Our Cell Therapy Manufacturing Expertise

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.  

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/ventor 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