Getting Gene Therapies to Market Faster with CBM’s Analytical Accelerator

The Center for Breakthrough Medicines (CBM) offers comprehensive AAV testing services with the newly launched Analytical Accelerator^TM for AAV Testing. 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.

CBM’s Analytical Accelerator^TM 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 at a single provider, covering the full spectrum of FDA critical quality attributes including: safety, potency, purity, identity, and stability.

What you will learn:

• Why consolidating providers allows AAV gene therapy developers to ship to a single laboratory, reducing sample volumes needed by up to 50 percent 
• How custom assay development can be performed in half the time (6 months vs. 12) of de novo development using Analytical Accelerator^TM platform methods
• What digital infrastructure and technologies are being implemented at CBM to give clients full and rapid transparency for their ongoing testing projects