GMP compartment (white room system)

GMP compartment (white room system)

Short description:​

The 150 sqm area meets all the requirements for processing biological materials under GMP (good manufacturing practice) conditions specific to the drug industry and other therapeutic products. This area includes 3 class A workplaces placed in Class B rooms (ISO 5), where environmental conditions are permanently monitored (minimum particle number, absence of any bacterial load, temperature, humidity, pressure, high performance, HEPA-like, air filtration) and access is strictly restricted for specialist staff.​

Main activities / techniques:

The extremely high standards of these spaces will ensure the following applications:

  • antitumor immunotherapy
  • the creation of personalized therapeutic combinations for cancer patients
  • innovative therapies in immune diseases
  • isolation and expansion of cell types with application in regenerative medicine under controlled conditions


Staff:

  • ​Coordinator: Gabriela Tanasie, MD, PhD
  • Responsible for quality control
  • Responsible for quality assurance
  • Responsible for production
  • Technician


Equipment:

  • Laminar flow hoods
  • CO2 Incubators
  • Refrigerators and freezers
  • Centrifuges
  • CliniMACS clinical cell separator
  • Freeze dryer
  • Grooming machine for bone tissue

Contact

Pius Branzeu Clinical Emergency Hospital
300723 Timisoara, Romania
156, Liviu Rebreanu Boulevard
info@oncogen.ro

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