Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing critical challenges associated with the commercialization of cell and gene therapies, has signed an agreement with Asimov, a Boston-based mammalian synthetic biology company, to license Asimov’s clonal HEK293 suspension cell line for the production of viral vectors.
 
HEK293 cell lines are the industry standard for producing therapeutic viral vectors, the most widely used vehicle for the delivery of gene therapies. With the rise in approvals for new therapies, CBM will now be able to offer its clients immediate access to a high-performance clonal GMP-qualified cell line as part of its comprehensive capabilities for vector manufacturing designed to deliver high yields and higher throughput without comprising quality.
 
“Many gene therapy developers need immediate access to a cell line for the production of their therapeutics. Last year, our process development group evaluated multiple commercially-available HEK293 platforms and chose Asimov’s to provide to clients,” said Sybil Danby, Senior Vice President of Business Development and Strategy for CBM. “We believe our agreement with Asimov provides significant value to our manufacturing partners and the patients to which they are looking to deliver life-changing and lifesaving therapeutics.”
 
Immediately available manufacturing capabilities supported by this clonal cell line will include both GMP manufacturing (up to 1000L scale) and non-GMP productions (up to 500L). GMP productions will be conducted in CBM’s modularly designed vector manufacturing suites that support 2-5 times greater batch throughput than traditional ballroom designs while maintaining maximum flexibility in production platforms. Non-GMP productions will be conducted in CBM’s pilot plant with a proven first-time right process development approach and expert teams.
 
“We believe this is the initial step of many with Asimov, an industry leader in mammalian synthetic biology and cell line development,” said Avi Nandi, Chief Technical Officer at CBM. “We continue to make significant investments into our technology platforms to ensure our clients have access to an end-to-end solution that allows them to develop and manufacture at lower costs. Our goal is for rare disease therapies to be accessible to as many patients around the world as possible and our relationship with Asimov removes a key barrier to therapy developers.”
 
The agreement closes on the heels of CBM’s recent launch of their Genesis Vector Manufacturing Solutions, 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 services co-located at a single site to accelerate development and manufacturing timelines of vector-based advanced therapies.
 
“CBM is well known for its commitment to its clients and, most importantly, to the patients those clients serve, and we are thrilled to work with them as the need for therapeutic viral vectors continues to rise,” stated Alec Nielsen, Asimov’s CEO. “The technology to design and manufacture viral vectors is constantly evolving, which is why at Asimov we’re developing full-stack tools, from host cells, to optimized genetic systems, to bioreactor process models. Our goal is to enable partners like CBM to improve vector titers, product quality, and bioreactor scalability, in order to increase access to advanced therapies.”