Catalent is vying for a stronger foothold in next-gen drug development, and it's betting on developers' need for speed. On the heels of launching a new gene-to-drug program, the Florida-based contract development and manufacturing organization (CDMO) just announced a partnership with Ori Biotech, a heavyweight in the automated cell therapy manufacturing arena.
Catalent will join Ori’s Preferred Partner Network (PPN), a combination of academic medical centers and CDMOs that will integrate Ori’s proprietary Iro platform into their development and manufacturing as part of an industry-wide effort to speed up the gene and cell therapy pipeline.
In exchange for the technology boost, Catalent brings its scale and reach. Catalent’s Princeton, New Jersey facility will become an Iro center for excellence, focused on delivering autologous cell therapies, personalized therapies built from a patient’s own cells, to a wider breadth of clientele.
“At Catalent, we recognize the need for advanced manufacturing technologies to help deliver commercially viable CGT 2.0 therapies … automated, closed platforms like IRO will be critical to making that science reproducible, scalable and accessible to more patients,” said John Tomtishen, global head of cell therapy field application scientists and strategic alliances at Catalent.
A frontrunner in the automated cell and gene therapy space, Iro allows developers to automate “longest, most manually intensive part” of the cell and gene therapy production process, the biotech’s website reads. The platform is a combination of patented hardware, software and data analytics. The physical devices used in the system are a little bigger than a microwave oven and can be stacked to scale production.
Ori has repeatedly touted the platform’s ability to increase production, accelerate development timelines and reduce input costs. Last year, the FDA backed the technology, giving it the highly sought-after advanced manufacturing technology designation. And just weeks before the Catalent partnership, Ori announced that an unnamed biopharma will bring on the Iro platform as part of a 10-year, $120 million pact.
News of the Catalent-Ori partnership landed just a day after Catalent’s Monday launch of its own “accelerated gene-to-drug substance program” for complex biologics. Through the new offering, Catalent will help clients move next-generation molecules, like bispecific and multispecific antibodies, from gene sequence to a drug substance up to good manufacturing practice standards in just 10 months, the CDMO said in a release.
The new offering falls in line with Catalent’s ongoing mission to be an end-to-end development partner for high-value medicines, rather than a traditional CDMO.
“We’re a strategic partner; we enable life-changing therapies—so we’re not just a service provider, and we take that really seriously,” Trish Hunt, group vice president and chief marketing officer at Catalent, told Fierce in an interview last year.
Through the program, Catalent aims to give developers a more standardized biologic pipeline and bring said pipeline up to a speed traditionally associated with monoclonal antibodies. The new service builds on the rapid antibody package Catalent launched in January for monoclonal antibodies, which takes a gene through to drug substance in as little as eight months.
According to the program’s new targets, Catalent will deliver a master cell bank, the cells that will produce the biologic of interest, in just seven months. By nine months the bulk active ingredient will be ready to fill, and by month 10 the batch will be through quality checks and ready for clinical testing.