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End-to-End Cell Therapy CDMO Services

Together, we move forward faster.

We challenge the status quo with true partnership and shared investment in your program. Each project has a dedicated core team of subject matter experts led by an experienced project manager, plus flexible service models, agile processes, and cutting-edge technologies that keep your therapy on budget and on time, from early development to the clinic and beyond.

Operator in a full cleanroom gown and goggles hanging a bag on a cell processing system

Process & Analytical Development

Advance from research to commercialization with scalable, reproducible processes and proven analytical methods.

  • ReadyMADE™ Platform Processes for Rapid Clinical Progress

    • Standardized workflows for T cell, NK cell, MSC, Treg, iPSC-derived, and TIL therapies
    • Pre-existing master batch records & 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 & 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 & optimization of adherent and suspension cell cultures for clinical and commercial manufacturing
    • Gene modification & activation through electroporation, transduction, and optimized expansion protocols
    • Custom formulation & 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 readiness

  • Method Development, Transfer & Optimization

    • Development and validation of phase-appropriate and product-specific analytical methods for identity, potency, purity, and safety
    • Seamless internal method transfer from development to GMP-compliant QC laboratories
    • Support for comparability studies and assay bridging to ensure consistency across manufacturing sites

GMP and Non-GMP Manufacturing

Providing GMP-compliant manufacturing solutions to ensure regulatory compliance for autologous and allogeneic therapies.

  • GMP Cell Banking (RCB/MCB/WCB)

    • High-Quality, GMP-Compliant Banking of Master (MCB) and Working Cell Banks (WCB)
    • Continuous Cell Lines, Allogeneic, iPSC, and Primary tissue cell line establishment
    • Production in T/Shake flasks, Cell Stacks, Rocker Systems, Stir-tank Reactors (STR), and Perfusion Bioreactors
    • High cell concentration banks
    • Cell bank characterization & stability studies performed in-line with ICH guidelines
    • Long-term cryopreservation solutions with validated liquid nitrogen vapor-phase storage

  • GMP Manufacturing Facilities & Capability


    • (5) GMP production cleanrooms (ISO 7) with future expansion capacity
    • Cleanrooms: US FDA and Annex I compliance
    • Single-use technology and automated cell processing for scalable manufacturing
    • Comprehensive QC capabilities, including full testing and rapid-release methods
    • Kitting, material storage, and warehousing to support manufacturing needs
    • On-site QC laboratories and environmental monitoring for compliance and control
    • Stability storage, including LN2 cryo-storage units and cold-chain rooms
    • Ambient and cold-chain storage at 2-8°C, -20°C, -80°C, -145°C, and -180°C (LN2/vapor phase).

  • Storage, Logistics & Compliance

    • Comprehensive storage & warehousing for ambient, cold-chain, and cryogenic materials
    • GMP-compliant materials management, including incoming material inspection, release, and traceability
    • Qualified suite cleaning & changeover procedures
    • Qualified materials packing & shipping with validated cold-chain logistics
    • Certified documentation processes, including Chain of Identity (COI) and Chain of Custody (COC) compliance
    • Robust audit program, including annual self-audits and client inspections

Aseptic Fill & Finish

Move your cell therapy to the next phase with customizable and scalable aseptic fill & finish services.

  • Flexible Fill & Finish Capabilities

    • Filling of Cell Banks, Drug Substance, Drug Product, Placebo, and more
    • Qualified manual aseptic filling of cryovials (tubes, glass & polymeric vials)
    • Semi-Automated cryovial filling options
    • Semi-Automated filling into cryobags
    • 100% Visual Inspection (VI) on batch
    • Acceptable Quality Limit (AQL) performed
    • Primary and Secondary Labelling (as required)
    • Final storage of Drug Product

    Technologies Include: 
    • Terumo BCT FINIA™ Fill & Finish System
    • Fresenius Kabi LOVO®
    • Aseptic Technologies Crystal™ M1 Filling Station (2026)

Quality Control Testing & Stability Studies

Ensure safety, potency, and quality with rigorous analytical and quality control testing services.

  • Method Qualification & Validation

    • Phase-appropriate qualification and validation in alignment with ICH Q2(R1) guidelines
    • Analytical method robustness and accuracy assessments including specificity, linearity, precision, and range
    • Comparability and transfer studies to ensure consistency across different manufacturing sites
    • Ongoing method performance monitoring to maintain compliance and assay reliability

  • Lot / Patient Batch Release Testing

    • Comprehensive identity, potency, purity, and safety testing to meet regulatory requirements
    • Advanced analytical methods, including flow cytometry, qPCR/ddPCR, ELISA, cell-based assays
    • Rapid microbiological methods: sterility, mycoplasma, and endotoxin testing for timely product release
    • Full GMP documentation and batch record review for regulatory compliance

  • Stability Studies

    • Long-term, in-use, accelerated, in-process hold-time, and shipping studies to ensure product integrity
    • Cryopreservation assessments for liquid nitrogen and ultra-low temperature storage to maintain cell viability
    • Repeated freeze/thaw cycle testing to evaluate viability, potency, and functional recovery post-thaw
    • Customized stability protocols tailored to the unique requirements of autologous and allogeneic therapies.
    • Comprehensive stability protocols and reporting with Certificates of Analysis (CoA) to support regulatory submissions

Regulatory Consulting

Prepare for agency meetings and submissions, from early nonclinical studies through commercial approval worldwide.

  • Regulatory Strategy

    • Regulatory assessment and gap analysis for your development pathway
    • Eligibility evaluation for RMAT, Breakthrough Therapy, Fast Track, Orphan Drug, and EMA PRIME
    • Phase-appropriate, risk-based development planning
    • Ongoing monitoring of cell therapy guidance and what it means for your program

  • Agency Meetings

    • INTERACT, Pre-IND, End of Phase 1 and 2, Type B, and Type C meetings
    • EMA Scientific Advice and PRIME
    • Meeting requests, briefing books, and question and response strategy
    • Presentation rehearsal, attendance, and post-meeting next steps

  • IND, BLA, and CMC Submissions

    • IND preparation, including Modules 2 and 3, eCTD submission, and amendments
    • BLA strategy, Module 2 Quality Overall Summary, and Module 3 CMC documentation
    • CMC planning, critical quality attributes, comparability, and process validation strategy
    • Annual reports and post-marketing commitment planning

  • Support for First-Time Filers

    • Regulatory roadmaps tied to financing milestones
    • Academic-to-industry translation into compliant manufacturing
    • Right-sized quality systems and regulatory operations setup
    • Due diligence support for fundraising, partnerships, and licensing

  • Global Regulatory Strategy

    • FDA, EMA, PMDA, Health Canada, and MHRA requirements and submissions
    • One development strategy across regions, with region-specific requirements
    • Common Technical Document (CTD) preparation aligned with ICH guidelines

Workforce Development

Hands-on, GMP-aligned training for client teams and university partners.

  • Experiential Learning Center

    • Hands-on training in a working GMP environment, on the equipment and processes used for client programs
    • Hybrid learning model combining classroom, live-virtual, and practical instruction
    • Programs led by Subject Matter Experts who manufacture cell therapies every day
    • Custom curriculum for client teams, and credit-bearing coursework for university partners

  • Real-World Industry Application

    • Access to bioprocessing and analytical platforms used in cell therapy manufacturing
    • Custom cohort programs scoped per engagement, from a single team to a full site
    • Competency-based assessments to confirm workforce readiness
    • Integration with Made Scientific's GMP Manufacturing and Process & Analytical Development Centers

Equipment & Technology Platforms

State-of-the-art technologies to drive innovation, scalability, and efficiency in cell therapy manufacturing.

  • Cell Washing, Selection, Depletion, Harvest, Formulation

    • Fresenius Kabi LOVO®
    • Thermo Fisher Scientific Rotea™
    • Miltenyi Biotec CliniMACS Prodigy®
    • Miltenyi Biotec CliniMACS Plus®
    • Cytiva Sefia Select™

  • Cell Expansion & Bioreactor Systems

    • 2-D Systems (Wells, Flasks, Cell Stacks, G-Rex 10-500M)
    • Miltenyi Biotec CliniMACS Prodigy®
    • Miltenyi Biotec CliniMACS Plus®
    • Cytiva Xuri® Cell Expansion System
    • Terumo BCT Quantum Flex®
    • PBS-3 Vertical-Wheel Biorector
    • Sartorius Ambr® 15
    • Sartorius BIOSTAT® STR
    • Pall Allegro 50/200 
    • Pall iCELLis® nano/500

  • Gene Delivery Technologies

    • Viral (Retro/lentiviruses)
    • Non-viral (Plasmid, mRNA/LNP)
    • Thermo Fisher Scientific Neon® & Xenon™
    • Lonza 4D-Nucleofector®
    • MaxCyte®

  • Semi-Automated Fill & Finish Systems

    • Terumo BCT FINIA™ Fill & Finish System
    • Fresenius Kabi LOVO®
    • Aseptic Technologies Crystal™ M1 Filling Station (2026)

  • Analytical Technologies

    • 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

Insights

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Let’s Shape the Future Together

Ready to move your cell therapy from bench to bedside? No matter where you are in development, we’re here to help you take the next step.