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MilliporeSigma

AAV Production

Manufacturing operator in PPE operates a 1,000L single-use bioreactor during AAV production

Power Your Gene Therapy Pipeline with a Proven AAV CDMO Partner

With 30+ years of experience in viral vector development and manufacturing, we bring unmatched expertise as your trusted CDMO for AAV. From plasmids to fill/finish and advanced analytics, we provide true end-to-end support, accelerating your path to the clinic and beyond.

Empowering your AAV-based therapy from preclinical to commercial GMP manufacturing with speed and confidence:

  • Our AAV Express Platform delivers scalable, reproducible, and high-performing solutions
  • Our tailored tech transfer approach offers a comprehensive and flexible solution to de-risk and scale-up your program

Our Track Record

30+

Years of Development and Manufacturing Experience

<12

Months to GMP Batch

50L to 2000L

Clinical to Commercial Scalability

25+

In-house Analytical Assays

>70

AAV Batches Produced


Confidence to Meet Every Milestone

Through a defined process designed by our technical experts you gain confidence in the clinical and commercial manufacturing of your AAV-based gene therapy.

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Our AAV platform offers fully comprehensive support to reduce costs and meet your timelines:

  • Packaging and transfer plasmids
  • GMP-banked HEK293 cell line and media
  • Extensive serotype experience
  • Optimized GMP production
  • On-site fill/ finish services
  • Established and customized assays
  • Regulatory support services
  • Tech transfer capabilities

Discover Our AAV Express Platform

From plasmid design to fill/finish, our AAV Express platform delivers full-spectrum support to streamline production, cut costs, and accelerate your path to clinic and market in 12 months.

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High Performance

  • 8.5e11 vg/mL harvest titers
  • 70-90% full capsids
  • 30% recovery
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Cost-savings

  • Limited process optimization
  • Standardized raw materials
  • Templated production documents
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Proven Scalable Production

  • Development: 15mL to 200L
  • GMP manufacturing: 50L to 2,000L
  • Flexible operations
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Technical Expertise

  • AAV serotype experience (2, 5, 6, 8, 9, and more)
  • 30+ Years of development and manufacturing experience
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Comprehensive Analytics

  • 25+ In-house panel of pre-qualified assays
  • Customized characterization assays
  • Onsite in-process and release testing
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Regulatory Support

  • IND/CTA initial authoring and review
  • Submission amendment
  • BLA/MAA finalization support

Accelerate Your AAV Therapy to Market with a CDMO You Can Trust

Partner with a team you can trust. Connect with us to discover how our AAV Express platform delivers a cost-effective, de-risked, and streamlined path to GMP production.

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