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Build vs. Buy: The CDMO Decision That Could Make or Break Your Cell Therapy
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Expert Process & Analytical Development for Cell Therapies
At Made Scientific, we combine scientific expertise and innovative technology to speed up your path to market.
The Foundation for Faster, Smarter Cell Therapy Development
From early-stage optimization to GMP readiness, we focus on designing workflows and strategies that scale with your therapy and ensure it maintains critical quality attributes at every stage.
End-to-End Development to De-Risk and Accelerate Your Therapy
Successful cell therapies require reproducible processes and powerful analytical methods. Our process and analytical development teams work together to build manufacturing workflows and characterization tools that protect therapy quality throughout development and manufacturing.
- Comprehensive process development from early-stage through commercial readiness
- Design of Experiments (DoE) approach to optimize critical process parameters
- Development of robust, validated analytical methods for characterization and release
- Risk-based and phase-appropriate analytical development strategy
- Seamless technology transfer from development and non-GMP environments to GMP manufacturing and release
Expert-Guided Development That Moves Your Therapy Forward
Cell Therapy Focus
Deep expertise in developing diverse cell therapy modalities
Seamless Translation
Processes designed for efficient transfer to GMP manufacturing
Quality by Design
Systematic approach to process optimization and characterization
Regulatory Strategy
Development work aligned with regulatory expectations
Accelerated Timeline
Efficient development approaches that reduce time to clinic, or access to our ready made platform
Cost Management
Optimized workflows that improve yield and reduce COGS, along with consultative services available to develop a process in alignment with your product strategy
Smarter, Scalable Processes Built for Clinical and Commercial Success
Our systematic approach to process development includes risk assessment, Design of Experiments (DoE) methodologies, process analytical technology (PAT) evaluation and implementation, statistical analysis, and process modeling for continuous process verification.
Ready-Use Platform Processes for Rapid Clinical Progress
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Standardized workflows for T cells, NK cells, HSCs, MSCs, iPSCs, and TILs cell therapy manufacturing
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Pre-existing master batch records and SOPs
- Trained personnel with completed aseptic validation
- Reliable supply chain with pre-sourced Bill of Materials (BOM)
Process Optimization & Scalability
- System and bioreactor feasibility studies for scalable manufacturing
- Process development for closed-system, automated manufacturing platforms
- Optimization of transduction / transfection efficiency
- Optimization of cell washing, isolation, enrichment, activation, expansion, depletion, harvest, and formulation processes
Cell Wash, Isolation, Activation, Depletion, Gene Insert/Edit, Expansion, Harvest, & Formulation Studies
- Cell sourcing and donor selection for autologous and allogeneic therapies to ensure optimal starting material
- High-purity cell isolation using magnetic bead-based selection and flow cytometry (FACS) for precise enrichment or depletion
- Scalable expansion and optimization of adherent and suspension cell cultures for clinical and commercial manufacturing
- Gene modification and activation through electroporation, transduction, and optimized expansion protocols
- Custom formulation and media optimization to enhance cell viability, functionality, and stability
Cryopreservation Studies
- Optimized cryoprotectant formulations and controlled rate freeze protocols
- Cryopreservation solutions to support GMP compliance and clinical to commercial readiness
The Analytical Foundation for Regulatory-Ready Cell Therapies
Our analytical development services establish robust methods to characterize, monitor, and control your cell therapy throughout development and manufacturing.
- Method Development/Transfer/Optimization: Creating fit-for-purpose analytical methods
- Method Qualification: Demonstrating suitability for intended use
- Method Validation: Formal validation per ICH guidelines for release and stability testing
- Comparability Studies: Supporting process changes and technology transfers
- Reference Standard Development: Establishing and qualifying reference materials
- Identity Testing: Flow cytometry, immunophenotyping, genetic analysis
- Potency Assays: Functional assays, cell-based potency testing
- Purity Assessment: Residual host cell proteins, process impurities quantification
- Rapid Safety Testing: Sterility, endotoxin, mycoplasma, adventitious agents
- Stability Indication: Methods to monitor product degradation and shelf life
Technology Transfer and MSAT
Made Scientific's Manufacturing Science and Technology Transfer (MSAT) team ensures seamless transitions across development stages and between facilities:
Manufacturing Science & Technology (MSAT) Capabilities
- Process characterization and validation support
- Manufacturing deviation investigation and troubleshooting
- Continuous process verification and improvement
- Process knowledge management and technical documentation
- Scale-up and scale-out strategy development
- Process risk assessment and mitigation
Technology Transfer Services
- Comprehensive gap analysis between sending and receiving sites
- Development of detailed transfer protocols and success criteria
- Systematic knowledge transfer and personnel training
- Engineering runs and process performance qualification
- Comparability assessment and strategy
- Regulatory documentation and change management
Transfer Experience
- Process transfers from academic and research settings, or client CDMO to Made’s GMP manufacturing
- Method transfers between analytical laboratories
- Scale-up from development to clinical manufacturing
- Site-to-site transfers and Person-In-Plant (PIP) support
Technology That Powers Scalable, High-Quality Cell Therapy Manufacturing
Made Scientific leverages state-of-the-art technology and equipment for comprehensive cell therapy process development.
Cell Washing, Selection, Depletion, Harvest, Formulation
Automated systems for washing, concentrating, selecting and formulating cell populations with high recovery and viability.
- Fresenius Kabi LOVO®
- Thermo Fisher Scientific Rotea™
- Miltenyi Biotec CliniMACS Prodigy®
- Miltenyi Biotec CliniMACS Plus®
- Cytiva Sefia Select™
Cell Expansion & Bioreactor Systems
A range of scalable platforms and systems to support cell growth and expansion, from early R&D to clinical and commercial manufacturing, with flexible formats.
- 2-D Systems (Wells, Flasks, Cell Stacks, G-Rex 10-500M)
- Miltenyi Biotec CliniMACS Prodigy®
- Cytiva Xuri® Cell Expansion System
- Terumo BCT Quantum Flex®
- PBS-3/15 Vertical-Wheel Bioreactor
- Sartorius Ambr® 15
- Sartorius BIOSTAT® STR
- Pall Allegro 50/200
- Pall iCELLis® nano/500
Gene Delivery Technologies
Versatile viral and non-viral systems for introducing genetic material into target cells across a variety of therapeutic areas.
- Viral (Retro/lentiviruses)
- Non-viral (Plasmid, mRNA/LNP)
- Thermo Fisher Scientific Neon® & Xenon™
- Lonza 4D-Nucleofector®
- MaxCyte®
Semi-Automated Fill & Finish Systems
Closed, scalable systems that streamline final formulation and aseptic filling processes.
- Terumo BCT FINIA™ Fill & Finish System
- Xiogenix ARES™ X20 Fill & Finish
- Fresenius Kabi LOVO®
- Aseptic Technologies Crystal™ M1 Filling Station (2025)
Analytical Technologies
A comprehensive suite of process and release-testing tools for identity, potency, purity and safety.
- ChemoMetec NucleoCounter® NC-200/202™
- Beckman Coulter CytoFLEX®
- Thermo Fisher Scientific QuantStudio™
- Bio-Rad QX200™ Droplet Digital PCR (ddPCR™)
- Charles River EndoSafe® nexgen-PTS™
- bioMérieux BACT/ALERT®
- bioMérieux BioFire® FilmArray®
- Thermo Fisher Scientific Varioskan™ Lux
- Beckman Coulter Vi-CELL BLU™
- Nova Biomedical BioProfile® FLEX2
Automated systems for washing, concentrating, selecting and formulating cell populations with high recovery and viability.
- Fresenius Kabi LOVO®
- Thermo Fisher Scientific Rotea™
- Miltenyi Biotec CliniMACS Prodigy®
- Miltenyi Biotec CliniMACS Plus®
- Cytiva Sefia Select™
A range of scalable platforms and systems to support cell growth and expansion, from early R&D to clinical and commercial manufacturing, with flexible formats.
- 2-D Systems (Wells, Flasks, Cell Stacks, G-Rex 10-500M)
- Miltenyi Biotec CliniMACS Prodigy®
- Cytiva Xuri® Cell Expansion System
- Terumo BCT Quantum Flex®
- PBS-3/15 Vertical-Wheel Bioreactor
- Sartorius Ambr® 15
- Sartorius BIOSTAT® STR
- Pall Allegro 50/200
- Pall iCELLis® nano/500
Versatile viral and non-viral systems for introducing genetic material into target cells across a variety of therapeutic areas.
- Viral (Retro/lentiviruses)
- Non-viral (Plasmid, mRNA/LNP)
- Thermo Fisher Scientific Neon® & Xenon™
- Lonza 4D-Nucleofector®
- MaxCyte®
Closed, scalable systems that streamline final formulation and aseptic filling processes.
- Terumo BCT FINIA™ Fill & Finish System
- Xiogenix ARES™ X20 Fill & Finish
- Fresenius Kabi LOVO®
- Aseptic Technologies Crystal™ M1 Filling Station (2025)
A comprehensive suite of process and release-testing tools for identity, potency, purity and safety.
- ChemoMetec NucleoCounter® NC-200/202™
- Beckman Coulter CytoFLEX®
- Thermo Fisher Scientific QuantStudio™
- Bio-Rad QX200™ Droplet Digital PCR (ddPCR™)
- Charles River EndoSafe® nexgen-PTS™
- bioMérieux BACT/ALERT®
- bioMérieux BioFire® FilmArray®
- Thermo Fisher Scientific Varioskan™ Lux
- Beckman Coulter Vi-CELL BLU™
- Nova Biomedical BioProfile® FLEX2
Seamless Integration for a Smoother Path to the Clinic
Our process and analytical development services are fully integrated with our broader CDMO capabilities, GMP manufacturing, quality control, and regulatory support. This connected approach accelerates timelines, reduces risk, and positions your therapy for long-term success.
- Technology Transfer: Smooth transition from development to GMP manufacturing
- Quality Control: Implementation of developed methods for product testing
- Regulatory Support: Development documentation for regulatory submissions
- Manufacturing Sciences: Ongoing process optimization and troubleshooting
- Stability Studies: Implementation of stability-indicating methods
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Comparability Assessment: Support for process changes and facility transfers
Accelerate Your Cell Therapy Development
Connect with our experts to design a development strategy tailored to your therapy, timeline, and regulatory goals.
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