The COVID-19 pandemic caused by Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2) increases the need for rapid development of
efficient vaccines. Among other vaccines in clinical trials, a
recombinant VSV-∆G-spike vaccine was developed by the Israel Institute
for Biological, Chemical and Environmental sciences (IIBR) and is being
evaluated. Development of an efficient downstream purification process
(DSP) enables advancing the vaccine to clinical trials. The DSP must
eliminate impurities, either process- or product -related, to yield
sufficient product with high purity, potency, and quality. To acquire
critical information on process restrictions and qualities,
incorporation of on-line monitoring is vital. Application of on-line
monitoring should significantly impact process yield, product quality
and economy of the entire process. Here, we describe an on-line
monitoring technique that was applied in the DSP of the VSV-∆G-spike
vaccine. The technique is based on determining concentrations of
metabolites, nutrients and a host cell protein (HCP) by the automatic
chemistry analyzer Cobas Integra 400 Plus. The analysis revealed
critical information on process parameters and significantly impacted
purification processes. The technique is rapid, easy and efficient.
Adaptation of this technique during the purification process improves
process yield, product quality and enhances the economy of the entire
downstream process of biotechnology and bio pharmaceutical products.
Data fusion based on-line product quality evaluation of ternary cathode material cyber-physical systems