2021 ISEV Workshop: massivEVs

An ISEV workshop on massive production of EVs, coorganized with the H2020-FETOpen projects evFOUNDRY http://www.evfoundry.eu and VES4US https://ves4us.eu

When: 28th-29th October 2021

Where: Brescia, Italy

Venue: Hotel Acquaviva del Garda: Viale Francesco Agello, 84, 25015 Desenzano del Garda (Brescia), Italy

International Organizing Committee (IOC)

Co-Chairs:

  • Paolo Bergese

  • Antonella Bongiovanni

  • Marca Wauben

  • Nicolas Touzet

  • Peter Nejsum

  • Annalisa Radeghieri

  • Lucia Paolini

  • Kenneth Witwer

  • Eva Rohde

Description

The goal of the workshop was to address and channel the efforts towards large scale EV production and manufacturing. Themes ranging from the underpinning science and technology of equipment and processes to good manufacturing practices (GMPs) and requirements were featured.

The workshop featured a dialogue between an outstanding and diverse group of academic research scientists, clinicians and industrial partners involved in massive production of EVs.

Introductory invited talks, short talks selected from abstracts, posters and roundtable discussions revolved around four highly interrelated themes related to large-scale EV production:

1) Massive production from Human sources and applications (including therapeutics, nutraceutics, cosmetics, EV based nanotechnology)

2) Massive production from other (than human) sources and applications

3) Upstream and downstream technologies and process upscaling

4) Validation, standardization and regulatory issues.

The workshop was expected to lead to one or more products, such as an ISEV position paper, perspectives papers on massive EV production, etc.

50 participants were selected on the basis of their expertise.

 

Program (CEST time)

27th October 2021

18:00-19:00 Registration

19:00 Welcome reception

28th October 2021

8:00-8:30 Registration

8:30-8:40 Welcome (Paolo Bergese, Antonella Bongiovanni)

8:40-8:50 Overview of ISEV-MassivEVs workshop and products (Kenneth Witwer)

8:50-9:20 Opening talk - Marca Wauben, Department of Biochemistry and Cell Biology, Faculty of Veterinary Medicine, Utrecht University, Utrecht, Netherlands. “Towards a robust characterization of EV-enriched massive preparations”

9:20-11:10 Topic 1 - Massive production from Human sources and applications (including therapeutics, nutraceutics, cosmetics, EV based nanotechnology)

Chairs: Annalisa Radeghieri and Marca Wauben

Plenary sessions

  • Mario Gimona, Paracelsus Medical University, Salzburg, Austria. "Scalable manufacturing and quality control of naive human umbilical cord MSC-sEVs for clinical testing: Sufficient for the day is the evil thereof"

  • Eva Rohde, University Hospital Salzburger Landeskliniken GesmbH and Paracelsus Medical University, Salzburg, Austria. “Bridging the Translational Gap in Clinical EV-Tx Development”

Oral presentations

  • Saara Laitinen, Finnish Red Cross Blood Service (Finland). “Blood cells as endless source of blood compatible EVs”

  • Amanda Silva, CNRS / Paris University (France), “Boosting high-yield scalable production of extracellular vesicles from adipose stromal cells by turbulence in bioreactors for regenerative medicine”

  • Steven Jay, University of Maryland (USA). “3D Printed Perfusion Bioreactors for Scalable Production of Therapeutic Extracellular Vesicles”

  • Simonides Immanuel van de Wakker, UMC Utrecht (Nederland). “Upscaling of sEV production using multilayer cell factories combined with an optimized isolation protocol allows for higher recovery rates with conservation of sEV function”

11:10-11:30 Networking coffee break

11:30-13:10 Topic 3 - Upstream and downstream technologies and process upscaling

Chairs: Antonella Bongiovanni and Paolo Bergese

Plenary sessions

  • Konstantin Konstantinov, Codiak, Cambridge, MA, USA. “Industrialization of the GMP Manufacture of Exosome Therapeutics and Opportunities for Further Multifold Process Productivity Increase”

  • Michiel Stork, Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands. “Production of Outer Membrane Vesicles for vaccine purposes”

Oral presentations

  • Fabio Antenucci, University of Copenhagen (Denmark). “Development and testing of a centrifuge-free one-step protocol for the clarification of bacterial supernatants”

  • Marta Costa, iBET, Instituto de Biologia Experimental e Tecnológica (Portugal), “Scalable and chemically-defined manufacturing of mesenchymal stromal cells-derived extracellular vesicles with augmented cardiac regenerative properties”

  • Xiaoqin Wang, AstraZeneca (Sweden), “Anion exchange chromatography for scalable isolation of extracellular vesicles”

13:10-14:10 Networking lunch break

14:10-15:30 Parallel round table discussions (participants divided in 2 groups)

  • Round table on Topic 1 - First session (group 1), Moderators: chairs (Annalisa Radeghieri and Marca Wauben) and experts (Mario Gimona and Eva Rohde)

  • Round table on Topic 3 - First session (group 2), Moderators: chairs (Antonella Bongiovanni and Paolo Bergese) and experts (Konstantin Konstantinov and Michiel Stork)

15:30-16:00: Networking coffee break with posters (Poster Chair: Lucia Paolini)

16:00-17:20: Parallel round table discussions (2 groups divided over 2 topics)

  • Round table on Topic 1 - Second session (group 2) Moderators: chairs (Annalisa Radeghieri and Marca Wauben) and experts (Mario Gimona and Eva Rohde)

  • Round table on Topic 3 - Second session (group 1) Moderators: chairs (Antonella Bongiovanni and Paolo Bergese) and experts (Konstantin Konstantinov and Michiel Stork)

17:20-18:00 Networking coffee break with posters (Poster Chair: Lucia Paolini)

18:00-19:30 Wrap up round table Topic 1 and 3 + decision on possible workshop product(s)

19:30-20:00 Networking reception with posters (Poster Chair: Lucia Paolini)

20:30 – Dinner on site

29th October 2021

9:00-10:40 Topic 2 - Massive production from other (than human) sources and applications

Chairs: Nicolas Touzet and Peter Nejsum

Plenary sessions

  • Maria Kaparakis-Liaskos (La Trobe University, Melbourne, Australia) “Large scale production and purification of bacterial membrane vesicles”

  • Nicole Meisner-Kober (University of Salzburg, Salzburg, Austria) “Process development and industrial scale isolation of food-derived EVs”

Oral presentations

  • Mauro Manno, National Research Council of Italy (CNR) (Italy). “Extracellular vesicles from microalgae: a renewable and scalable bioprocess”

  • Antonio Marcilla, Universitat de València (Spain), “Exploring the massive production of EVs in plants for biomedical applications”

  • Dionysios C. Watson, University Hospitals; Case Western Reserve University; Cleveland Clinic (USA), “Scalable ultracentrifuge-free isolation of bacterial EVs: opportunities and challenges”

10:40-11:00: Networking coffee break

11:00- 12:40 Topic 4 - Validation, standardization and regulatory issues

Chairs: Eva Rohde and Kenneth Witwer

Plenary sessions

  • Lang Tran (Institute of Occupational Medicine, Edinburgh, UK). “Biomaterials – Safe and Smart materials for Advanced Therapy. A Case Study – Treatment for Alzheimer’s Disease”

  • Sai Kiang Lim (Institute of Molecular and Cell Biology; Agency for Science, Technology and Research, Singapore). “Towards regulatory compliance for identity and potency of MSC-sEVs”

Oral presentations

  • Marta Monguió-Tortajada, Germans Trias i Pujol Research Institute (Spain), “Standardization of MSC-EV production for clinical purposes: a preliminary experience”

  • Natasa Zarovni, HansaBiomed Life Sciences and Exosomics (Estonia), “The novel prospects for delivering an end-to-end roadmap for bioactive EVs in therapy and custom care”

  • Mario Barilani, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico (Italy), “Human induced pluripotent stem cells as inexhaustible source of therapeutic extracellular vesicles”

12:40-13:40 Networking lunch break

13:40-14:20 Parallel round table discussions (participants divided in 2 groups)

  • Round table on Topic 2 - First session (group 1), Moderators: chairs (Nicolas Touzet and Peter Nejsum) and experts (Maria Kaparakis-Liaskos and Nicole Meisner-Kober)

  • Round table on Topic 4 - First session (group 2), Moderators: chairs (Eva Rohde and Kenneth Witwer) and experts (Sai Kiang Lim and Lang Tran)

14:20-14:50: Networking coffee break with posters (Poster Chair: Lucia Paolini)

14:50-16:30 Parallel round table discussions (2 groups divided over 2 topics)

  • Round table on Topic 2 - Second session (group 2), Moderators: chairs (Nicolas Touzet and Peter Nejsum) and experts (Maria Kaparakis-Liaskos and Nicole Meisner-Kober)

  • Round table on Topic 4 - Second session (group 1), Moderators: chairs (Eva Rohde and Kenneth Witwer) and experts (Sai Kiang Lim and Lang Tran)

16:30-17:30 Networking coffee break with posters (Poster Chair: Lucia Paolini)

17:30-19:00 Wrap up round table Topic 2 and 4 + decision on possible workshop product(s)

19:00 Closing drink

20:30 Dinner in Desenzano del Garda (optional)


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