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 AcceleratorTM 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 AcceleratorTM 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 AcceleratorTM platform methods
- What digital infrastructure and technologies are being implemented at CBM to give clients full and rapid transparency for their ongoing testing projects