Quality Policy

Jeevan Public Cord Blood Bank, established in 2007, is a unit of 20 year old not for profit, Jeevan Blood Bank and Research Centre. The mission of Jeevan is to enable quick and affordable access to high quality stem cells from donated cord blood for transplant to Indians. Jeevan is the largest active public cord blood bank in the SAARC region.

Jeevan has over 4150 units of stem cells from donated cord blood and our target is to reach10,000 before March 2017. It complies with the national standards laid down by the DCGI. In addition, the project is certified to ISO 9001:2008 standards. Though not yet accredited, all systems compy with Netcord FACT standards .

The process and storage

To ensure the highest quality of the product, Jeevan pays critical attention to all aspects of processing like collection, packing, transportation, harvesting stem cells, cryopreservation stem cell units.
Once we receive the cord blood units, we process and categorise to decide fitness for clinical use. All units must reach our lab within 40 hours ( outermost of 44 hrs ) from the time of collection. Further decision to process depends on the number of
TNC (Fig 1)

  • All units are processed with the Sepax S100 automated cell processing system.
  • The testing of each cord blood unit includes: blood grouping, HLA typing (SBT), Infectious Disease Marker testing for HIV, HBV, HCV by Nucleic Acid Testing (NAT), Malaria, Syphilis, bacterial and fungal culture, Haemoglobinopathy screening, cell counts (total nucleated cells and CD34+ cells), CFU and viability.
  • Mother’s blood sample is tested for HIV-1 & 2, HTLV-I & II, HBsAg, HCVAb, Syphilis, Malaria and CMV.
  • Temperatures within the tanks are monitored continuously and are equipped with an automated recording system. Maximum temperature registered in the warmest part of the tank never exceeds -150°C and after retrieval and transfer not higher than -135°C.

Criteria for release of a unit

In order to obtain the highest quality product Jeevan’s CBU must meet the following minimum requirement to be validated and transferred to the register:

  • Total nucleated cells count prior to processing must be more than 60×107.
  • Total viable CD34+ cells count prior to cryopreservation must be more than 2.4 X 106
  • Viability of CD45+ cells must be higher than 85% prior to cryopreservation.
  • Sterile for bacteria and fungi.
  • Haemoglobinopathy testing by capillary electrophoresis is negative for abnormal haemoglobin.
  • Cord Blood negative for HIV, HCV, HBV by NAT, Malaria, Syphilis
  • Maternal blood negative for HIV-1 & 2, HTLV-I & II, HBsAg, HCVAb, Syphilis, Malaria and CMV (If CMV Ab positive the transplant team is notified before releaase).
  • HLA typing by SBT for A, B, C, DRB1and DQB1.
  • CBU must have at least 3, attached segments. Each segment usually contains between 70-100μL to provide adequate amounts to perform HLA typing and future testing which may include viability, cell counts, CFU, or IDMs.