- MilliporeSigma has launched its AAV Express Platform to accelerate and simplify AAV manufacturing for gene therapy developers.
- The platform offers scalability from 50L to 2,000L and enables GMP production in under 12 months.
MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, has launched the AAV Express Platform to enhance the efficiency and scalability of adeno-associated virus (AAV) manufacturing for gene therapies. The platform aims to provide a streamlined, cost-effective, and high-performing route from preclinical development through GMP production.
The AAV Express Platform integrates end-to-end viral vector contract development and manufacturing organisation (CDMO) capabilities, covering plasmid production through to fill and finish. It delivers a high-titre performance of 8e11 gc/mL at harvest with over 85% full capsids and supports scalability from 50 litres to 2,000 litres to meet varying clinical and commercial needs.
According to the company, the platform can take projects from feasibility studies to GMP batch production in less than 12 months. It also features expertise across multiple AAV serotypes, more than 25 pre-qualified analytical assays, and standardised documentation designed to reduce process development time and cost.
MilliporeSigma’s viral vector manufacturing facility in Carlsbad, California, provides comprehensive CDMO services, including upstream and downstream production, fill/finish, warehousing, and analytical development laboratories.
The company stated that it has supported viral vector production since the early gene therapy trials of the 1990s and continues to advance solutions for cell and gene therapy manufacturing.
