Research and development

For relevant protocols and procedures within the Center of Cell and Gene Therapy Stem Cell Bank «POKROVSKI» has been developed to comply with cGMP requirements. In addition to covering all stages of production, namely collection, processing, storage and release, it also addresses the following elements: equipment (purchase, use, and maintenance); materials (specifications, quarantine, and release); and quality systems (quality control, validation, and document control).

• Harvesting, Aphresis Collection
  - fully-equipped four-room apheresis suite.

• Cell Processing Center
  The Cell Processing Center is the most tangible aspect of a Center facility and it must conform to a variety of requirements to meet the demands of GMP. The total space of these laboratories occupies approximately 350 m2. Production is undertaken in four Class 10,000 (ISO5, Class 350) fully-equipped cleanrooms containing Class 100 (ISO7, Class 3.5) workstations. These rooms are designed to facilitate flexible, protocol-specific configurations. The rooms can operate independently under positive or negative pressure and the facility meets all physical containment level 3 (PC3) international standards.

  

• Cryopreservation
  - three workspace suitable for simultaneous processing of bio-materials
  - two rate-controlled freezers

  

 

• Support Infrastructure

• Patient recruitment

• Research Laboratories

• Clinical interpretation

• Statistical center

• The Center of Cell and Gene Therapy Stem Cell Bank «POKROVSKI» staffing is detailed in the organizational chart, which conforms to cGMP requirements. Specifically, there is a production arm that includes Center of Cell and Gene Therapy Stem Cell Bank «POKROVSKI» staff in apheresis, cryopreservation, and the cell manipulation laboratories. To maximize flexibility, we staff the cell anipulation laboratories with hospital pharmacy technicians who have additional cell manipulation training and are employed on an ‘as needed’ basis.