CBM ramps up bioanalysis services with AAV testing

The Center for Breakthrough Medicines (CBM) has launched an AAV testing service it claims reduces the time to GMP batch release from 22 to six weeks.

Pennsylvania-based CBM’s niftily named ‘Analytical Accelerator for AAV Testing’ service aims to help gene therapy developers meet quality, safety, purity, potency, and demands in a reduced timeline.

According to the contract development and manufacturing organization (CDMO), the platform speeds up time to GMP batch release for its customers by more than three times, from around 22 to six weeks with no wait times.

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Furthermore, the company says the offering allows adeno-associated virus (AAV) gene therapy developers to ship to a single laboratory, reducing sample volumes needed by up to 50 percent.

“Given recent gene therapy approvals and a growing clinical pipeline, there is currently a severe shortage of 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 CEO.

“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 is one of a new breed of privately-funded CDMOs, which have sprung up to target the burgeoning advanced therapies space. Since its inception in early 2020 via $1.2 billion of funding from life science and real estate investment company MLP Ventures and the Discovery Labs, the company has grown its presence and capacity at its site at a former GSK R&D campus in King of Prussia.

Following a $350 million investment by SK Holdings in November 2021, the firm announced earlier this year plans to further increase its manufacturing capacity at the site.