For EquiCord, the safety and quality of their product is a fundamental premise. Therefore we perform, along the whole process, 5 quality controls that ensure the functionality and safety of the cells.
First quality control or Reception
Upon receipt of the sample, laboratory staff verifies that the package has arrived in good condition, that the sample was sent correctly by following the KIT’s instructions and that the cold chain has been maintained throughout transport.
Second quality control or Pollution:
In this quality control, an analysis of the samples is done by PCR to verify that they are not contaminated by bacteria or fungi, including mycoplasma.
PCR amplifies the DNA strand of the microorganisms if they are present. It is one of the most precise techniques to detect very low concentrations of bacteria and fungi.
This analysis, for further safety, is done by an external company, which will issue a report attached to the client’s dossier.
Third quality control or Tissue Differentiation:
With this control we want to ensure the purity of our cells.
To do this, three representative samples obtained from the umbilical Stem Cells will be taken and each sample of cells will be forced to differentiate into a type of tissue: adipose, chondrogenic or osteogenic.
Once the differentiation takes place (process that takes about two weeks) an external laboratory to EquiCordwill analyze the samples and issue a report confirming that the differentiation has been made successfully to the desired tissues. This report will be forwarded to the client.
Fourth quality control or Microbiology:
This quality control ensures, according to the strictest regulations of the European Medicines Agency, the sterility of our product.
To carry out this quality control, a sample is taken from each of the vials and prepped for the cryopreservation process. An external company subjects the cells to a 14-day culture media for specific fungi and bacteria at 37.5 ° C as set by the guidelines of the European Medicines Agency.
If after these 14 days, no bacterial growth has been observed, sterility and safety of the product can be guaranteed.
With these results, a report will be issued and attached to the client’s record. A copy will be sent along with the other documentation for their cells.
Fifth quality control or Defrost:
In this last quality control, just before shipping the sample to the client after thawing, we verify that the process of freezing and thawing did not damage the cells, proving their viability and survival.