Cell Therapy Processing (cGMP)

Cell therapies are processed in spatially segregated, dedicated ISO 7 (class 10,000) cell expansion rooms. The rooms contain biosafety cabinets, cold storage, CO2 incubators and centrifuges. If requested, our controlled rate cell freezer can be used to carefully freeze cells. Cells are stored in validated ultra-low liquid nitrogen vapor phase freezers which are continuously monitored.

Process development for cell therapy processes is available. Process development activities are carried out on our 5,000 sq. ft. laboratories in a building adjacent to the cGMP facility.

EXPERIENCE: Florida Biologix scientists have experience isolating, culturing and expanding primary cells, and can work with:

• Stem cells
• Lymphocytes (T-cells)
• Dendritic cells

We can process autologous or allogeneic material from various sources such as: whole blood, bone marrow, apheresis products, human tissues or cord blood.

Specialized or custom media and buffers can be prepared in-house.

All cells are manufactured and tested in compliance with cGMP regulations and FDA regulatory agency requirements. Tests may include sterility, surface markers, mycoplasma, functionality and viability.

Standardized procedures ensure no chance of mixing patient material. Our shipping experts make sure your released product is delivered viable and on your schedule.