Automation a Path to Lower Cell Therapy Costs

Australian developer Currus Biologics says automating the production process for CUR-001, a candidate cell therapy for solid tumors, has significantly reduced the amount of viral vector required to make the product.

CEO Sam Cobb shared details of the project this week, telling GEN that, in a bid to minimize manual handling requirements, the firm transferred the existing CUR-001 manufacturing process to the Cocoon automated production platform.

“This involved optimizing several key manufacturing parameters, including the amount of lentiviral vector required for transduction, cell densities during seeding and transduction, and the use of different starting materials.

“Importantly,” she continues, “this optimization enabled us to reduce the amount of lentiviral vector required for manufacturing, which has the potential to significantly reduce manufacturing costs.

“The objective was not to change the fundamental biology of CUR-001, but to establish a more consistent, reproducible, and efficient manufacturing process that can support future clinical and commercial development.”

The optimized process has now been transferred to Melbourne-based contract manufacturer, Cell Therapies (CTPL), which will produce CUR-001 for Currus’ planned Phase I clinical trial program.

The process automation project was supported by Swiss CDMO Lonza, which until recently owned a controlling stake in the Cocoon platform, and Octane Biotech, the original developer that re-acquired the technology in March.

Scale-up benefits

Automating the CUR-001 production process is also likely to aid Currus and its manufacturing partners as the cell therapy moves through clinical development toward commercial launch, Cobb says.

“One of the advantages of the Cocoon platform is its modular design, which allows manufacturing capacity to be expanded by adding additional units rather than fundamentally changing the manufacturing process.

“A final decision on commercial manufacturing will depend on clinical outcomes, regulatory requirements, anticipated patient demand, manufacturing capacity, and commercial economics,” she says.

Automation advantages

Process automation is likely to become more common in CAR T cell therapy manufacturing, but the widespread use of fully autonomous processes is unlikely, according to Cobb.

“One of the major barriers to broader adoption of autologous CAR T cell therapies is the complexity and cost of manufacturing individual patient batches. Automation provides a way to address both challenges while improving process standardization.”

Some core parts of cell therapy production can already be automated, with things like cell selection, activation, genetic modification, expansion, and harvest being the obvious examples.

However, other aspects of production—material collection, sampling quality control, batch review and release, cryopreservation, and distribution—may prove harder to automate, Cobb says.

“Some of these activities may also become increasingly automated, but I do not think fully autonomous manufacturing is a prerequisite for achieving meaningful improvements in efficiency,” she adds.

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