In this webinar, learn more about the ongoing research and clinical trials to manage acute respiratory distress syndrome (ARDS) in COVID-19 patients. Two experts will share their extensive experience with therapies using mesenchymal stem cells (MSCs) and the small extracellular vesicles (sEVs) that MSCs produce as potential treatments for COVID-19 patients with ARDS.

What will you learn?

Explore how sEVs can recapitulate the therapeutic effect of MSCs Discuss clinical trial design with critically ill patients, such as those with COVID-19, including strategies for optimizing sample size, managing patient and disease heterogeneity, and maximizing the use of trial data.

Learn how the lung inflammatory environment may alter MSC behavior

About the presenters:

Michael Matthay, MD
Professor of Medicine School of Medicine, University of California San Francisco (UCSF; CA, USA)

Dr Matthay did his undergraduate studies at Harvard (MA, USA) and received his medical training at the School of Medicine University of Pennsylvania (PA, USA). He was an intern and resident in Internal Medicine at the University of Colorado Medical Center (CO, USA) and performed fellowships at the Pulmonary Division and the Cardiovascular Research Institute at UCSF. He is currently a Professor of Medicine and Anesthesia at the School of Medicine, UCSF. He has received many awards including the Edward Livingston Trudeau Medal, of the American Thoracic Society and a Lifetime Achievement in Mentoring Award from UCSF.

Dr Matthay has studied the pathogenesis and resolution of ARDS, with an emphasis on translational work and patient-based research, including clinical trials. His more recent research has focused on the biology and potential clinical use of allogeneic bone marrow-derived MSCs for ARDS. Dr Matthay will discuss the ongoing challenge of treating patients with severe ARDS from COVID-19. He will discuss the management of COVID-19 ARDS in the current era and the possible new treatments including MSCs that are being tested in his Phase IIB efficacy trial now supported by National Institutes of Health (MD, USA) and the Department of Defense (VA, USA).

Ben Buller, PhD
Associate Scientist Department of Neurology at Henry Ford Health System
Adjunct Associate Professor Oakland University, Scientific Consultant at NeurExo Sciences (all MI, USA)

Dr Buller is an Associate Scientist in the Department of Neurology at Henry Ford Health System in Detroit and he serves as an Adjunct Associate Professor at Oakland University and as a consultant at NeurExo Sciences, developing therapeutics using exosomes. He also served as Chief Scientific Officer at Forever Labs (MI, USA). Dr Buller has been pivotal in demonstrating the role of exosomes in the delivery of microRNAs to treat stroke and traumatic brain injury. In this webinar, he will discuss his investigation into the use of MSC exosomes to treat ARDS in COVID-19 patients.

In the ever-changing landscape of cell therapy development, there is great interest in seeing how others in the industry are automating their processes in an effort to serve more patients. Join us for this informative webinar where two experienced speakers will share how Cell2Cure, a clinical-stage biotherapeutics company, is using automated cell expansion to speed production of “off-the-shelf” cellular therapies.

• Learn how they established a robust cell manufacturing platform for large-scale production
• See how they addressed manual process challenges
• Understand the challenges of cell therapy manufacturing and how they met their goal to standardize and automate
• Review the benefits of bioreactors over a flask-based system to expand clinically applicable mesenchymal stromal cells on a large scale

About the presenters:

Jens Kastrup, MD, DMSc
Chief Physician, Department of Cardiology, The Heart Centre, Rigshospitalet, Denmark

Dr. Jens Kastrup is clinical professor in cardiovascular/translational medicine – regenerative gene and stem cell therapy within Cardiology at Rigshospitalet University of Copenhagen, Denmark.

As a clinical cardiologist, he established the Cardiology Stem Cell Centre, which is approved by the Danish Medicines and Health Agency for production of stem cells for clinical trials. During the last 17 years, he has conducted several clinical trials with gene and stem cell therapy in patients with both acute and chronic ischemic heart disease.

Mandana Haack-Sørensen, MSc, PhD
Director of Manufacturing, Cell2Cure

Dr. Mandana Haack-Sørensen obtained her Master of Science Biomedicine from Syddansk University, Odense and conducted her PhD studies in translational medicine at the Cardiology Stem Cell Centre, University Hospital Rigshospitalet, Copenhagen.

For more than 18 years, she has led the innovation and implementation of in vitro lab science using different cell types that could be translated to clinical settings, including isolation from different tissue sources, establishment of different culture expansion platforms, and manual and automated cultivation.

There is a clear call to automate manufacturing for cell and gene therapy products, but when should you automate? In this session, we will consider the shifting priorities as you move from product development towards clinical manufacturing and discuss how choosing the right type of automation can create immediate impact without compromising flexibility. Case studies in adherent and suspension cell expansion, gene modification and cell secretome production will be presented.

Who may be interested:

• Clinicians, researchers, lab technologists and cell therapy industry professional
• Cell and gene therapy manufacturing professionals
• Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs)

Key learning objectives:

• Understand the impact of Investigational New Drug submission on the manufacturing process
• Learn how various adopters of the Quantum® Cell Expansion System have improved their manufacturing processes

About The Presenter:

Wenyan Leong, PhD

Cell Processing Specialist, Terumo Blood and Cell Technologies (Asia Pacific)

Wenyan Leong, Ph.D. is the Cell Processing Specialist for the Cell Therapy Technologies portfolio of Terumo Blood and Cell Technologies. Responsible for managing knowledge transfer and implementation of efficient and safe manufacturing solutions in the cell & gene therapy field, Dr. Leong works closely with various industry representatives, researchers and clinicians throughout Asia Pacific.

Prior to joining Terumo Blood and Cell Technologies, she spent 4 productive years in academic research on cell-laden tissue engineering platforms, working with a variety of cell types and biomaterials. Her contribution of 10 research articles and 3 patents to this specialty resulted in a Ph.D. (Bioengineering) conferment from Nanyang Technological University, Singapore.

In this webinar Terumo Blood and Cell Technologies present two perspectives on automation in the cell therapy space featuring well known experts in the field: Dr. Bruce Levine, who discusses recent developments in CAR T cell processes and Gerhard Bauer, who discusses Viral Vector production and other recent advances in his laboratory. This thoughtful discussion will be moderated by Dr. Jim Beltzer from Terumo Blood and Cell Technologies.

Watch this On Demand webinar with our expert panel to gain insight into:

• Specific real-world experiences of implementing automation strategies, tools, and technologies at different stages in the product development life-cycle for cell and gene therapies;
• Key considerations in the implementation of automation: Resources, Processes Determining Factors, Challenges, Device Selection, Outlook on Future;
• Important manufacturing considerations to enable large-scale, quality-assured vectors for clinical use;
• Moving the conversation forward in addressing the cost-effective, scalable manufacture of CAR-T therapies, and their safety and clinical outcomes;
• An exploration into what works now, why, and what directions they would like to see the field take in the future, from our two experts in cell processing.

About The Presenter:

Jim Beltzer, PhD

Senior Cell Processing Specialist, Terumo Blood and Cell Technologies (Colorado, U.S.)

Jim earned his PhD in biochemistry at Purdue University and completed his post-doctoral fellowship at the Biocenter in Basel, Switzerland. He worked at several start-up biotechnology companies in the Boston area and at Corning Life Sciences prior to joining the cell processing team at Terumo Blood and Cell Technologies. He has more than 25 years of research and development experience in a broad range of disciplines.

Looking for potential solutions to your cell therapy manufacturing challenges?

This presentation identifies the challenges associated with early-stage cell therapy manufacturing and reviews potential solutions focusing on recent advances in cellular therapy—from mesenchymal stromal cells (MSCs) to tumor-specific T cells.

More specifically, Dr. Hanley will discuss:

• Manufacturing cells in an academic good manufacturing practice (GMP) facility
• Meeting the demands of investigators
• Overcoming challenges to expand these therapies

About The Presenter:

Patrick J. Hanley, PhD

Director, GMP for Immunotherapy, Children's National, and Assistant Professor, George Washington University (Washington, DC, USA)

Dr. Hanley is the director of the class 10,000 GMP facility at Children's National Health System, which is charged with manufacturing novel cellular therapies for the Program for Cell Enhancement and Technologies for Immunotherapy (CETI) under investigational new drug (IND) applications, as well as processing standard-of-care stem cell transplant products. He is also responsible for all follow-up and immune reconstitution testing performed on patients treated on CETI's protocols. Trained as an immunologist, Dr. Hanley has an extensive background and interest in cellular therapy.

This webinar evaluates different options for scaling up large quantities of bone-marrow-derived MSCs (BM-MSCs), using methods that can be performed in compliance with good manufacturing practices (GMP).Topics covered include cell yields, cost, time, effort and ease of use with either automated or manual methods to manufacture enough BM-MSCs to administer a single dose of 100 × 10⁶ cells per patient.

In this webinar, you will learn about cost-benefit analysis for manual versus automated MSC manufacturing for phase I and II clinical trials.

About The Presenter:

Athena Russell, MT(AAB)

Lead Medical Laboratory Scientist and Assistant Professor, Mayo Clinic (Jacksonville, FL, USA)

Athena Russell is Lead Medical Laboratory Scientist of the Human Cellular Therapy Laboratory and Assistant Professor of Laboratory Medicine and Pathology at Mayo Clinic in Jacksonville, Florida. She has held multiple positions at Mayo Clinic, concentrating her work on mesenchymal and hematopoietic stem cell research, as well as other cellular and cell-derived therapies. Dr. Russell also holds elected positions with the International Society for Cellular Therapy and the American Association of Bioanalysts.

Gain insights into T-cell expansion, viral vector production and scaling production of mesenchymal stem cells (MSCs) through the use of a functionally closed, automated cell culture process.

Dr. Beltzer presents several case studies describing how process development and economic goals were achieved in industry and academic settings. Results include a 500-fold expansion of T-cells in 12 days, 40 percent reduction in cost of goods (COGs) of growing cells for an allogeneic cell therapy and automated viral vector production with titers similar to flask-based processes. Particular attention will be directed toward the process changes often needed to meet these goals.

In this webinar, you will:

• See the results of T-cell expansion using a hollow-fiber bioreactor system
• Learn techniques for scaling production of MSCs
• Discover a new approach to viral vector production
• Hear about a case study on achieved cost and labor savings

About The Presenter:

Jim Beltzer, PhD

Senior Cell Processing Specialist, Terumo Blood and Cell Technologies (Colorado, U.S.)

Jim earned his PhD in biochemistry at Purdue University and completed his post-doctoral fellowship at the Biocenter in Basel, Switzerland. He worked at several start-up biotechnology companies in the Boston area and at Corning Life Sciences prior to joining the cell processing team at Terumo Blood and Cell Technologies. He has more than 25 years of research and development experience in a broad range of disciplines.

To transform the promise of cell-based therapies into reality, a robust and scalable process is required to be compliant with current good manufacturing practice (cGMP) regulations. From clinical to commercial manufacturing, processes need to produce progressively larger batches with consistent product quality.

Developing these processes may allow affordable and sustainable therapies to reach the market more quickly. Here we present a case study from the large-scale expansion of a process using human stem cells obtained from adult bone marrow.

In this webinar, you will:

• Hear about a process used to scale out an allogeneic cell therapy
• Learn the advantages of using bioreactors for cell therapy manufacturing

About The Presenter:

Amel Tounsi, PhD

Development and Project Manager, MaSTherCell (Gosselies, Belgium)

After receiving a master’s degree at the Université Louis-Pasteur in France, Amel Tounsi obtained her PhD in immunology and cellular biology at UCL (Université catholique de Louvain) in Brussels. She then completed a postdoctoral fellowship at a German cancer research center where she worked on the establishment of in vivo models in mice to study the immune-regulatory activity of bone-marrow-derived mesenchymal stem cells. After her academic experience, she joined the research and development (R&D) department of Cardio3 Biosciences (now called Celyad), a Belgian biotech company developing a stem cell therapy for the treatment of chronic heart failure. Amel was involved in process improvement and developed release and potency assays. Her expertise in academia, R&D and the biotech industry was an asset for MaSTherCell, where she has worked as development and project manager since August 2014.