GMP translation

Cell therapy products are subject to strict Good Manufacturing Practice (GMP) regulations, so they require specialized facilities, expert personnel, and dedicated resources to efficiently support GMP manufacturing. As a GMP-certified company, SABZ Biomedicals is specialized in the design and construction of cleanrooms, biological containment facilities and walk-in chambers for CAR T cell therapies that use state of art decontamination technologies. SABZ has started its educational, advisory, and therapeutic activities in this field with the help of highly experienced cellular therapists with specialist expertise quality management and international standards of GMP manufacturing. According to the need for research and clinical centers, the company is ready to provide consulting and implement services as follows:

  • Acquiring regulatory mandates enforced by national level agencies for CAR T cell manufacturing.
  • Design and construction of cGMP-compliant manufacturing infrastructure including cleanrooms.
  • Complete personnel training to work under full GMP conditions.
  • Qualification of the equipment, process and analytics for technology transfer.
  • Provision of cGMP space & modular Cleanrooms for rental purposes.