Testing

Once the collected sample have been tested negatively for communicable diseases, it is then transferred to our laboratories and officially becomes the property of 23 Century. From this stage, 23 Century is responsible for each and every sample that is processed and provided to patients. The collected sample starts a second round of testing and while following donor’s requirement from the USFDA, AABB & CGMP 23 Century also carries out testing for cytomegalovirus, exogenous virus (human T-cell leukemia virus, HTLV), micro-organisms (aerobic bacteria, anaerobic bacteria, fungi, etc), survival rate, stem cell surface markers and stem cell biological characteristics (colony forming ability, differential capacity…) in each step to ensure the highest quality to its cell products.

Quality assurance inspection of stem cell packet by Beike technician
Quality assurance inspection of stem cell packet by 23 Century technician

Separation & Culturing

A centrifuge is used to separate stem cells. This is highly refined and specialized separation process. After separation has been completed, the stem cells are removed for culture.

The stem cells derived from each umbilical cord are seeded into a flask filled with culture medium. This medium does not contain any animal products (such as fetal calf serum) but it is enhanced with cell growth factors. The flasks are placed in a sterilized, temperature and humidity controlled incubator. The stem cells are expanded in the culture medium. Once the culturing is complete, the culture medium is washed away and are harvested.

Technician testing a Stem Cell packet at a 23 Century laboratory
23 Century laboratory

Storage

The cell products are then cryo-preserved and stored at a consistent -196 degree Celsius temperature with automatic supplement of liquid nitrogen. This technology allows for integrated control rate of freezing that totally avoids sudden drops in temperature. Our cryo-preservation storage equipment is also equipped with 24h real-time control system and in any case of power-failure or other emergency, a redundant fail-safe power supply ensures that normal operation is carried out. Our vacuum protection system can maintain proper temperature for 20 days without supplement of liquid nitrogen.