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HomeServicesMillipore® Contract Testing, Development, and Manufacturing Organization (CTDMO) ServicesmAb & r-Proteins Contract Testing, Development & Manufacturing Services

mAb Development and Manufacturing Services

Biologics development and manufacturing

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.

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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


Monocloncal antibody and recombinant protein process development and purification

Development

Cell Line Development

Designing a cell line that expresses the gene of interest is a critical step in pre-clinical development. We help ensure our client’s cell line reliably produces high-quality proteins, from pre-clinical to commercial scale. Our proprietary CHOZN® cell line development platform allows for faster, simpler selection and scale-up of high-producing clones.

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.

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Early-Stage Process Development

As our clients move from cell line to upstream and downstream process development, we help build a robust, scalable process that brings success now and into the future. While we are constantly seeking to speed up the process, we help our clients meet quality, safety, and regulatory requirements for IND/IMPD filing.

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Accelerated mAb Development  Program – From Transfection to GMP Drug Substance in 9 Months

Our accelerated mAb development program shortens development timelines for IgG1 and IgG4 monoclonal antibodies to 9 months using a proven process that is phase-appropriate and cost effective. The program embodies our 35+ years of experience in mAb development and process knowledge, continuous innovation, high-quality standards, and risk mitigation, along with deep expertise in CMC and regulatory requirements.

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Late-Stage Process Optimization, Scaling, and Validation

As our clients transition to commercial biologic manufacturing, we offer late-stage capabilities to help prepare for production. Our multi-disciplinary team has 25+ years of experience in GMP manufacturing. We provide technology, equipment, and expert counsel to enable our clients to adapt, scale, and validate their manufacturing process to meet market demand.


CTDMO map

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.

Production Site - Shanghai, China
Shanghai, China

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.

Production Site - Martillac, France
Martillac, France

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.

Production Site - Rockville, United States
Rockville, United States

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.


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