mAb Development and Manufacturing Services
Accelerate the Biologic Drug Development Journey
With Millipore® CTDMO Services we provide deep expertise and flexible solutions across all stages of development and manufacturing for monoclonal antibodies, bi-specific antibodies, fusion proteins, or antibody fragments. We work with our clients to balance risk, optimize speed, and support all aspects of regulatory compliance on the journey to market.
Our services span from mammalian cell line and process development to media and feed screening, master cell banking, scale-up, and GMP clinical and commercial drug substance manufacturing. Plus, our analytical methods development, validation, and testing are all done in-house.
Our Track Record
35+
Years experience in process development
25+
Years experience in GMP manufacturing
10+
Years experience in flexible, single-use manufacturing
85+
GMP batches released in the last 10 years
A Global Footprint
We are a single organization with a global network to deliver CDMO services across all stages of the molecule value chain.
A highly connected CDMO network to ensure speed, scalability, quality, and flexibility for monoclonal antibody, bi-specific antibody, fusion protein and antibody fragment development and manufacturing.
Our Shanghai site is home to our China Biologics Testing Center, which houses viral clearance suites. This enables clients to locally conduct viral clearance studies from pre-clinical development to commercialization for in China and for global export.
Our Martillac site was established in 1987 and has grown to a fully integrated site that offers process development and pilot production of up to 200L and GMP clinical and commercial production of up to 2000L.
Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Services include analytical development, cell banking, cell line characterization, viral clearance, drug substance and drug product release testing, as well as rapid methods.
Related Product Resources
- Why Choosing a Client-centric CTDMO is Critical when Outsourcing
This infographic discoveres 5 considerations, that are most critical as indicators of success.
- Trends in Outsourcing the Development and Manufacturing of Biologics
In this whitepaper, we share highlights from a global market research survey of small, midsized and large biopharmaceutical companies on trends related to outsourcing.
- A Molecule’s Journey Break Down Roadblocks to Clinical Success
A guidebook for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully bring a molecule to the clinic.
- Optimize the Formulation for a Monoclonal Antibody
This case study shows, how our innovative, custom solutions and decades of expertise allow to effectively balance cost, speed and risk when optimizing drug substance formulations in an accelerated timeframe.
- Reduce the Level of Host Cell Proteins in the Bioreactor Harvest
Learn how conceptualized and effective approaches help to address process development challenges such as HCP removal, in an accelerated timeframe.
- Scale your Process Directly from 3L to 2000L
In this case study we showcase how to advance a drug candidate into the clinic and ultimately onto the market faster.
- A Molecule’s Journey: Break Down Roadblocks to Commercial Manufacturing Success
A guidebook for today’s biopharma executives outlining key considerations to help ensure commercial manufacturing success.
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