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 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.
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“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.”