In October 2021, after a three-decade wait, a vaccine for the leading killer disease malaria was finally approved. Traditional safety testing methods such as the monkey-based neurovirulence testing (MNVT) are usually time-consuming. However, after the SARS-CoV-2 virus upended the world, the pharma industry needed to deliver a family of vaccines on a deadline. Despite mandated screenings, some of them are being marked for breaching safety protocols and causing cardiotoxicity, neurovirulence, or even Guillain-Barré Syndrome.
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 necessarily be 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. The use of animal testing is riddled with ethical questions. Also, while primates offer a close approximation to humans, they are not the best substitution. There are also concerns over its predictive value. Hence, there has been a concerted search for more validated alternatives.
NeuroSAFE involves using stem cells in an in-vitro environment for vaccine safety testing — a revolutionary method that is non-animal, human-surrogate, and powered by artificial intelligence (AI). 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 a digital platform embedded with AI and machine learning (ML) tools that are trained to identify human non-clinical safety data like neurovirulence. The key differentiator is the use of image-based big data, which includes a wide range of authenticated neurovirulent responses as benchmark data sets.
When the test material is fed into the system, within minutes there is a response on the probability of neurovirulence, by comparing with the big data imprints. The traditional method, in contrast, would involve months and the sacrifice of 100-250 primates. The new methodology saves time (less than 10 minutes) and is cruelty-free. Moreover, the tests can be repeated multiple times for efficacy, and at a nominal cost, because testing labs are unnecessary for the methodology. There is also the important factor of stem cells mimicking human physiology more closely than MNVT results do, thus ensuring near-accurate results.
Additionally, 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 to integrate it into any existing workflow as a key quality control test in vaccine production and other safety evaluation assays.
A grave condition such as neurovirulence may be caused by the final drug, an intermittent, or an adjuvant of any kind in vaccines. Hence, all candidates are mandated to be tested at the pre-clinical stage for potential risks. Moreover, most vaccines need to be assessed periodically. This leads to heavy dependency on testing laboratories and heavy costs. NeuroSAFE, on the other hand, is affordable, enables accurate testing that aligns with the 3R (reduction, refinement and replacement) principles in animal testing, and seamlessly integrates into the user’s workflow. With NeuroSAFE, companies can conduct multiple-level in-house screenings for discovery, development or testing.
Neurovirulence testing has a huge hidden cost — it not only puts animals at risk but also otherwise healthy people who ingest infected material. Breakthrough procedures such as NeuroSAFE can lead to new medical interventions while accelerating innovation and vaccine availability.
(The writer is CEO, NeuroSAFE)
September 18, 2022