Infrastructure
Infrastructure


A safe, economic and reproducible way of transporting cells is required if stem cell therapies are to enter the clinics and hospitals, benefit patients and become a reality. This must be done in such a way as to comply with FDR requirements, using a laboratory with appropriate ISO accreditation and a transport device that has appropriate 510k registration and an appropriate CE mark. It must enable consistent, efficient and cost effective transport between the site of production of the stem cells and the end user doctors and surgeons. Ideally there should be a direct line connecting producer and end user.

To ensure patient safety we believe that the processing center which receives the living cells must be under the control of qualified and registered professional persons and operate under strict Quality Assurance (QA) with Standard Operating Procedures (SOPs), a controlled sterile/aseptic environment, continuous validation of performance and a transparent audit trail.

We believe that the best way to do this is to establish Stem Cell Stations in side-rooms or Catheterization Laboratories and to make them satellite laboratories of established and accredited (AABB, FACT-Netcord, etc) stem cell banks. The Stem Cell Stations would have small HEPA filter cabinets, sterile procedures, a centrifuge, a microscope and other minimal equipment. They would comply with cGTP requirements (minimum manipulation of tissues). The accredited banks would provide back-up equipment, and qualified and registered staff for the Stem Cell Station. Autoclaves, balances and preparation of sterile reagents, stem cell expansion, CD antigen analyses, etc. would be done at the Stem Cell Bank. They would comply with cGMP requirements (good manufacting requirements). They could expand the options of the Stem Cell Stations.

A compact HEPA filter cabinet from Captair is shown below. The sides are made from transparent synthetic glass. Other cabinets have metal sides and UV lights in addition to the HEPA filter. Some cabinets have a metal frame construction. The Captair cabinet uses a H14 Hepa filter (99.995% for 0.3 microns) and a vertical flow. The filter meets ISO5 or a Class 100 requirements and is EN ISO 14644 compliant. It uses an air flow velometer to monitor filter performance. Such cabinets retail for between R24000-R40,0000.





We are manufacturing a similar cabinet with a H14 Hepa filter and UV and white lights. This will retail in South Africa for approximately R12,000 (excluding VAT).