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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.

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

Raw Material Testing
Our raw material testing helps ensure the quality and purity of materials used in biologics production.
Cell Line Characterization
Cell line characterization is critical to both confirm the origin of the cell line and to ensure your master cell bank and working cell banks are free of contaminants and adventitious agents such as, bacteria, fungi, mycoplasma, and viruses.
mAbs Bulk Harvest Release Testing
Bulk harvest is the batch of materials taken from a bioreactor during the manufacture of a biologic. Typically comprising cells, spent media, the biologic, and any by-products of the reaction, this complex mixture requires rigorous testing to confirm the absence of any adventitious agents and ensure its suitability for downstream processing.
Interlot & Biosimilar Comparability
If your mAb is an original product or a biosimilar, our comparability studies ensure robust and reproducible mAb production while establishing comparability between different production facilities or between biosimilars and original products.
mAbs Final Product Release Testing
Our GMP testing of final mAb product packages simplifies the challenge of demonstrating regulatory compliance for every lot used in preclinical and clinical studies, while ensuring that active ingredients are free of contaminants.
Next Generation Sequencing
Our next-generation sequencing (NGS) biosafety testing services deliver deep insights into biologic therapeutics such as monoclonal antibodies, viral vectors, and novel vaccines, rapidly characterizing your process while identifying known and unknown agents with pinpoint precision and accuracy.

Related Resources

Case Study: Optimize the Formulation for a Monoclonal Antibody
Case Study: Reduce the Host Cell Protein from Bioreactor Harvest
Case Study: Scale Your Process Directly from 3 L to 2,000 L
eBook: Optimize Your Analytical Package for Greater Risk Reduction
Best Practices: Tech Transfer Key Considerations
CDMO Case Study: Be Ready for Commercial-Scale Single-Use Manufacturing
Whitepaper: Trends in Outsourcing the Development and Manufacturing of Biologics

Related Webinars

Webinar: Tech transfer and Scale-up - Tips and tricks from a Biodevelopment Center
Webinar: A Scale up to 2000L, Blindfolded

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

Related Applications

Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
Antibody-Drug Conjugate (ADC) Manufacturing
Antibody-drug conjugation (ADC) technology uses monoclonal antibodies (mAbs) to deliver potent, highly active pharmaceutical ingredients (HPAPIs) to targeted cells. Learn about processes and areas of expertise required to advance your ADC to market.
ADC & Bioconjugation
Bioconjugation involves ligating molecules together in which at least one of the reactants is a biomolecule, often an antibody, protein, or oligonucleotide, for detection, assay, or targeting and tracking of the biomolecule.
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