June 2022 

Presentation: ‘Current Issues in the Manufacture of hPSC-based Medicines’

Discussion Topics:

• Effective Analytics for Allogeneic Cell Therapies 

• Progression through clinical trials 

• Development of relevant bioassays for potency, comparability and to identify critical quality attributes (CQAs)

Discussion Leader:

• Glyn Stacey, Gene and Cell Therapy Committee, International Stem Cell Banking Initiative and PIFI Fellowship, Institute of Zoology Chinese Academy of Sciences 

June 2022

Discussion Topics:

• Manufacturing challenges for gene therapy products: product quality and productivity
• Strategies for commercialisation of CGT therapies: Expansion to global markets  
• Standardisation of regulatory guidelines: improving alignment  

Discussion Panel:

• Glyn Stacey, Gene and Cell Therapy Committee, International Stem Cell Banking Initiative and PIFI Fellowship, Institute of Zoology Chinese Academy of Sciences 
• Ajan Reginald, Chief Executive Officer, Celixir 
• Michael Fossel, President and Founder, Telocyte 

May 2022

Discussion Topics:

Presentation: “Industry Overview and Market Trends- Upstream Bioprocessing” by Amir Reza Goudarzi, Senior Director of Bioprocess Technologies at Bayer 

Presentation: “Case Study” by Matthew Coleman, Senior Engineer of Process Engineering Cell Culture, Genentech 

• Analysing the resemblance between cell-therapy and biologics 
• Facilitating technology transfer for cell-based products
• Establishing effective and efficient partnerships
• Case studies on effective technology and knowledge transfer: successes and pitfalls

Discussion Leaders:

• Amir Reza Goudarzi, Senior Director of Bioprocess Technologies at Bayer
• Glyn Stacey, Gene and Cell Therapy Committee, International Stem Cell Banking Initiative and PIFI Fellowship, Institute of Zoology Chinese Academy of Sciences
• Williams Olughu, Principal Scientist and BPA Lead, Ipsen 
• Matthew Coleman, Senior Engineer of Process Engineering Cell Culture, Genentech

April 2022

Discussion Topics:

• Presentation: “Landscape Overview”, by Raymond R Mattingly, Professor & Chair, Pharmacology & Toxicology, Brody School of Medicine, East Carolina University
• Accelerating the integration of 3D models within research 
• Identification of barriers 
• Looking towards the future of 3D technology applications 
  
  

Discussion Panel:

• Raymond R Mattingly, Professor & Chair, Pharmacology & Toxicology, Brody School of Medicine, East Carolina University 
• Sasha Mendjan, Human Mesodermal Organogenesis Group, Institute of Molecular Biotechnology
• Darius Widera, Associate Professor in Stem Cell Biology and Regenerative Medicine, University of Reading

March 2022

Discussion Topics:

• Presentation: “Development and characterisation of tissue-specific cell lines for investigation of inflammatory pathways” by Darius Widera, Associate Professor in Stem Cell Biology and Regenerative Medicine, University of Reading 
• Increasing Clone Selection Efficiency In Cell Line Development 
• Optimisation of clone generation to ensure more predictable and effective cell line development 
• Key factors including gene editing technologies, single cell cloning methods, growth media and supplements
   

Discussion Leaders:

• Darius Widera, Associate Professor in Stem Cell Biology and Regenerative Medicine, University of Reading 
• Carolina Mendoza-Topaz, Senior Research Scientist, AstraZeneca
  
  

February 2022

Discussion Topics:

• Presentation: Streamlining Stem Cell Manufacturing by Ajan Reginald, Chief Executive Officer at Celixir
• 2D vs 3D culture systems
• Batch sizes
• Importance of process for phase I
• Analytical assays

Discussion Group Leaders:

• Ajan Reginald, Chief Executive Officer, Celixir 
• Lior Raviv, Chief Technology Officer, Pluristem Therapeutics

December 2021

Gene therapy development must be fast and efficient. Automation is one of the main priorities affecting the cell and gene industry today to expedite the next-generation development. By following established platforms consisting of common raw materials, parent cell lines, unit operations, and drug substance formulations, automated processes should deliver an intensified procedure for cell therapy development. Challenges remain, however, and in our next cell discussion group we bring together an exclusive panel of key opinion leaders to discuss the key factors behind the market’s growth, priorities, future outlook & challenges.

Discussion Points: 

• Challenges and gaps in technology innovation in cell and gene therapy  
• Opportunities: transition for available advanced technology in biologics and pharma products to cell and gene therapy  
• Operational hurdles and how to justify business impact 
• User requirements and key area of focus (e.g., automation) 
• Benefits of technology innovation in cell and gene therapy (business impact) 
• Promoting cross-industry collaboration
   

Panel Structure: 

• Moderator: Udayanath Aich, Associate Director, Bristol Myers Squibb 
• Panellist: Michael Delahaye, Director and Team Leader Cell Therapy Bioprocessing, AstraZeneca 

November 2021

The question of how best to advance technological strategies for viral vector-based gene therapy is an increasingly prevalent and important one. Our first-ever Cell series discussion group aims to delve into the challenges and opportunities of viral vector manufacturing and delivery. This live session brings together experts to look at the latest developments in the field for an hour of a discussion on design and purification techniques, immunogenicity concerns, and characterisation.

Panel Discussion: Bridging The Gap In the Manufacturing Viral Vectors and Viral Vector Based Gene Therapy

• Designing viral vector delivery to elicit same process
• Increase yield of viral vectors
  • Purification techniques
• Immunogenicity concerns
• Characterisation of viral vectors

Moderator:

John Moscariello, Executive Director Viral Vector and Gene Editing Process Development, Bristol Myers Squibb

Panellists:

Blair Madison, Senior Director, Genetic Engineering, Poseida Therapeutics

Francesca Vitelli, VP, Cell Therapy and AAV Process Development, Intellia Therapeutics

Kyle Grant, Director of Vector Production, Voyager Therapeutics