CBM Streamlines Cell and Gene Therapy Manufacturing Capabilities with Autolomous Digital Platform
By Alex Keown
January 24, 2023
In its quest to be one of the top Contract Development and Manufacturing Organizations in the world, the Center for Breakthrough Medicines (CBM) will implement a robust digital solutions system that will support end-to-end cell and gene therapy manufacturing processes.
CBM, which garnered BioBuzz’s 2022 Employer of the Year Award, started 2023 by licensing London-based Autolomous LTD’s AutoloMATE platform to deliver seamless digital connectivity to its manufacturing capabilities. Jeet Sarkar, Vice President and Head of IT at CBM, said the Autolomous platform will help CBM digitize all batch record reviews and streamline its manufacturing capabilities and operations.
“At CBM, our vision is to be the best-in-class contract development management organization. This will improve our core competence and improve our patient services,” Sarkar said.
Since its founding in 2019, CBM has expanded its capabilities to provide preclinical through commercial manufacturing of cell and gene therapies for client companies. Last year, the company forged a gene therapy agreement with the University of Pennsylvania’s Gene Therapy Program that combines the knowledge of academic researchers with CBM’s manufacturing capacity. The five-year partnership aims to move experimental gene therapies safely and rapidly from concept to clinic by combining the strengths of both organizations.
Sarkar said the organization realized it would need a state-of-the-art, scalable manufacturing system to meet those goals and the Autolomous platform checked all of the boxes. Sarkar pointed out the Autolomous platform is especially geared toward improving cell and gene therapy production, which was a plus. Not only will the program improve transparency and batch-tracking records, Sarkar said the platform helps CBM’s long-term vision of having a “zero-defect manufacturing process.”
“We want to get it right the first time, every time,” Sarkar said. “Getting it right the first time is a priority for us and this will enable us to get there.”
Sarkar noted chain of custody and identity are highly critical in the manufacture of cell and gene therapy products. Sarkar said a secure chain of custody can make the difference between life and death for the patients the organization ultimately serves. Having a digital platform capable of keeping track of these is critical for accountability.
The digital-first manufacturing platform will minimize obstacles in scaling and manufacturing. Additionally, Sarkar said the Autolomous platform will benefit compliance regulations and expedite potential approval of cell and gene therapy products manufactured by the organization. The platform is expected to promote shorter investigation timelines which lead to lower costs of goods and higher productivity, he added.
“This definitely helps us scale up our manufacturing faster and will enable us to meet our vision of zero defects,” Sarkar restated. “It will benefit the patient and simplify the chain of custody.”
CBM is now in the process of implementing the new system. The organization is currently running draft batches and Sarkar estimated the platform will be in full use in April.
Beyond the Autolomous platform licensing, CBM also struck an agreement with Boston-based Asimov to license that company’s clonal HEK293 suspension cell line for the production of viral vectors. These cell lines are an industry standard for the production of therapeutic viral vectors, which are widely-used delivery vehicles for gene therapies.
With the licensing, CBM will now be able to provide clients with this high-performance clonal GMP-qualified cell line. Additionally, the new cell line will allow CBM to provide its customers with access to an end-to-end solution that allows them to develop and manufacture at lower costs, the organization announced.
Both the new cell line and the Autolomous platform follows close on the heels of CBM’s launch of its Genesis Vector Manufacturing Solutions. The GVMS is an end-to-end offering that includes plasmid manufacturing, first-time-right process development, high-throughput GMP vector manufacturing suites, and integrated testing and analytics, supply chain, and regulatory service. It is designed to support a wide variety of vectors, including viral-based products.