Smart Cells follow strict protocols during the collection, processing, and storage of samples, ensuring their viability and quality for future use.
The Smart Cells Laboratory uses state-of-the-art equipment designed to process and store cord blood as quickly and optimally as possible. All processing procedures are undertaken in a sterile, controlled environment by specially trained technical staff, using the industry standard system for cord blood processing – the Biosafe Sepax system. You can read more about our laboratory here: https://www.smartcells.com/our-laboratory/
Samples are regularly tested and validated for sterility and to ensure required stem cell counts and viable cell recovery. We run a number of tests during the processing. TNC stands for Total Nucleated Cells which are the white blood cells within a cord blood sample. Smart Cells count these cells as this is an important measurement of the success of the collection in terms of cell numbers. Within the TNC cell fraction, the Smart Cells team look at numbers of CD34 positive cells. This is a critical measurement as CD34 is a marker of stem cells. Both TNC and CD34 levels in a cord blood sample are taken into account by clinical teams when deciding if there are sufficient stem cells for treatment. Our storage criteria for CB are as follows:
Minimum blood volume: 10ml
TNC’s: 150 million
CD34+: 100,000
We undertake regular auditing of cord blood yields following processing and again after freezing and thawing processed cells. It is well recognised clinically that both the Total Nucleated Cell Count (TNC) and viable CD34+ stem cell doses in a cord blood unit following thawing for use are critical to successful clinical outcome.
Smart Cells also operate a clean room facility, adhering to GLP (good laboratory practice) and GMP (good manufacturing practice) practices. Also, Smart Cells have a cleaning SOP that all staff must follow to reduce and eliminate contaminants. The clean room is cleaned on daily basis, and benches and equipment cleaned in between samples. Laboratory technicians wear sterile coverall, sterile gloves, facemask, before they start processing samples. All consumables and samples packaging are sprayed cleaned with IPA before entering the cleanroom facility.