MilliporeSigma Introduces Comprehensive AAV Express Platform For Streamlined Gene Therapy Production

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, proudly announces the launch of its AAV Express Platform. Designed to streamline and de-risk AAV manufacturing for gene therapies, this comprehensive platform offers a scalable, cost-effective, and high-performing solution for preclinical development through GMP production of AAV.

In conjunction with end-to-end viral vector CDMO capabilities, from plasmids through fill/ finish, the AAV Express Platform delivers high titer, yield, and quality performance, allowing gene therapy innovators to benefit from a collaborative and efficient path to AAV GMP production.

• Strong performance and productivity: 8e11 gc/mL at harvest and >85% full capsids
• Proven scalability: From 50L to 2,000L, to meet diverse clinical and commercial demands
• Accelerated timelines: From feasibility studies to GMP batches in <12 months
• Serotype expertise: Working experience with AAV2, AAV5, AAV6, AAV8, AAV9, and more
• Established analytics: 25+ pre-qualified assays for AAV characterization
• Cost-savings: Limited process optimization, standardized raw materials, templated documentation
• Regulatory Expertise: Comprehensive regulatory support throughout the product lifecycle, from IND/CTA to MAA/BLA filings

MilliporeSigma, a leading contract development and manufacturing organization (CDMO), has been at the forefront of viral vector production since the early days of gene therapy clinical trials in the 1990s, and contiues to support cell and gene therapies from preclinical through commercial production of suspension and adherent-based platforms.

Located in Carlsbad, California, MiliporeSigma‘s state-of-the-art viral vector development and manufacturing facility offers comprehensive, end-to-end capabilities and flexible solutions including upstream and downstream production suites, fill/finish capabilities, warehousing, quality control laboratories, and process and analytical development labs.

Learn how you can accelerate your gene therapy program with a CDMO you can trust by clicking here.