Center for Breakthrough Medicines Launches Genesis Vector Manufacturing Solutions™ with New State-of-the-Art Vector Suites to Accelerate the Commercialization of Advanced Therapies
End-to-End Manufacturing at a Single Site and High-throughput Vector Suite Design Will Bolster Batch Production Up to Five Times
King of Prussia, PA — December 08, 2022 —The Center for Breakthrough Medicines (CBM), a contract development, manufacturing, and testing organization (CDMO) has launched Genesis Vector Manufacturing SolutionsTM to help innovator companies reimagine vector manufacturing by simplifying the value chain and accelerate their path to clinic and commercial launch.
CBM’s Genesis Vector Manufacturing SolutionsTM is an end-to-end offering that includes plasmid manufacturing, first-time right process development and high-throughput GMP vector manufacturing suites to accelerate development and manufacturing timelines. Integrated testing & analytics, supply chain, and regulatory services co-located with manufacturing at a single site drastically simplifies the vector value chain. CBM’s new, purpose-built facility is engineered and outfitted to support a wide variety of vectors, including viral-based products (such as those used for gene-modified cell therapies in CBM’s previously announced expansion) as well as other novel biologically derived delivery vectors compliant with the most robust segregation controls.
“This past year has been a catalyst moment for gene therapies with approvals and authorizations doubling the number of treatments available, accelerating the need for high throughput manufacturing of diverse vectors used to deliver lifesaving therapies,” said Audrey Greenberg, CBM’s Co-founder and Chief Business Officer. “We are thrilled to complete phase one of our 200,000 sq. ft high-throughput GMP vector production facility which sits alongside in-house plasmid production, testing, and analytics. Our investment in 700,000 sq. ft of capacity and expertise will allow innovator companies to optimize their working capital and focus on driving the science forward.”
Each GMP vector manufacturing suite supports batch output 2-5 times greater than traditional designs while maintaining maximum flexibility in production platforms. The suites offer up to 1000L suspension and 500 m2 adherent capabilities, automated chromatography and tangential flow filtration at multiple scales, scaled out ultracentrifugation, and multiple suites can support aseptic drug substance operations as required. All suites are equipped with real-time process monitoring through digital networks and livestreams of the operations for truly transparent manufacturing. Pilot plant operations with 50-500L scale enable teams to train, develop documentation, and begin the bill of material for GMP manufacturing.
“For the 200 million patients worldwide with rare and ultra-rare genetic diseases, 85% of whom live in developing countries, this end-to-end solution will drive down the costs of advanced therapies and bring much needed access for the patients who need them anywhere,” said Emily Moran, Sr. Vice President of Vector Manufacturing and Supply Chain for CBM. “Our high throughput capabilities, combined with no wait time for GMP slots, inventory-on-hand, and commitment to batch success, positions CBM to bring next-generation cell and gene therapies to patients faster.”
To complement agile and flexible drug substance and starting material capabilities, CBM offers two high-performance fill lines, custom buffer and media prep areas, and process-specific component preparation and sterilization areas that reduce COGs and consumable lead times. Capabilities are underpinned by warehouse and support areas filled with inventory-on-hand for both suspension and adherent manufacturing. The commercial-ready suites meet the rigorous standards of cGMP manufacturing enabling seamless changeover and zero handoff between clinical and commercial manufacturing within the same suite. Integrated analytical & testing capabilities expedite batch release (from 22 weeks to 6) and reduces material requirements up to 50%.
“We are partnering with CBM for our treatment because there’s no room for regulatory error or batch failure when it comes to rare disease,” said Tom Hamilton, Co-founder of FA212, a company dedicated to finding a cure for Friedreich’s Ataxia, a debilitating and life-shortening neuro-muscular disorder. “To make a treatment accessible to the more than 15,000 patients living with Friedreich’s Ataxia, CBM’s single site, end-to-end development, manufacturing, and testing services will accelerate our path to clinic and market.”
Visit https://now.breakthroughmedicines.com/genesis-vector-manufacturing-solutions to learn more.
About The Center for Breakthrough Medicines (CBM)
The Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.
Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO; providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency and speed-to-market dedication.