Merck

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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Request information from our upstream and downstream process development experts:


Process Development

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

The breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization.

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.

Cell Bank Manufacturing
Cell Bank Manufacturing

Get it right the first time by letting us handle your MCB production at our cGMP facilities in the U.S. and U.K., as well as production of your working cell bank (WCB) 


Manufacturing

With over 25 years of GMP experience we are an established CDMO with a multi-disciplinary team with over three decades of experience with hundreds of biologics – providing technology, equipment, and expert counsel you can trust.

Biologics fast track

Our Fast-Track development service accelerates progress toward clinical and commercial milestones. 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.


25+ YEARS OF EXPERIENCE IN GMP MANUFACTURING

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

  • Merck 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