Platform methods reduce GMP turnaround times (TAT) by three times, from 22 to 6 weeks
KING OF PRUSSIA, Pa., October 19, 2022 /PRNewswire/ — The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the testing challenges associated with the commercialization of cell and gene therapies, today announced the launch of its Analytical Accelerator™ for AAV testing to help gene therapy developers meet the quality areas 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 capabilities for AAV-based gene therapies, resulting in extremely long leads for key testing, missed turnaround targets, and the need to rely on five vendors on average to get AAV-based gene therapies tested,” said Jörg Ahlgrimm, CEO of CBM. “The launch of this cohesive set of over 40 GMP AAV platform tests 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 accelerates GMP lot release time by more than three times (22-6 weeks) with no wait times and a comprehensive set of platform tests in the all FDA quality areas from a single supplier. Vendor consolidation allows AAV gene therapy developers to ship to a single lab, reducing required sample volumes by up to 50%. Beyond platform testing, custom test development was completed in half the time (6 months versus 12 months) of de novo development using Analytical Accelerator™ methods. This complete one-source approach saves a lot of time and money.
“Everyone at CBM comes to work to create therapies for patients – especially those with a rare genetic disease without approved treatment,” said Dana Cipriano, Sr. Vice President of Testing and Analytical Services for CBM. “This comprehensive offering will reduce the costs of AAV-based gene therapies and provide much-needed testing capacity to improve access for patients who need it. no wait times for GMP slots for manufacturing along with our batch success guarantee, positions CBM to offer the most integrated AAV capabilities to our customers to bring the next generation of AAV-based gene therapies to market faster. »
“Pharmaceutical material is extremely valuable when it comes to rare diseases or any other small batch production (e.g. individualized drugs). All partners involved must be resourceful, creative and fully comply with regulatory requirements” , said Julia Taravella, executive director of Rare Trait, a not-for-profit biotechnology research company that selected CBM as its testing partner for the release of the drug AAV9 for a Phase I clinical trial to treat the life-threatening disorder aspartylglucosaminuria (AGU) of childhood that presents as autism. “CBM’s attention to detail and customer priorities will help bring the treatment to more AGU patients and accelerate our journey 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 contracted cell and gene therapy development and manufacturing organization (CDMO) uniquely positioned to enable pharmaceutical and biotechnology companies to develop, test, manufacture and commercialize life-saving therapies and treatments to worldwide. Ideally located in the heart of Philadelphia Cellicon Valley, CBM has brought together the world’s most accomplished cell and gene therapy experts, armed with advanced and innovative technologies, to deliver scalable, best-in-class preclinical capabilities through commercial manufacturing capabilities, including the development of process, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complementary and stand-alone test and analysis capabilities.
Purpose-built and patient-focused, CBM was designed from the ground up to be a more efficient CDMO; providing end-to-end single-source solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency and speed to market.
SOURCE Center for Breakthrough Medicines