Influence of temperature during transport and storage of umbilical cord blood samples
The American Association of Blood Banks mentions that Umbilical Cord Blood (UCB), once regarded as biological waste, can now be used to bolster a patient’s immune system. These stem cells are used to treat malignant diseases such as leukemia and non-malignant diseases such as immune deficiencies, severe aplastic anemia, and congenital disorders such as sickle cell anemia and thalassemia.
Only the blood making cells in UCB are currently useful for transplant. After the delivery of a newborn, the umbilical cord is clamped and then cut. A needle is then used to draw the blood from the umbilical cord vein into a collection bag. Since this happens after delivery, there is no pain or risk to mother or infant. The UCB product is labeled and shipped to a facility for processing, freezing and storage. The volume collected varies but usually ranges from 50 to 200 ml (½ to 1 cup).
In the United States of America, The Food and Drug Administration (FDA) states in: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container at chapter VII, paragraph B9e: “We recommend that you transport cord blood in a shipping container designed to contain any leakage from the collection container and to minimize temperature changes during transportation.
In the UK, the Human Tissue Authority demands in the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment in the paragraphs regarding transport and packaging:“The transport conditions, including temperature and time limit, must be specified and validated.” “The shipping container must be able to maintain the tissues or cells in the specified conditions for safety and quality of the tissue or cells. Packaging must minimise the risk of contamination and must be able to preserve the tissue at the specified temperature for the maximum transit time that has been set. In order to maintain a high cell quality, donated whole cord blood (WCB) needs to be processed and cryopreserved as soon as possible.” In Germany, this must be done within 48 hours after donation. According to German national guidelines, a temperature of 22 ± 4°C must be maintained during that time.
J. Strobel, L. Brenner, R. Zimmermann, D. Weiss, J. Zingsem, R. Eckstein, V. Weisbach presented a study in their publication Clin. Lab. 2015;61:1453-1461
- As long as the temperature did not get colder than 8°C or warmer than 24°C, all cell types showed good viability.
- At a cut off of 12°C viability was significantly higher for colder temperature, and at 20°C it was significantly higher for warmer temperatures.
- Favour transport and storage at room temperature rather than cooled to 4°C prior to processing.
- CFU potential of CBUs transported and stored warm was higher than that of units transported
- Colder up to a cut off of 20°C, although this effect just missed statistical significance at temperature cut-offs of 16°C and 20°C.
- Most colleagues reported that storage and transport longer than 24 hours resulted in decreasing viability of especially CD45+ cells.
- Most of these studies showed good viability for CD34+ cells and colony forming unit (CFU) potential for up to 48 hours. Temperatures of either 4°C or 25°C mainly did not influence these findings
- Storage longer than 48 hours prior to processing and cryopreservation might lead to a reduced CFU potential.
Taking into account all experimental data the scientists concluded that the effect of temperature excursion is clinically negligible in a range from 4°C to 28°C if cryopreservation is done within 48 hours.
The Global Cord Blood Banking market is expected to grow from USD 16.88 billion in 2019 and to reach USD 25.90 billion by 2027, growing at a CAGR of 5.5% during the forecast period 2020-2027. The global cord blood banking market is expected to witness significant growth, owing to the increasing number of facilities, increasing use of cord blood in the treatment of chronic diseases, and rising prevalence of chronic diseases. This growth is attributed to the rising awareness about therapeutic applications of cord blood, government initiatives and funding in developed economies, increasing prevalence of life-threatening genetic diseases, and growing clinical trials in regenerative medicines. A growing number of investors and genetic disorders will propel the market for cord blood banking.
- Public cord blood bank segment dominated the market and held the largest market share of 58.2% in 2019
- Storage segment dominated the market and held the largest market share of 51.26% in 2019
- Blood disorders segment dominated the market and held the largest market share of 26.7% in 2019
- Research institute segment dominated the market and held the largest share of 41.5% in 2019
- North America held the major share of 25.8% in the year 2019
How is Akuratemp improving the safety of umbilical cord blood samples?
By understanding the physical constraints of cord blood collection kits and temperature control requirements during transportation of the collected samples, Akuratemp has developed a cord blood collection kit that can help cord blood testing and storage organizations meet the temperature control recommendations established by AABB.
“We have developed reliable, reusable, and traceable temperature-controlled packaging solutions that provide thermal security during transport of umbilical cord blood samples.” Harshul Gupta, Chief Technology Office at Akuratemp LLC
Akuratemp adopts a customized approach in developing Temperature-Controlled Packaging. Each solution is designed specifically for the biologics it carries and provides thermal security within tolerable ranges for the entire transporting journey. Akuratemp incorporates smart monitoring technology within each package to establish thermal traceability and rapidly identify any deviation.