What's Special in 2020

Comprehensive Vaccine Assays Stream:

  • Vaccine Regulatory Perspective - Main Workshop 2
  • Vaccine Fit for Purpose (FFP) Validation - Main Workshop 3
  • Clinical Vaccine LBA - T1
  • Vaccine Flow Cytometry Assays & Validation - F2
  • Vaccine ELISpot Assays & Validation - F2

Enhanced Cytometry Stream:

  • Regulatory Perspective - Main Workshop 2
  • CLSI H62 Flow Cytometry Validation - Main Workshop 3
  • Receptor Occupancy/Target Engagement Flow Cytometry Assays - M1
  • Innovation in Cytometry (CyTOF, Imaging, High Dimensional) - entire T2
  • CAR-T QC Flow Cytometry (Updating the 2019 recommendations) - F2

Updated Industry/Regulators consensus on BMV of Biotherapeutics by LCMS:

  • Regulatory Rigor & Acceptance Criteria (Updating the 2019 recommendations)
  • Monitoring BLA submissions to date using LCMS
  • Industry & Regulator experience
  • Scientific (and regulatory) justification for the use LCMS
  • "Minimum requirements" vs "More extensive requirements"