Minaris Regenerative Medicine, LLC
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- Minaris - Cell Therapy Technology
Minaris - Cell Therapy Technology
At Minaris Regenerative Medicine, we are committed to bringing together and further developing highly talented, skilled, and dedicated experts with varied backgrounds applicable to gene and cell therapy manufacturing and development. Having this team creates the potential to accelerate your progress to market and to both anticipate and overcome your challenges, while reducing the overall cost and risk of your clinical and commercial development programs.
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We have extensive experience working with human cells in multiple therapeutic applications, for both autologous and allogeneic cell therapies.
Our Extensive Cell Therapy Manufacturing Experience
Cell Types
- Mesenchymal stem cells (MSC)
- Hematopoietic stem cells (HSC)
- T-Cells (CAR-T, TCR, Treg)
- Lymphocytes
- Monocytes
- Natural Killer cells (NK)
- Dendritic cells
- Induced pluripotent stem cells (iPSC)
- …and more
Manufacturing Procedures
- Cell isolation
- Cell selection
- Cell sorting
- Gene modification (viral vectors or CRISPR/Cas)
- Cell expansion
- Washing
- Volume reduction
- Formulation
- Cryopreservation
Analytical Methods
- Flow cytometry
- Bioassays
- PCR
- ELISA
- Microbiology
Analytical Development
- Release assays
- In process controls
- Characterization
- Potency assays
Manufacturing Development
- Starting material/procurement
- Automation/bioreactor/upscaling
- Genetic modification/vector optimization
- Fill & finish
Technologies
- 2D bioreactors (e.g. Pall xpansion® system)
- 3D bioreactors
- Automated systems
(e.g. Prodigy®) - Closed systems
- Fill and Finish
Regulatory Expertise
- cGMP and GMP compliance
- Clinical development
- Commercial manufacturing
- Transfer from one regulatory environment to another