Made Scientific
US-based cell therapy contract development and manufacturing organization providing end-to-end services from process and analytical development through GMP and non-GMP manufacturing, aseptic fill & finish, lot release testing, and workforce training. Operates multiple New Jersey facilities with ISO-classified cleanrooms, analytical laboratories, single-use and closed automated production platforms, and integrated digital manufacturing systems to support autologous and allogeneic programs from preclinical through commercial stages.
Industries
Nr. of Employees
small (1-50)
Made Scientific
201 College Road East, Princeton, NJ 08540
Products
Cell Therapy Development & Manufacturing
Provides development and GMP manufacturing services for autologous and allogeneic cell therapies across clinical phases and commercial stages.
Process & Analytical Development
Develops scalable, reproducible manufacturing processes and analytical methods for cell therapies to support clinical and commercial production.
GMP Cell Banking & Drug Product Manufacture
Provides GMP-compliant cell banking and drug product manufacturing for autologous and allogeneic cell therapies.
GMP Aseptic Fill & Finish
Offers customizable aseptic fill and finish services for cell banks, drug substances, and drug products in various container formats.
QC Lot Release & Stability Testing
Conducts quality control testing and stability studies to ensure safety, potency, and regulatory compliance of cell therapy products.
Workforce Development & Training
Provides hands-on and virtual GMP-aligned training programs to develop skilled professionals for cell therapy manufacturing.
Cell Therapy Development & Manufacturing
Provides development and GMP manufacturing services for autologous and allogeneic cell therapies across clinical phases and commercial stages.
Process & Analytical Development
Develops scalable, reproducible manufacturing processes and analytical methods for cell therapies to support clinical and commercial production.
GMP Cell Banking & Drug Product Manufacture
Provides GMP-compliant cell banking and drug product manufacturing for autologous and allogeneic cell therapies.
GMP Aseptic Fill & Finish
Offers customizable aseptic fill and finish services for cell banks, drug substances, and drug products in various container formats.
QC Lot Release & Stability Testing
Conducts quality control testing and stability studies to ensure safety, potency, and regulatory compliance of cell therapy products.
Workforce Development & Training
Provides hands-on and virtual GMP-aligned training programs to develop skilled professionals for cell therapy manufacturing.
Services
Development and optimization of scalable manufacturing processes and analytical methods to define CQAs, CPPs, and potency assays, with internal transfer to GMP QC laboratories.
GMP master and working cell bank creation and GMP drug substance and drug product manufacturing across clinical and commercial scales using single-use and closed-platform production.
Sterile filling into cryovials, bags and other containers with validated inspection and container closure integrity testing, labelling and controlled-temperature storage for distribution.
Comprehensive QC testing for identity, purity, potency and safety; rapid-release microbiological methods; and fully documented stability programs to support batch release and regulatory filings.
Non-GMP material generation for development, pilot and engineering runs to support process optimization, comparability testing, and preclinical material needs.
Structured knowledge transfer, MSAT engagement, and client-in-plant operational models to convert development processes into reproducible GMP manufacturing operations.
Development and optimization of scalable manufacturing processes and analytical methods to define CQAs, CPPs, and potency assays, with internal transfer to GMP QC laboratories.
GMP master and working cell bank creation and GMP drug substance and drug product manufacturing across clinical and commercial scales using single-use and closed-platform production.
Sterile filling into cryovials, bags and other containers with validated inspection and container closure integrity testing, labelling and controlled-temperature storage for distribution.
Comprehensive QC testing for identity, purity, potency and safety; rapid-release microbiological methods; and fully documented stability programs to support batch release and regulatory filings.
Non-GMP material generation for development, pilot and engineering runs to support process optimization, comparability testing, and preclinical material needs.
Structured knowledge transfer, MSAT engagement, and client-in-plant operational models to convert development processes into reproducible GMP manufacturing operations.
Expertise Areas
- Cell therapy process and analytical development
- GMP cell banking and clinical-to-commercial manufacturing
- Aseptic fill & finish and drug product release testing
- Analytical method development and validation
Key Technologies
- Vertical-wheel and stirred single-use bioreactors
- Single-use closed automated cell processing platforms
- Magnetic bead-based cell selection and enrichment
- Electroporation and nucleic-acid transfection platforms
News & Updates
Industry conference connecting bio/pharma companies and suppliers.
Conference covering latest developments in cell and gene therapy.
Manufacturing partnership to support a first-in-human mitochondrial therapy program.
Initial validation and plans for GMP integration of AI-enabled robotic manufacturing in live cell therapy production.
Technology partnership to advance T cell therapy manufacturing workflows.
Partnership to validate and scale a nanomechanical non-viral gene delivery platform for T cell and iPSC processes.
Industry conference connecting bio/pharma companies and suppliers.
Conference covering latest developments in cell and gene therapy.
Manufacturing partnership to support a first-in-human mitochondrial therapy program.
Initial validation and plans for GMP integration of AI-enabled robotic manufacturing in live cell therapy production.
Technology partnership to advance T cell therapy manufacturing workflows.
Partnership to validate and scale a nanomechanical non-viral gene delivery platform for T cell and iPSC processes.