Center for Breakthrough Medicines (CBM) Expands Contract Testing Services with the launch of the Analytical Accelerator™ for AAV Testing to Serve Growing Pipeline of Gene Therapies

Platform Methods Reduce GMP Turnaround Times (TAT) by Three-fold From 22 Weeks to 6 Weeks

King of Prussia, PA — October 19, 2022 —The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the testing challenges associated with commercializing cell and gene therapies, announced today the launch of their Analytical Accelerator^™ for AAV Testing to help gene therapy developers meet the quality domains of identity, safety, purity, potency, and stability required by the Food and Drug Administration (FDA) and global regulatory authorities.

“Given recent gene therapy approvals and a growing clinical pipeline, there is currently a severe shortage of Good Manufacturing Practices (GMP) testing capacity for AAV-based gene therapies, resulting in extremely long leads for key assays, missed turnaround targets, and the need to rely on five providers on average to get AAV-based gene therapies tested,” said Joerg Ahlgrimm, CBM’s Chief Executive Officer. “Launching this cohesive set of 40+ GMP AAV platform assays and domain-specific modules supports our recently announced plans to build the most comprehensive contract testing capabilities in the world.”

CBM’s Analytical Accelerator^™ for AAV Testing Platform speeds time to GMP batch release more than three-fold (22 to 6 weeks) with no wait times and a complete package of platform assays across the full spectrum of FDA quality domains located at a single provider. Consolidating providers allows AAV gene therapy developers to ship to a single laboratory, reducing sample volumes needed by up to 50 percent. Beyond platform assays, custom assay development has been performed in half the time (6 months vs. 12) of de novo development using Analytical Accelerator^™ methods. This comprehensive, single-source approach significantly saves time and costs.

“Everyone at CBM comes to work to make therapies for patients – especially those with rare genetic disease with no approved treatments,” said Dana Cipriano, Sr. Vice President of Testing and Analytical Services for CBM. “This comprehensive offering will drive down the costs of AAV-based gene therapies and bring much needed testing capacity to improve access for the patients that need them. The Analytical Accelerator^™ for AAV Testing Platform combined with our first-time right process development approach and no wait time for GMP slots for manufacturing along with our batch success guarantee, positions CBM to offer the most integrated AAV capabilities to our clients to bring the next-generation of AAV-based gene therapies to market faster.”

“Drug material is extremely precious when it comes to rare diseases or any other small-batch production (e.g., individualized medicines). All partners involved must be resourceful, creative, and fully comply with regulatory requirements,” said Julia Taravella, Executive Director of Rare Trait, a non-profit biotechnology research company who selected CBM as its testing partner for AAV9 drug release for a Phase I clinical trial to treat Aspartylglucosaminuria (AGU), a fatal childhood disorder that presents like autism. “CBM’s attention to details and customer priorities will help bring the treatment to more patients living with AGU and accelerate our path to clinic and market.”

Visit https://now.breakthroughmedicines.com/aav-testing-platform 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, viral 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.

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