The science of biotechnology typically relies on the reproducibility of the results; in order to confirm it to be a discovery. If preceding information is not repeatable, it is uncertain that any scientist or researcher will continue to pursue that work. Much of biomedical studies—medicine, genetics, drug discovery, vaccine development, reconstructive medicine, fundamental science, HIV testing/treatment, and cell biology—is accomplished using cultured primary cells received from various primary repositories or fellow researchers. It is predicted that 15–20% of the time, cells utilized in experiments have been misidentified or cross-contaminated with some other cell type.
Aside from the problem of unreliable or questionable information, cross-contamination additionally wastes time and money. For example, if it is estimated that 18-36% of primary cells utilized in clinical studies are either misidentified, duplicated, or cross-contaminated, it makes the studies’ results invalid. In addition, the economic value of invalid research resulting from misidentified primary cells has been anticipated to exceed $50 billion, by the end of 2021. The cost of ignoring authentication is not just money, more than 32,000 papers have been discovered based on misidentified primary cells. Drugs, vaccines, and different biomedicines all are created primarily based on findings in the lab, generally via cell culture. Products made using misleading or false information can cause major delays in the manufacturing and availability of treatments for numerous ailments. The longer it takes for a treatment to be developed, the more individuals these ailments affect; and probably the more is the socio-economic burden on the countries. Thus, the authentication of primary cells that will be used as therapeutic modalities is of utmost importance.
This is often achieved via the usage of phenotyping and technology having the ability to assess identification to the species level (e.g., isoenzyme analysis and/or karyotyping). This authentication paradigm on its own cannot offer a guarantee that an appropriate human cell preparation is administered, so careful labeling and monitoring of cells from the manufacturer’s end, quality control of the entire batch are essentially important to be the best in class. Accurate identification of a batch by maintaining its donor profile can significantly reduce the chances of misidentified cells or mixed populations. The availability of a standardized approach for accomplishing this could offer a way to enhance the protection profile of primary cell-based products by presenting assurance that the given lot of cells originated from the intended donor and were not inadvertently mixed or replaced with cells from different donors. To assist with this goal, an international group of scientists has organized consensus standards that are to be followed, before authentication of human cells using short tandem repeat profiling.
Short tandem repeat profiling is an analytical DNA approach that relies upon the simultaneous amplification of multiple stretches of polymorphic DNA inside a single vessel.
- Repetitive DNA sequences with varying numbers of repeats called STR loci are amplified by the usage of primers with differently coloured fluorophores.
- The resulting stretches of amplified DNA are distinguished via both size and colour and are separated on a genetic analyzer with a software program being used to investigate the resulting data.
- The STR data (profile) from the cell specimen under assessment can be compared with formerly generated profiles for that particular cell type as a method of authenticating the identity of the cell specimen.
STR profiling is fast and economical, and since the output is constant between laboratories, the data is compatible with the generation of a public database. Due to this, the quality and validity of funded and published studies ought to benefit substantially due to the reduction in the frequency of use of misidentified primary cells.
Kosheeka is bound to deliver high-quality primary cells for maximum customer satisfaction; and hence, depending upon our client’s demands we are providing cells of required passage, specifications, and characterizations. To ensure best-in-class quality, we are characterizing each bath of cell with lineage-specific markers; and third-party certification for the same is being given to the clients.