mAb & r-Proteins Contract Testing, Development & 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.
Talk To an ExpertOur 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
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.
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.
mAbExpressTM Program - From Transfection to GMP Drug Substance in 9 Months
Our mAbExpress™ 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.
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.
Manufacturing
Clinical Drug Substance Manufacturing
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.
Commercial Drug Substance Manufacturing
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:
- Direct, efficient Tech transfers
- Validation Expertise
- CMC & Regulatory Support
- Single-use Equipment Knowledge
- Dedicated Manufacturing Science and Technology team
- Integrated Value Chain
QUALITY & REGULATORY SERVICES
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.
Quality and CMC Regulatory Support
- Robust Quality Management System
- GMP-compliant Quality Assurance
- CMC Regulatory Support for Drug Development and Manufacturing
- CMC Regulatory Support from Initial Filing to Post-Approval and Lifecycle Management
- Formatting of information to the Common Technical Document
Analytical Methods Development
- Cell bank characterization
- Analytical methods development, implementation, and validation
- In-process control testing
- Mass-spectrometry capabilities
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 offers pilot production up to 200L and GMP clinical production up to 2000L, for biopharma clients locally and globally. Our lab and production areas are equipped with the latest single-use technology and a biosafety testing facility offering viral clearance study services.
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.
With our 2022 expansion, we’ve doubled our process development and pilot production capacity, adding a brand-new seeding lab, two suites for 200L bioreactors, and a downstream processing area.
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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