Cellares Innovates With Automated Cell and Gene Therapy Platform

There’s no doubt that things are moving quickly in the field of cell and gene therapy. Less than a decade into market availability, there are more than 10 FDA-approved cell therapies available (1), including first-in-class tisagenlecleucel (Kymriah; Novartis), which was approved in 2017 for the treatment of acute lymphoblastic leukemia in children and young adults. Soon after, three more CD19-specific CAR T-cell therapies were approved by the FDA for the treatment of different B-cell malignancies, namely axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), and lisocabtagene maraleucel (Breyanzi), and more continue to come to market for additional indications.

An August 2023 report from market research firm Roots Analysis (2) revealed that “over 1,000 cell and gene therapy candidates are currently being investigated for the treatment of various disease indications.” The report went on to say that “in order to ensure the optimum use of their resources and augment their revenue generation opportunities, a number of cell therapy companies engaged in this market offer contract services, in addition to their in-house manufacturing capabilities. In recent years, several big pharma players have undertaken initiatives, including establishing strategic partnerships, seeking investment from venture firms, and carrying out expansion projects, in order to enhance their capabilities.”

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One of those companies leading the charge is San Francisco-based Cellares, a self-titled Integrated Development and Manufacturing Organization (IDMO) that provides cost savings, scalability, and drug product quality improvements versus traditional manufacturing techniques. In an interview with Pharmaceutical Technology, Fabian Gerlinghaus, CEO and co-founder, Cellares, set the stage to understand what it took to innovate in a fiercely complex technology and tightly regulated space.

In the first segment of this interview, Gerlinghaus describes the scalability achieved with the Cell Shuttle platform and integrated consumable cartridge automated platform. All unit operations take place inside the single-use consumable cartridge. Cellares can load up to 16 cartridges into the Cell Shuttle, running up to 16 different processes simultaneously. According to Gerlinghaus, the Cell Shuttle reduces the amount of labor required by about 90% due to the automation, saying “it’s equivalent to about 100 different bench top instruments in one machine, in a very compact, tight space [requiring] about 90% less facility space. So, you put those two things together, a 90% reduction in labor required.” He goes on to emphasize that this results in about a 50% lower price per batch compared with conventional CDMOs. In a complex set of manufacturing operations, full automation can apparently “reduce process failure rates by about 75% compared with open and manual cell type manufacturing methods based on bench-top equipment” by greatly reducing both contamination and operator error.

Watch part 1 of our interview with Gerlinghaus below:

REFERENCES

(1). Approved Cellular and Gene Therapy Products. US Food and Drug Administration. Updated February 21, 2024. Accessed March 6, 2024. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
(2). Top 10 Cell and Gene Therapy Companies. Roots Analysis. August 2023. https://www.rootsanalysis.com/key-insights/10-leading-cell-and-gene-therapy-companies.html