Exosome Manufacture Based on the iCELLis® Bioreactor Platform

11th May 2021 | 7:00am BST / 8:00am CEST / 15:00pm JST / 16:00pm AEST | David Haylock, CEO VivaZome Therapuetics and Roberto Ciboldi, Senior Scientist, Purification Team, Scientific & Laboratories Services Pall Corporation |BOOK FREE SEAT FOR THIS WEBINAR

VivaZome Therapeutics is a privately-held Melbourne-based biotech company developing exosome therapeutics. Our approach is to use natural or native exosomes secreted by cells to treat disease. Exosome manufacture involves the separation and concentration of exosomes from cell culture supernatant. VivaZome has identified two human cells types that produce high numbers of angiogenic exosomes suitable for treating a range of ischaemic diseases. The VivaZome preferred cells are adherent and similar to mesenchymal stem/stromal cells in their growth requirements. Accordingly, we evaluated Pall’s iCELLis Nano bioreactor to assess its suitability for supporting exosome manufacture.

Experiments were conducted to assess cell growth for up to 12 days and samples were collected to quantitate and characterize exosomes within cell culture supernatant samples collected at various times during culture. The iCELLis Nano system was easy to operate and the cells grew well. Analysis of cell culture supernatant samples confirmed that exosome production was equivalent or better than that achieved in cells grown in tissue culture flasks. The iCELLis Nano bioreactor platform proved to be a flexible and efficient technology for the culture of our adherent cells and suitable for generating substrate for exosome manufacture.

Presented by David Haylock, CEO VivaZome Therapeutics

David has over 40 years of experience in the bio therapeutics and regenerative medicines industry, principally in the R&D environment. David has experienced in the GMP manufacture of cellular based therapeutics and was Head of Experimental Cell Therapy at the Peter MacCallum Cancer Centre from 1999 until 2005. He was Director of the Major National Research Facility of the Australian Stem Cell Centre from 2005 till 2009 then was appointed as a Science Leader at the Commonwealth Scientific Industrial Research Organisation (CSIRO). David has collaborated with and consulted with multiple major biotechnology companies including Dynal, Johnson and Johnson, Cynata Therapeutics, Baxter Healthcare, Amgen, and Sandoz. David is currently Chief Executive Officer of VivaZome Therapeutics, a Melbourne-based company developing exosome therapeutics. Prior to this role, David was Adjunct Professor, Australian Regenerative Medicine Institute, Monash University and Group Leader, Cell Biology, Biomedical Materials, CSIRO, Australia.

Followed by Overcome Exosomes Production Challenges.

Exosomes are extracellular vesicles (EVs) secreted by most eukaryotic cells. EVs play a key role in the regulation of intercellular communication processes. Over the last couple of years, EVs have been increasingly adopted for tissue engineering and for cell and gene therapy applications. Exosome-based therapies have been hailed as the “next frontier” in cell therapy and regenerative medicine, although they are not expected to replace entirely the current cell therapy treatments. According to Clinicaltrials.gov, in October 2020 there were more than 191 clinical trials worldwide utilizing exosomes.

In this presentation, an innovative and scalable manufacturing platform will be introduced to streamline EV production. The cGMP end-to-end platform consists of robust and reliable technologies, ranging from cell culture to sterilizing filtration and purification.

Combined technologies intensify the EV process starting with the iCELLis fixed-bed bioreactor which improves the isolated EVs population. This is followed by Omega™ tangential flow filtration cassettes providing robust scalability and delivering high purity and cost-effectiveness and finally, Supor® EKV sterilizing filters for efficient EV transmission and consistent size distribution.

Early adoption of scalable cGMP technologies will streamline EV production, avoiding bottlenecks, and facilitating scientists’ decisions on complex process steps.

Presented by Roberto Ciboldi, Senior Scientist, Purification Team, Scientific & Laboratories Services Pall Corporation

Roberto is a senior scientist, part of the Purification Team at Pall Corporation. Originally from Milan, Roberto joined Pall in 2013, he studied Chemistry at P.  Carcano University and is currently studying Economy at Insubria University.  He works on developing new processes or supporting existing ones specifically on chromatography, depth filtration, and tangential flow filtration, and previously was involved in the Pall Validation Laboratories for two years.   Roberto previously supported the Quality Assurance of a pharmaceutical company for two years during college study.

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