Cell and Tissue Processing

  • Standard operating procedures to obtain properly biological material, according to current regulations and GMPs.
  • Tissue processing (including bone marrow, peripheral blood, etc.)
  • Mechanical and enzymatic digestion, immunoselection, cell depletion, etc.

Cell and Tissue Culture

  • Isolation, culture and harvest of human cells (primary cultures and cell lines; suspension or adherent cells; differentiated cells and stem cells).
  • Cell culture in Normoxia or Hypoxia conditions.
  • Custom manufacturing of cell therapy medicinal and tissue engineered products.
  • Batch production record and cGMP documentation development.

Storage, Distribution and Delivery

  • Final product formulation for cell based therapies (autologous or allogeneic).
  • Primary packaging: pre-filled syringes, glass vials, cryovials, bags and bottles.
  • Labelling of final container with customized label
  • Cryopreservation and cell banking of final product under GMP conditions (in clean rooms).
  • Controlled storage at different temperatures -20ºC, -85°C or -196°C.
  • Logistical services and shipping validation protocols for advanced therapy products.
  • Completely secure point-to-point chain of control and custody.
  • Ideally, full real-time package tracking.