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Day 3 - Flow Cytometry Standards Consortium Public Workshop

Friday, November 3, 2023 – 8:30 am to 5:00 pm ET



Time Topics

8:30 am – 8:40 am

Welcome & Opening Remarks

8:40 am – 9:00 am


Overview of Current NIST Advanced Therapy Program

9:00 am – 10:10 am


FDA’s perspectives on standardization of flow cytometry measurements for cell and gene therapies

9:00 am – 10:10 am


NIST Flow Cytometry Standards Consortium

  • Consortium overview
    • WG1: Instrument Standardization
    • WG2: Assay Standardization
    • WG3: Data Standards
    • Planned WG4: Gene Delivery


Updates on documentary standards on flow cytometry for cell and gene therapy products

  • EU perspective on flow cytometry standards
  • Flow cytometry documentary standards from CLSI
  • Update of related efforts - tbd

12:00 – 1:30 pm

Lunch Break

1:30 – 2:30 pm

Needs, gaps, and opportunities for the use of flow cytometry for cell and gene therapy

  • Quality control of raw materials
  • Potency
  • Cytotoxicity
  • Off target genome editing
  • In vivo cell engineering

2:30-3:00 pm

Moderated discussion on future actions/activities addressing unmet needs and challenges

3:00 – 3:20 pm


3:20 – 4: 40 pm

New Technology Showcase (participant to be announced)

4:40 pm

Future consortium activities & summary of consortium study impact, next steps, and closing remarks

5:00 pm


Created September 6, 2023, Updated September 18, 2023