Workstation Solutions To Become A New Norm In Testing Safety & Efficacy Of Vaccines

The following adaptable solution is designed to integrate into Industry’s any existing workflow disrupting the concept of outsourcing to testing labs.

COLORADO SPRINGS, UNITED STATES, USA, June 23, 2021 /EINPresswire.com/ -- Various state and regional agencies have adopted the 3Rs policy of replace, reduce, and refine, and have proceeded to more intelligent ways of testing strategies. For instance, an integrated strategy for safety testing built around a systems biology framework has been proposed, and aspects of these implemented in the US FDA and EU programs for checking Cardiotoxicity; The genetic, transcriptomic, and proteomic phenotypic “readouts” or measurable endpoints acquired from the human in vitro surrogate systems can be used together with AI embedded platforms in predicting adverse events or safety-related signatures of the candidate being tested. Ethical issues will influence the sourcing and use of stem cells in the various in vitro models; for instance, should the raw material be sourced ethically from biological discards from patients, or should they be sourced from the more ethically controversial biopsies? While the digital platforms powered with AI will have the ability to address throughput and patterns complementing the Solution provided to the Industry.

Monkey Neurovirulence Test (MNVT) is one such age-old WHO protocol that every Vaccine producer should embrace as part of their R&D till production for immunization programs. In most of the instances, there is proven value in the neurovirulence test (NVT) in the life cycle of a vaccine, for example: for polio vaccine for which the test is part of routine batch release procedures; for yellow fever vaccine NVT has been designed to allow quantitative assessment of the effects of the virus by examination of specific areas following directed inoculation; for Covid-19 NVT is a mandatory quality control test as the causative human coronavirus is clinically established to be causing Neurological debilitation in patients.

All though, advances in the application of alternative tests for NVT have been researched, the objective criteria in those tests developed have been vague. The recently announced partnership between Transcell Oncologics and Wipro applying advanced artificial intelligence to medical science-based data to deliver state-of-the-art solutions is on the delivery of Workstation solutions to the Industry. One of the first in pipeline solutions from this partnership to reach the markets helps enable the testing of vaccines on human stem cells for the required insights on safety (Neurovirulent Phenotype, Cellular infiltrations, Microbiological contamination
and potency, thereby eliminating the need to test on primates while detecting the Neurovirulence signals in pharmacovigilance programs.

The adaptable solution is designed to integrate into Industry’s any existing workflow disrupting the concept of outsourcing to testing labs.


A Workstation Solution Prototype
References:
Transcell Oncologics developed www.transtoxbio.com
https://www.wipro.com/newsroom/press-releases/2021/wipro-partners-with-transcell-oncologics-to-transform-vaccine-safety-assessment/

Dr.Subhadra Dravida
Transcell Oncologics LLC
+91 8297256755
suba.dravida@tran-scell.com
Visit us on social media:
Facebook
Twitter
LinkedIn