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
Speaker Info:
Dan Stringer is a business development director supporting testing and analytical services at CBM. He has over 20 years of industry and laboratory experience. Dan received his Ph.D. in cell biology from the University of Iowa where he studied protein trafficking and degradation. He then went on to the National Cancer Institute where he did a post-doctoral fellowship on mitochondrial function. Dan joined industry in 2015 with Bio-Rad Laboratories where he was a field application scientist and biopharma account executive focusing on proteins and genomics products. Dan has also worked at several other companies. In his free time, Dan likes to keep bees and lives near Frederick, MD