Minaris Regenerative Medicine
Minaris Regenerative Medicine is a global leading Contract Development and Manufacturing Organization (CDMO) for Cell and Gene therapy products, with over 25 years of experience. The company is dedicated to creating future cell therapy miracles through high-value clinical and commercial manufacturing services, development solutions, and innovative technologies. With state-of-the-art facilities across the US, Europe, and Asia, Minaris serves more than 180 clients worldwide, supporting the development and manufacturing of advanced therapies to improve society's well-being.
Industries
Nr. of Employees
large (251-1000)
Minaris Regenerative Medicine
Haidgraben 5, 85521 Ottobrunn, Germany
Products
GMP Manufacturing
Comprehensive manufacturing services compliant with regional regulatory requirements for cell and gene therapies.
Development
Services to design efficient and robust manufacturing processes for cell and gene therapies.
Global Manufacturing Facilities
Six facilities across North America, Europe, and Asia for clinical and commercial manufacturing of cell and gene therapies.
Regulatory Compliance
GMP-compliant facilities with cryogenic storage, material management, and QC laboratories, adhering to regional regulations.
LYFGENIA™ Manufacturing
Commercial manufacturing of LYFGENIA, a gene therapy for sickle cell disease, at the Allendale, NJ site.
GMP Manufacturing
Comprehensive manufacturing services compliant with regional regulatory requirements for cell and gene therapies.
Development
Services to design efficient and robust manufacturing processes for cell and gene therapies.
Global Manufacturing Facilities
Six facilities across North America, Europe, and Asia for clinical and commercial manufacturing of cell and gene therapies.
Regulatory Compliance
GMP-compliant facilities with cryogenic storage, material management, and QC laboratories, adhering to regional regulations.
LYFGENIA™ Manufacturing
Commercial manufacturing of LYFGENIA, a gene therapy for sickle cell disease, at the Allendale, NJ site.
Services
Design and optimization of GMP-compliant manufacturing processes for cell and gene therapies, including material selection, process standardization, scale-up and batch record development.
Systematic transfer of technical knowledge, specifications, procedures and analytical methods from development partners into GMP manufacturing environments, with in-house adaptation and optimization to meet regulatory requirements.
End-to-end GMP manufacturing services for cell and gene therapy products at regional facilities supporting clinical and commercial supply, including cleanrooms, packaging and cryostorage.
Assay development, prequalification, transfer, validation, and release/in-process testing services including flow cytometry, PCR/ddPCR, ELISA, bioassays and microbiology.
Advisory services covering product characterization, regulatory CMC consulting, strategic development, financial modeling, technology evaluation and project management.
Qualified Person batch certification and EU import/release services for cell and gene therapy products manufactured for the European market.
Design and optimization of GMP-compliant manufacturing processes for cell and gene therapies, including material selection, process standardization, scale-up and batch record development.
Systematic transfer of technical knowledge, specifications, procedures and analytical methods from development partners into GMP manufacturing environments, with in-house adaptation and optimization to meet regulatory requirements.
End-to-end GMP manufacturing services for cell and gene therapy products at regional facilities supporting clinical and commercial supply, including cleanrooms, packaging and cryostorage.
Assay development, prequalification, transfer, validation, and release/in-process testing services including flow cytometry, PCR/ddPCR, ELISA, bioassays and microbiology.
Advisory services covering product characterization, regulatory CMC consulting, strategic development, financial modeling, technology evaluation and project management.
Qualified Person batch certification and EU import/release services for cell and gene therapy products manufactured for the European market.
Expertise Areas
- GMP clinical and commercial manufacturing for cell and gene therapies
- Technology transfer and process scale-up for ATMPs
- Analytical development and assay validation for cell therapies
- Bioprocessing and large-scale cell expansion
Key Technologies
- Flow cytometry
- Digital PCR and quantitative PCR
- ELISA
- Automated closed-system cell processing platforms
News & Updates
Participation in BioEurope Spring 2025 in Milan, Italy, a platform for networking and collaboration in biotech.
Participation in BioEurope Spring 2025 in Milan, Italy, a platform for networking and collaboration in biotech.