapies. 

That capacity gap is hindering the development of cellular immunotherapies such as engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies for patients with hematological and solid tumors, said the organization.

Lowering cost, shortening timelines

It is working now with multiple academic institutions and innovator companies to advance critical modalities, lower cost, shorten timelines and scale manufacturing of approved therapies so that all patients can receive treatment, it said. Indeed, in January this year, the organization revealed it had received US$350m in equity financing from Korean company, SK Inc. 

Occupying over 40% of The Discovery Labs’ 1.6 million square foot biotech, healthcare and life sciences campus in King of Prussia, Pennsylvania, CMB currently offers process development, plasmid DNA, viral vectors, cell banking, cell processing, and support testing capabilities.

And planning has got underway, it said this week, on a massive expansion of its cell therapy manufacturing suites and supporting infrastructure, which when completed will have the ability to produce treatments for more than 10,000 patients per year, said the company.

The expansion will ensure the facility can adapt an array of cell types, manufacturing processes, and capacity demands to maximize efficiency while minimizing costs, said the CDMO.

To further enable next-generation cell therapies, the CBM team said they also plan to implement rapid autologous manufacturing, high-fidelity gene-editing capabilities, and fully automated processes prior to the facility coming online.

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