Cell Therapy Development & Manufacturing CDMO

Process & Analytical Development

Advance from research to commercialization with scalable, reproducible processes and cutting-edge analytical methods.

Ready-use Platform Processes for Rapid Clinical Progress
- Standardized workflows for T-cell, NK-cell, iPSC, and TIL cell therapy manufacturing
- 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 Cell Banking
& Drug Product Manufacture

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
- (2) regional GMP facilities, conveniently located 40 miles away
- Flexible and regional workforce support for dual-site supply and demand
- (8) GMP production cleanrooms (ISO 7) with future expansion capacity
- Cleanrooms - US FDA, 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

GMP 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 (2025)

QC Lot Release & Stability

Ensure safety, potency, and quality with industry-leading 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 - sterilty, 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

Workforce Development & Training

Empowering the next generation of industry professionals through hands-on, GMP-aligned training programs.

Experiential Learning Center
- Convenient location in Newark, NJ (located at the New Jersey Institute of Technology)
- Hands-on and virtual training in a state-of-the-art learning environment to develop industry-ready skills
- Hybrid learning model combining classroom, virtual, and practical instruction
- Training programs led by Subject Matter Experts (SMEs) with real-world experience
- Ready-use and customizable modules to meet client-specific manufacturing and regulatory needs
Real-World Industry Application
- Access to state-of-the-art bioprocessing and analytical platforms for training
- Scalable training solutions for small teams and large-scale workforce programs
- Competency-based assessments to ensure workforce readiness
- Integration with Made Scientific’s GMP manufacturing and Process & Analytical Development center in Princeton, NJ

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 (2025)
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