mAbs CTDMO Services

Our mAb Offering

Our highly experienced experts will help you to optimize, scale, and validate your manufacturing process to get you to late clinical and commercial success. And if at any point you need to tech transfer, we can facilitate late-stage tech transfer with a direct, efficient, and robust process wherever you need to go.

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Our Capabilities

Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your biologics.

Biologic Process Development
Biologic Process Development

As you move from cell line to upstream and downstream process development, we can help you build a robust, scalable process that brings you success now and into the future.

Cell Line Development
Cell Line Development

Our full cell line development capabilities and expertise span from DNA and vector constructs to top clonal selection, research and master cell banks, and stability studies.

Clinical & Commercial Drug Substance Manufacturing
Clinical & Commercial Drug Substance Manufacturing

We provide clinical and commercial drug substance supply globally based on harmonized templates and single-use equipment across drug development clinical and commercial manufacturing.

Fast-Track Biologic Drug Development Program

Our Fast-Track development service accelerates progress toward clinical and commercial milestones. We combine best-in-class templates, a multi-disciplinary team informed by three decades of technical experience, a full understanding of evolving regulatory requirements, and project managers fully vested in your success. Our single-use technologies offer unmatched flexibility for both clinical and commercial scale production, and for those times when demand changes unexpectedly. We are nimble, agile, and will advance your project quickly while mitigating risk – and that adds up to greater confidence for you.

Biologics fast track

Our Fast-Track capabilities span every step from DNA to commercial production.

Learn more about our Biologics fast track

Clinical and commercial manufacturing success

Our three biodevelopment centers across the USA, France, and China, allow us to reserve slots to fit your timeline. Plus, our industry-leading single-use technology, give us the flexibility to reserve slots for small batches or increase capacity for large ones in alignment with your needs.


We are an established CDMO and our multi-disciplinary team has more than three decades of experience with hundreds of biologics – providing technology, equipment, and expert counsel you can trust. Since 2012, we have used single-use technology to produce:

  • mAbs: More than 60 GMP batches manufactured in scales from 200 L to 2,000 L
  • Recombinant proteins: More than 15 GMP batches manufactured in scales from 200 L to 1,000 L
  • Fab: More than 3 GMP batches manufactured in 200 L scale
  • Fc-fusion: 1 GMP batch manufactured in 200 L scale

Our Track Record

  • MilliporeSigma Quality System
  • 20+ years in regulatory compliance
  • 100% single-use technology
  • We manage our own supply chain

Our regulatory expertise can help you mitigate risk, providing data in line with a robust validation strategy and by regular upfront interaction with regulatory authorities. We support your CMC content writing for your clinical and commercial applications, as well as develop a fool-proof regulatory strategy. With 25+ years of experience in GMP biopharma manufacturing and 85+ GMP Drug Substance batches released, our dedicated team will design and manage your process with openness and transparency at every stage.

Testing Services

A Global Network of Three Biopharma Development and Manufacturing Facilities

Scientist at drawing board
Burlington, MA
  • Fully single-use manufacturing capabilities
  • Pilot production up to 200 L
  • Non-GMP clinical production
  • 100% success rate in client audits
  • Footprint 1,500m²
Martillac, France
Martillac, France
  • Fully single-use manufacturing capabilities
  • Pilot production up to 200 L
  • GMP clinical production up to 4,000 L
  • GMP commercial production in 2022
  • 8 single-use bioreactors
  • 3 manufacturing suites
  • Footprint 4,100m²
  • Quality Control lab 1,500m²
  • Analytical methods development lab 400m²
  • GMP-certified since 1995
  • Audited and approved by the French Health Authority ANSM
  • Inspected by the U.S. FDA, Japanese, and Australian authorities as well as many biotech clients
Shanghai, CN
Shanghai, China
  • Fully single-use manufacturing capabilities
  • Pilot production up to 200 L
  • GMP clinical production up to 2,000 L
  • Footprint 5,150m²
  • Compliant to NMPA, U.S. FDA, and EMEA

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