MilliporeSigma, the US and Canada Life Science business of Merck KGaA, has launched the VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform. This milestone makes it one of the first CDMOs and technology developers to provide a full viral vector manufacturing offering including AAV, Lentiviral, CDMO, CTO, and process development.
This new platform enables biopharmaceutical companies to increase the speed to clinical manufacturing while reducing process development time and costs.
"Cell and gene therapies offer the potential for curative treatments and can be commercialised in half the time compared to traditional therapies," said Dirk Lange, Head of Life Science Services, Life Science business sector of Merck KGaA. "By increasing dose yields and dramatically reducing process development time, our VirusExpress 293 AAV Production Platform will accelerate manufacturing of these therapies, ultimately delivering lifesaving treatments to patients faster."
The new platform is an extension of the company's VirusExpress offering, which can reduce process development time by up to 40%, based on MilliporeSigma's experience as a CDMO. The company's VirusExpress Lentiviral Production Platform has enabled customers to increase the speed to clinical manufacturing, achieve five times higher titer than the leading competitor, and transition a legacy process to a templated solution.
MilliporeSigma's VirusExpress Platforms offer a simplified upstream workflow for the production of AAV and Lentivirus, making processes easier to manage, adjust and scale.
By increasing dose yields and dramatically reducing process development time, our VirusExpress 293 AAV Production Platform will accelerate manufacturing of these therapies
In addition to accelerating process development, the suspension culture format allows for larger batch yields to enable more patient doses. Additionally, suspension culture is amenable to scalable robust manufacturing processes, while being less labour-intensive. The chemically defined cell culture media eliminates the safety, regulatory and supply chain concerns related to animal- and human-derived materials.
Flexible licensing allows companies to manufacture vectors by using MilliporeSigma's contract manufacturing capabilities and expertise with access to both the upstream and downstream templates or by using in-house development or a third-party.
MilliporeSigma is a leading CDMO and has been involved in this space since clinical trials for gene therapy began in the 1990s. In October 2021, the company opened its second Carlsbad, California-based facility, more than doubling its existing production capacity to support large-scale commercial manufacturing.
