In-Line Monitoring of Downstream Purification Processes for VSV Based SARS-CoV-2 Vaccine Using a Novel Technique

The COVID-19 pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) increases the need for a 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 Research (IIBR) and is being evaluated. The development of an efficient downstream purification process (DSP) enables the vaccine to be advanced to clinical trials. The DSP must eliminate impurities, either process- or product-related, to yield a sufficient product with high purity, potency and quality. To acquire critical information on process restrictions and qualities, the application of in-line monitoring is vital and should significantly impact the process yield, product quality and economy of the entire process. Here, we describe an in-line monitoring technique that was applied in the DSP of the VSV-∆G-spike vaccine. The technique is based on determining the concentrations of metabolites, nutrients and a host cell protein using 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. Adopting this technique during the purification process improves the process yield and the product quality and enhances the economy of the entire downstream process for biotechnology and bio pharmaceutical products.

Highly Efficient Purification of Recombinant VSV-∆G-Spike Vaccine against SARS-CoV-2 by Flow-through Chromatography

This study reports a highly efficient, rapid one-step purification process for the production of the recombinant vesicular stomatitis virus-based vaccine, rVSV-∆G-spike (rVSV-S), recently developed by the Israel Institute for Biological Research (IIBR) for the prevention of COVID-19. Several purification strategies are evaluated using a variety of chromatography methods, including membrane adsorbers and packed-bed ion-exchange chromatography. Cell harvest is initially treated with endonuclease, clarified, and further concentrated by ultrafiltration before chromatography purification. The use of anion-exchange chromatography in all forms results in strong binding of the virus to the media, necessitating a high salt concentration for elution. The large virus and spike protein binds very strongly to the high surface area of the membrane adsorbents, resulting in poor virus recovery (<15%), while the use of packed-bed chromatography, where the surface area is smaller, achieves better recovery (up to 33%). Finally, a highly efficient chromatography purification process with CaptoTM Core 700 resin, which does not require binding and the elution of the virus, is described. rVSV-S cannot enter the inner pores of the resin and is collected in the flow-through eluent. Purification of the rVSV-S virus with CaptoTM Core 700 resulted in viral infectivity above 85% for this step, with the efficient removal of host cell proteins, consistent with regulatory requirements. Similar results were obtained without an initial ultrafiltration step.

On-line monitoring of downstream purification processes for VSV based SARS-CoV-2 vaccine by a novel technique

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.

International teleconferences in EGAP courses: preparing students for prospective professional situations

This paper describes a joint programme developed in 2018 by the University of Parma Language Centre (Italy) and the Humanities and Arts Department of the Technion-Israel Institute of Technology. The aim of the project was to involve students of English for General Academic Purposes in delivering presentations to an unfamiliar foreign audience on a topic relevant to their academic interests. The students were required to prepare for the presentation by exploring and personalising the chosen topic so as to be able to explain it to a group which they had had no previous contact with or information about. Through the active involvement of the students in a realistic implementation of their prospective professional use of English, language learning became a holistic experience where a traditional approach to language learning focusing mainly on vocabulary and macro-skills was integrated with a pragmatic approach which addressed the so-called ‘21st-century skills’ (specifically critical thinking, communication, collaboration and digital literacy). The simulation of situations that they are likely to encounter in their professional lives helped students build their confidence, with the whole learning experience carrying both emotional and social implications. This paper offers an insight into the challenges and issues which arose, and ideas for improving the learning experience. We describe the preparation carried out by the teachers at both universities, and the guided and autonomous work carried out by students in the different stages. A post-conference survey triggered the students’ self-reflection in relation to learning and personal development. The survey was also valuable for the teachers regarding reassessment of teaching strategies and preparation for future joint projects.

Human Ability to Learn According to the Feldenkrais Method: From Writings to Practice

The Feldenkrais method seeks to improve individual ability, and human functioning in general, through movement. According to Moshé Feldenkrais, refining movement by enhancing the nervous system’s functioning also improves our ability to learn. The method has already been shown to improve mood, quality of life, and various physical aspects. The present study seeks to examined students’ theoretical learning capabilities during a Feldenkrais lesson, during a period of a few hours after the lesson, and the correlation between these two time periods.The main research question was: Does doing Feldenkrais exercises improve the ability to learn in 120 students at Technion-Israel Institute of Technology. The findings show that the students assimilated the theoretical content conveyed during the lessons. The study also found that most of the students experienced improved ability for theoretical learning after the lessons. A strong, positive correlation was found between the students’ high ability for theoretical learning during the lesson, and improvement in the learning ability of the same students, experienced after the lesson. The study’s conclusion is that a variety of internal, physiological and mental/emotional processes occur when doing Feldenkrais exercises, which alleviate pain, create new neural pathways between the brain and the body, and also “unblock” stressful neural pathways, and which significantly improved the participants’ concentration, attention, and theoretical learning abilities, both during and after the lessons.