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Advanced Cell Therapy Manufacturing for Every Stage of Your Product Lifecycle
Lay the foundation for clinical and commercial success, starting with the right manufacturing strategy.
Cell Therapy Manufacturing, Designed for the Future
At Made Scientific, we understand that successful cell therapies begin with well-designed, reproducible manufacturing processes. As your CDMO partner, we provide GMP and non-GMP manufacturing services tailored to the unique requirements of cell-based therapies.
Our integrated approach streamlines the path from development through commercialization, while maintaining product quality, high standards, and regulatory compliance.
The Infrastructure and Expertise to Move You Forward
Made Scientific was purpose-built for cell therapy, from our facilities to our team. We offer specialized, scalable manufacturing solutions designed to meet the complex needs of cell-based therapies.
- GMP and non-GMP manufacturing capabilities
- Customizable solutions, from clinical to commercial production
- Specialized expertise across a broad range of cell types and modalities
- Comprehensive environmental monitoring, quality control, and quality systems
- Regulatory compliance with FDA, EMA, and other global standards
Manufacture With Confidence
Made Scientific combines deep cell therapy expertise with scalable infrastructure, helping you reduce timelines, control costs, and maintain regulatory compliance from start to finish.
Focused Expertise
Specialized solely on cell therapy manufacturing across multiple modalities (T Cells, NK Cells, HSCs, MSCs, iPSCs, TILs, and more)
Flexible Capacity
Manufacturing solutions that scale with your product development pipeline, end-to-end capable facilities & static culture and semi- and fully-automated bioprocess technologies
Every Stage of Need
Non-GMP material generation for product development, as well as clinical-to-commercial enabling manufacture
Quality Assurance
Robust quality systems for both GMP and non-GMP operations
Accelerated Timelines
Optimized workflows that reduce manufacturing time without compromising quality
Customized Approach
Tailored manufacturing processes designed for your specific cell therapy
Regulatory Readiness
GMP documentation designed to support your regulatory submissions
From Batches to Breakthroughs: Facilities that Deliver
Our GMP manufacturing services provide compliant, high-quality production of cell therapy products for clinical trials and commercial supply.
Made Scientific's facilities feature:
- Dedicated Cleanrooms: ISO 7 manufacturing suites with ISO 5 processing areas
- Scalable Production: Capabilities spanning from small-scale clinical batches to commercial manufacturing
- Full Process Controls: Comprehensive environmental monitoring and contamination control
- Electronic Batch Records: Digital documentation ensuring complete traceability
- Cell Processing Expertise: Specialized in handling primary cells, stem cells, and genetically modified cell products
- Quality Testing: In-process and final product testing, including rapid release technologies and methods
- Cryopreservation: Controlled-rate freezing and storage capabilities
Non-GMP Manufacturing
Our non-GMP manufacturing services provide an efficient and cost-effective approach to manufacture of material for early-stage development, process optimization, and other non-clinical studies. These services maintain high-quality standards while offering greater flexibility and faster timelines.
Applications include:
- Process development and optimization
- Materials for analytical method development
- Pilot runs and engineering batches
- Material for preclinical studies
- Technology transfer preparation
- Operator training and capability building at Workforce Development & Training Center in Newark, NJ
Advanced Cell Processing Technology and Equipment
Made Scientific leverages cutting-edge technology and specialized equipment designed specifically for cell therapy manufacturing:
Cell Washing, Selection, Depletion, Harvest, Formulation
- Fresenius Kabi LOVO®
- Thermo Fisher Scientific Rotea™
- Miltenyi Biotec CliniMACS Prodigy®
- Miltenyi Biotec CliniMACS Plus®
Cell Expansion & Bioreactor Systems
- 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 (2-10L)
- Pall Allegro 50/200L
- 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)
Ready to Accelerate Your Cell Therapy Manufacturing?
Partner with Made Scientific for manufacturing solutions tailored to your therapy. Connect with our team to design a customized approach that fits your timeline, product, and goals.