A revolutionary approach to predict human safety in immunisation programmes involving human stem cells

Dr Subhadra Dravida, Founder CEO, Transcell Biologics explains about NeuroSAFE technology which can be used to predict human safety in immunisation programmes involving human stem cells

In October 2021[1], after a three-decade wait a vaccine for leading killer disease malaria was finally approved. Since traditional safety testing methods such as the monkey-based neurovirulence testing (MNVT) are usually time consuming, such delays are factored into the process. However, since the SARS‐CoV‐2 virus upended the world, even the pharma industry needed to deliver a family of vaccines on a deadline. And despite mandated screenings, some of them are being marked for breaching safety concerns and causing cardiotoxicity, neurovirulence or even Guillain-Barré Syndrome, as was documented after administering certain vaccinations[2].

Neurovirulence & how it’s assessed traditionally

Neurovirulence is the capacity of a virus to cause diseases of the nervous system, and can have major repercussions on infected patients. All vaccines and drugs have to be mandatorily screened for it. The gold standard in vaccine safety assessment today is the MNVT, which requires testing on primates to measure adverse impacts, especially Neurovirulence. This methodology easily requires 8-9 months and demands animal testing; hence is riddled with ethical questions[3]. Also, while primates offer a close approximation to humans, they are not the best substitution. There’re also concerns over its predictive value. Hence, a concerted effort to find more validated alternatives has been going on.

The revolutionary methodology

We have proposed the use of stem cells in an in-vitro environment for vaccine safety assessment to create a revolutionary method of non-animal, human surrogate AI-powered workstation solutions, for predicting human safety. NeuroSAFE is a two-layered solution—first there’s the production and use of stem cells from biological discard such as umbilical cord tissue. Then, there’s the digital platform component that’s embedded with relevant AI and ML tools trained to identify human non-clinical safety data like Neurovirulence. The key differentiator is the use of image-based big data, which includes innumerable options of authenticated neurovirulent responses as benchmark datasets.

When the acquired test material is fed into the system, within a few minutes a response is generated regarding the probability of its Neurovirulence, by comparing it with the system’s big data imprints. If such a result is sought via the traditional method, it would take months and the sacrifice of 100-250 primates.  Thus, the new methodology’s game-changing aspect is not only time efficiency (less than 10 minutes) but also ensuring no animals are harmed. Moreover, the tests can be performed multiple times to ensure efficacy and, yet, at a nominal cost because testing labs are unnecessary to the methodology. There is also the important factor of stem cells mimicking human physiology more closely than MNVT results do, thus guaranteeing near-accurate results every time[4].

Another benefit of this methodology is that it can be used for testing vaccines, adjuvants, small molecules, anti-venom, and cell- and gene-therapy. With this method, a company can go beyond mere screening and testing of vaccines and it can be easily integrated into any existing workflow as a key QC test in vaccine production and for other safety evaluation assays.

Cost savings: Key benefit of the new-age procedure

A grave condition such as Neurovirulence may be caused by the final drug, an intermittent or adjuvant of any kind in vaccines. Hence, all candidates are mandated to be tested at the pre-clinical stage for potential risks. Compound it with the fact that most vaccines need to be assessed periodically. All these factors lead to heavy dependency on testing laboratories, and that means heavy costs accrued regularly. With the adoption of a new-age methodology such as NeuroSAFE, there are several benefits such as affordable, accurate testing that aligns with 3Rs motives in animal testing and seamlessly integrates in user’s workflow. With NeuroSAFE, companies can conduct multiple-level in-house screenings for discovery, development or testing, as and when necessary.

Neurovirulence testing has a huge hidden cost—it not only puts at risk animals needed for testing but also otherwise healthy people who’re afflicted by this condition after ingesting infected material. So, acceptance of revolutionary systems by the government and industry is important to the ultimate adoption of methodologies that help prevent it. The acceptance of breakthrough procedures such as NeuroSAFE can lead to new medical interventions while accelerating innovation and vaccine availability.

References:

[1] https://www.motherjones.com/environment/2022/05/why-took-so-long-malaria-vaccine

[2] https://www.who.int/news/item/26-07-2021-statement-of-the-who-gacvs-covid-19-subcommittee-on-gbs

[3] https://www.sciencedirect.com/science/article/pii/S1877282X11000452

[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310194/