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.Talk To an Expert
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.
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.
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.
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.
Our multi-disciplinary team has more than three decades of experience with a wide range of biologic molecule types – providing technology, equipment, and expert counsel our clients can trust. Since 2012, we have used single-use technology to produce pilot and GMP batches in scales from 200L to 2,000L and have released 85+ GMP batches.
We provide commercial drug substance supply globally from our commercial facility in Martillac, France. Our dedicated CMC, regulatory, and quality experts will provide continuity from clinical to commercial manufacturing for routine large-scale manufacturing and small volume manufacturing.
As a fully integrated CTDMO partner, we offer:
From the earliest stages of development, and in parallel with analytical development, we collect, validate, and record data supporting both product quality and process robustness.
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.
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