MilliporeSigma Becomes One Of The First CDMOs To Provide Full Viral Vector Offering With Launch Of VirusExpress® 293 Adeno-Associated Virus Production Platform

• Reduces process development time by an estimated 40 percent
• Enables biopharmaceutical companies to increase the speed to clinical manufacturing
• Adds to company's best-in-class VirusExpress® Lentiviral Production Platform

Burlington MA /PRNewswire/ - MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, has launched the VirusExpress^® 293 Adeno-Associated Virus (AAV) Production Platform, making 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 commercialized in half the time compared to traditional therapies," said Dirk Lange, Head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany. "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 percent, 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. 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 labor-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.

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About the Life Science business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 26,000 employees and 55 manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.

Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck KGaA, Darmstadt, Germany generated sales of € 19.7 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit www.emdgroup.com.