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Informa
08:55 - 09:00 5 mins
Cell Therapy Manufacturing Asia
Chairperson's Opening Remarks
  • Hsiu-ling Hsiao - Chief Scientific Officer, Ever Supreme Bio Technology Co., Ltd., Taiwan
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09:00 - 09:35 35 mins
Cell Therapy Manufacturing Asia
The observation of regulatory requirement and development status of cell therapy
  • Lily Lien - Senior Project Manager, TOT BIOPHARM, China
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  • Regulatory and industrial development status in China
  • Regulatory requirement and industrial development status in Taiwan
  • The challenges and key success factors
09:35 - 10:10 35 mins
Cell Therapy Manufacturing Asia
Conditional and time-limited approval systems for a new regenerative medicinal product in Japan
  • Jason David Sieger - Managing Director, CJ Partners Inc., Japan
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10:10 - 10:30 20 mins
Cell Therapy Manufacturing Asia
Discussion Panel – What can we do to work towards regulatory harmonisation?
  • Lily Lien - Senior Project Manager, TOT BIOPHARM, China
  • Jason David Sieger - Managing Director, CJ Partners Inc., Japan
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  • A look at regulatory strategies in both Asia and the EU/US
  • What can the regions learn from one another
  • What work’s well and what doesn’t?
10:30 - 11:05 35 mins
Morning Coffee and Networking
11:05 - 11:40 35 mins
Cell Therapy Manufacturing Asia
CAR-T therapy induced remission of r/r B-ALL patients pre-treated with HSCT
  • Ting He - CEO, ImmunoChina Pharmaceuticals Co, Ltd., China
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11:40 - 12:15 35 mins
Cell Therapy Manufacturing Asia
Allogeneic T cell therapies – From bench to bedside
  • Daria Paruzina - Product Development Manager (Stem Cells), TC Biopharm, UK
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12:15 - 12:45 30 mins
Cell Therapy Manufacturing Asia
Development of Serum-Free Culture Conditions for CAR T Cell Expansion
  • Hsin-Lin Lu - Research Fellow, Bioengineering Group, Institute of Biologics, Development Centre for Biotechnology, Taiwan
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Expansion of T cells was a critical step for preparing chimeric antigen receptor (CAR) T cells for therapy. Although serum was widely applied in the culture or expansion of T cells, the quality of serum could be varied from batch to batch, leading to the variation of T cell expansion and quality. In addition, the safety of pathogens from serum was required to be considered. To overcome the disadvantages of serum application in T cell culture, serum-free and xeno-free culture conditions were required. Here, we developed a rapid serum-free culture condition for the expansion of immune T cells ex vivo. Human T cells were isolated from the PBMCs of healthy donor using a density gradient medium followed by CD3+ magnetic cell separation. The isolated CD3+ T cells were applied into serum-free medium supplied with IL-2. After a 2-week culture, T cells could expand more than 100-3,000 folds, and the cell viability in all samples was above 90%. The T cell pollutions could be controlled at averagely about 40% of CD8+ T cells and averagely about 55% of CD4+ T cells after culture. These conditions could be applied in the expansion of CAR T cells for cell therapy to support the minimum requirement of blood or cell samples from patients.

12:45 - 14:00 75 mins
Lunch and Networking
14:00 - 14:35 35 mins
Cell Therapy Manufacturing Asia
Implication of small scale adherent or suspension cell virus propagation for large scale viral vector production
  • Rolf Werner - Honorary Senator, University of Tuebingen, Germany
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14:35 - 15:10 35 mins
Cell Therapy Manufacturing Asia
CDMO Expert led panel: How do you choose your development partner?
  • Kim Raineri - Vice President Operations, NIKON CeLL innovation Co., Ltd., Japan
  • Kunihiko Suzuki - Vice Chairman and Member of the Board, MEDINET Co., Ltd., Japan
  • Kazuchika Furuishi - Deputy General Manager, Regenerative Medicine Business Sector, Hitachi Chemical Co., Ltd, Japan
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Informa is looking for 5 speakers to join this panel discussion looking at the below topics:

  • How do you choose your CDMO
  • What capabilities should they have?
  • Centralised manufacturing
  • Regional manufacturing
  • Local manufacturing
  • Considerations for autologous, allogeneic and gene therapy products
  • Tech transfer of processes to new facilities
15:10 - 15:40 30 mins
Cell Therapy Manufacturing Asia
Addressing large-scale viral vector manufacturing using an optimized PEI-based transfection process
  • Guillaume Freund - Scientific Support Specialist, Polyplus-transfection, France
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With the progress in developing new viral vector systems guided by safety, specificity and potency considerations, several gene and cell based therapies are now more than ever closer to being clinically approved and commercially available to treat genetic diseases.

Viral vector delivery systems, of which mainly adeno-associated viruses (AAV) and lentiviruses are produced by transient transfection of mammalian producer HEK-293 cell lines. Virus vector production using the right transient transfection method is crucial to provide the flexibility and reproducibility that is needed to scale-up from initial process development to manufacturing of high-quality grade viral vectors.

Here, we describe an optimized PEI-based virus production process for high-yielding viral vector production with our PEIpro®, compatible with different cell culture adherent and suspension systems. We further demonstrate the robust viral vector production yields, as well as the adaptability and reliability of the PEI-based transient gene expression approach to efficiently manufacture GMP-grade viral vectors at a sufficiently large scale for more advanced clinical trials, and in fine to drive commercialization of therapeutic vectors.

15:40 - 16:10 30 mins
Afternoon Coffee Break
16:10 - 16:45 35 mins
Cell Therapy Manufacturing Asia
Transportation strategies from manufacture to the patient: Elevating bottle necks
  • Hsiu-ling Hsiao - Chief Scientific Officer, Ever Supreme Bio Technology Co., Ltd., Taiwan
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  • logistics of the transfer from manufacture to patient
  • current systems used for transport/cryogenically freezing
  • Preparing samples for use
  • systems used to track shipments
  • what improvements can be made
  • storage and packaging
16:45 - 16:50 5 mins
Cell Therapy Manufacturing Asia
Chairperson's Closing Remarks
16:50 - 16:55 5 mins
End of Conference