Global Stakeholder Initiatives

MANUFACTURING WITH COMMERCIALIZATION IN MIND

Concurrent Speaker(s)

• 

  Ricardo Baptista, Eng PhD (he/him/his)

  SmartCella, Sweden
• 

  Ana Hidalgo-Simon, MD, PhD (she/her/hers)

  Internal Medicine
  Leiden University Medical Center, Netherlands
• 

  Lijian Hui, PhD

  Shanghai Institute of Biochemistry and Cell Biology
  Center for Excellence in Molecular Cell Science, CAS, China
• 

  Stefan Irion, MD (he/him/his)

  Research
  BlueRock Therapeutics, United States
• 

  Tenneille Ludwig, PhD (she/her/hers)

  WiCell Stem Cell Bank
  WiCell Research Institute, United States

This session will explore key considerations in developing stem cell-derived therapies for commercial use, focusing on critical factors such as starting material selection, genetic integrity, manufacturing scale, bioprocess complexity, and the assessment of final product comparability and analytical assays.

Presentations:

• CELL IDENTITY CONVERSION: LIVER REGENERATION AND CELL THERAPY
  

  Concurrent Speaker: Lijian Hui, PhD – Center for Excellence in Molecular Cell Science, CAS
• INCREASING TRANSLATION BY INBUILT REGULATORY CONSIDERATIONS
  

  Concurrent Speaker: Ana Hidalgo-Simon, MD, PhD (she/her/hers) – Leiden University Medical Center
• MANUFACTURING OF STEM CELL THERAPIES WITH COMMERCIALISATION IN MIND
  

  Concurrent Speaker: Ricardo Baptista, Eng PhD (he/him/his) – SmartCella
• QC AND CQAs: QUALITY ASSESSMENT FOR PSC CELL BANKS TODAY AND A VISION FOR THE FUTURE
  

  Concurrent Speaker: Tenneille Ludwig, PhD (she/her/hers) – WiCell Research Institute
• SCALING MOUNT COMMERCIAL: NAVIGATING THE PEAKS OF MANUFACTURING COMPARABILITY
  

  Concurrent Speaker: Stefan Irion, MD (he/him/his) – BlueRock Therapeutics