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:
Key learning objectives:
Wenyan Leong, PhD
Cell Processing Specialist, Terumo BCT (Asia Pacific)
Wenyan Leong, Ph.D. is the Cell Processing Specialist for the Cell Therapy Technologies portfolio of Terumo BCT. 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 BCT, 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 BCT 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 BCT.
Watch this On Demand webinar with our expert panel to gain insight into:
Jim Beltzer, PhD
Senior Cell Processing Specialist, Terumo BCT (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 BCT. 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:
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.
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:
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.
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.
This white paper demonstrates how the Quantum system provides a functionally closed, automated and scalable expansion method to generate clinically relevant yields of MSCs from whole bone marrow and precultured cells on the Quantum system utilizing fibronectin or cryoprecipitate as an adhesion promoter.
Specifically, this case study outlines how the efficient use of both human and facility resources maintained a cost savings of 40 percent relative to manual manufacturing methods.
This white paper demonstrates the expansion of T-cells in the Quantum system. Results from a single stimulation event showed that the Quantum system produced 90- to 500-fold expansion of T-cells starting from an apheresis blood collection in as little as 13 days.
Hear how a Denmark hospital uses Quantum to offer patients an innovative cardiac treatment option.
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