Spotlights 2023

Cell Therapy Materials & Upstream Processing/Analytics


Cell Therapy Materials & Upstream Processing/Analytics

  • Cell therapy raw and starting materials
    • Optimizing cell collection, CQA identification and testing, and control of autologous cell therapy starting materials
    • How can we grow our currently limited understanding of the impact of donor materials on allogeneic cell therapies, and how to account for donor variability?
    • Challenges and opportunities in starting materials supply for induced pluripotent stem cell (iPSC)-derived cell therapies
    • Meeting the need for robust analytics to meet the ever-increasing expectations of regulators around cellular starting materials quality
    • Assessing upstream supply chain/logistics tools and technologies
  • Cellular immuno-oncology manufacturing business models
    • Is it best to pursue an in-house or an outsourced commercial manufacturing strategy?
    • Cost of goods and manufacturing timeline/complexity reduction
    • Centralized versus decentralized manufacturing – what’s shaping future strategy?
  • Comparing and contrasting upstream cell processing tools and devices
  • Which tools are delivering required gains in productivity and quality?
    • What is the latest in closed, automated upstream processing system innovation?
      • How effectively are long-standing issues of technology integration and interoperability being addressed?
      • How adaptable are current ‘all in one’ manufacturing devices in practical application?
    • Assessing the state of the art – and future innovation needs - in cell sorting/separation and enrichment
    • Optimizing upstream process analytics
  • Analyzing trends in the cell therapy CDMO sector – what do they mean for industry, and for the field in general?