GMP compartment

Short presentation:
An area of 150 sqm will enable the processing of biological materials in standard GMP (good manufacturing practice) conditions, specific for drug and other therapeutics industry. The area includes 3 working spaces class A placed in B class (ISO 5) rooms, where the environment parameters are strictly monitored (particle number, bacterial contamination, temperature, pressure, humidity, air filtering through HEPA systems, etc.) and the access is restricted only for specialized personnel.

Main activities/techniques:
The use of these high standards areas is intended mainly for:

  • antitumor immune-therapy
  • preparing personalized therapeutic mixtures for cancer patients
  • innovative therapies in immune diseases
  • isolation and expansion in strictly controlled condition of various cell types with potential applications in regenerative medicine

Personnel:
Coordinator: Gabriela Tanasie, MD, PhD
Responsible for quality control
Responsible for quality assurance
Production responsible
Technician

Equipment:

  • Laminar flow hoods
  • CO2 incubators
  • Refrigerators and freezers
  • Centrifuges
  • Clinical grade cell separator – CliniMACS
  • Lyophilization unit
  • Grinder for bone tissue

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