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
Princeton, New Jersey, United States, North America
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
Process & Analytical Development
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 Cell Banking & Drug Substance/Product Manufacturing
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.
Aseptic Fill & Finish and Final Product Packaging
Sterile filling into cryovials, bags and other containers with validated inspection and container closure integrity testing, labelling and controlled-temperature storage for distribution.
QC Lot Release & Stability Testing
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 Development and Pilot Runs
Non-GMP material generation for development, pilot and engineering runs to support process optimization, comparability testing, and preclinical material needs.
Technology Transfer, MSAT and Hybrid Client Models
Structured knowledge transfer, MSAT engagement, and client-in-plant operational models to convert development processes into reproducible GMP manufacturing operations.
Process & Analytical Development
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 Cell Banking & Drug Substance/Product Manufacturing
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.
Aseptic Fill & Finish and Final Product Packaging
Sterile filling into cryovials, bags and other containers with validated inspection and container closure integrity testing, labelling and controlled-temperature storage for distribution.
QC Lot Release & Stability Testing
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 Development and Pilot Runs
Non-GMP material generation for development, pilot and engineering runs to support process optimization, comparability testing, and preclinical material needs.
Technology Transfer, MSAT and Hybrid Client Models
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