Process & Analytical Development for Cell Therapies
Development That Carries Into GMP Manufacturing
You get process and analytical development teams that work together, and with the manufacturing, quality control, and regulatory teams that come next. Processes are designed to scale, using Design of Experiments and quality by design, and methods are developed to be qualified and validated, so both move into GMP without starting over.
Cell Therapy Focus
Development across T cells, B cells, NK cells, HSCs, MSCs, iPSCs, TILs, and exosomes
Quality by Design
DoE studies that define critical process parameters and how they affect quality attributes
Phase-Appropriate Analytics
Characterization and release methods that mature with the program
Ready for Transfer
Processes and methods designed to move into GMP manufacturing and QC
A Faster Start
ReadyMADE™ platform processes for programs that can start from a proven process
Lower Cost of Goods
Yield and workflow improvements that reduce COGS
Scalable Process Development
Our approach combines risk assessment, Design of Experiments, process analytical technology (PAT), statistical analysis, and process modeling for continuous process verification.
Optimization and Scale-Up
- System and bioreactor feasibility studies
- Process development for closed, automated platforms
- Transduction and transfection efficiency
Unit Operations
- Cell sourcing and donor selection for autologous and allogeneic therapies
- Isolation and enrichment by magnetic bead selection and FACS
- Expansion of adherent and suspension cultures, from clinical to commercial scale
- Gene modification by electroporation and transduction
- Formulation and media optimization for viability, function, and stability
Cryopreservation
- Cryoprotectant formulation and controlled-rate freezing protocols that support GMP and commercial readiness
ReadyMADE™ Platform Processes
- Pre-existing master batch records and SOPs
- Trained personnel with completed aseptic validation
- A pre-sourced bill of materials
Analytical Development
Your methods are developed to characterize, monitor, and control your cell therapy, then qualified and validated for release and stability testing.
- Method Development, Transfer, and Optimization: fit-for-purpose methods
- Method Qualification: shown suitable for intended use
- Method Validation: per ICH guidelines, for release and stability testing
- Reference Standards: established and qualified reference materials
- Identity: flow cytometry, immunophenotyping, and genetic analysis
- Potency: functional and cell-based assays
- Purity: process-related impurities
- Safety: sterility, endotoxin, mycoplasma, and adventitious agents
- Stability-Indicating Methods: to track product degradation and shelf life
Technology Transfer and MSAT
Our Manufacturing Science and Technology (MSAT) team moves processes between development stages, between sites, and between companies.
MSAT
- Process characterization and validation support
- Deviation investigation and troubleshooting
- Continuous process verification and improvement
- Scale-up and scale-out strategy
- Process risk assessment and mitigation
- Process knowledge management and technical documentation
Technology Transfer
- Gap analysis between sending and receiving sites
- Transfer protocols and success criteria
- Knowledge transfer and operator training
- Engineering runs and process performance qualification
- Comparability assessment and strategy
- Change management and regulatory documentation
Transfer Experience
- From academic labs or another CDMO into Made Scientific’s GMP manufacturing
- Analytical method transfers between laboratories
- Scale-up from development to clinical and commercial manufacturing
- Site-to-site transfers with Person-In-Plant support
Equipment for Scalable Cell Therapy Development
The platforms behind our process and analytical development work, grouped by step.
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 (2026)
Analytical Technologies
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 (2026)
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
Accelerate Your Cell Therapy Development
Tell us where your process stands today. We’ll scope the development work to get it ready for GMP manufacturing.