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EVENTS

NIST-FDA Cell Counting Workshop: Sharing practices in cell counting measurements

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NIST Organizers: Sheng Lin-Gibson, Sumona Sarkar, Clare Allocca
FDA Organizers: Judith A. Arcidiacono, Steven S. Oh, Steven Bauer

NIST and FDA are actively collaborating on projects that address regulatory and measurement challenges for regenerative medicine products and advanced therapies. These collaborations leverage NIST expertise in measurement sciences to address specific analytical scientific challenges as well as FDA regulatory science, research and review expertise in regenerative medicine products to ensure that the science and standards developed address significant regulatory challenges that recur across the field. One of the fundamental challenges for manufacturers of regenerative medicine products is the counting of cells for manufacturing and dosing purposes. This workshop will focus on approaches for selecting appropriate cell counting methods and overcoming gaps in obtaining sufficient measurement assurance for cell counting. The expected outcome of the workshop is a Workshop Summary/Whitepaper to be published in a peer reviewed journal as well as input into standards for cell characterization.

The maximum capacity of this workshop is 50 persons. Meeting participants are expected to actively contribute to the discussions (see Requirements for Meeting Participation). Spaces for meeting observers will be allotted based on availability. This one-day public workshop will be followed by the meetings of the US TAG to ISO/TC 276: Biotechnology. 

 

Cell Counting Workshop report

 

Agenda, Final Participation List, and Presentations

Final Participation List (View PDF)

8:30-9:00am    Registration (West Square, NIST)
                                Breakfast (NIST Cafeteria)                                                                                                      

9:00-9:30am
Welcome remarks NIST           Sheng Lin-Gibson (10 min)                 presentation (View PDF)
Welcome remarks FDA            Judith A. Arcidiacono (10 min)          presentation (View PDF)
Cell counting overview             Sumona Sarkar (10 min)                    presentation (View PDF)

9:30-11:45am (w/15 min break)     Moderator: Judy Arcidiacono (FDA)
Session 1: Users’ forum - cell counting design and validation (30 min each):

Case study 1              Celgene: Michelle McLaughlin                            presentation (View PDF)
Case study 2              CDI: Wen Bo Wang                                                    presentation (View PDF)
Case study 3              Lonza: Joseph Finny
Case study 4              Memorial Sloan Kettering: Brigitte Senechal    presentation (View PDF)

 

11:45am –12:30pm
Round Table discussion                         

  • Design consideration for selecting and establishing a cell counting measurement
  • Minimum data sets to achieve confidence (including validation protocols)
  • Lesson’s learned: what works well: what is missing: what were time sinks?

12:30-1:30pm                 Lunch (on your own, NIST Cafeteria)
1:30-2:45 pm                  Moderator: Steve Bauer (FDA)


Session 2: Device provider’s forum: Precompetitive Considerations (15 min each):

  • Points to consider when establishing a cell counting measurement for the intended

    purpose

  • Cell sample properties that affect cell counting measurements
  • Lessons learned in assisting users to set-up validated counting systems

  • Perspective on major challenges facing cell counting and recommendations

     

Presentation 1                 Beckman Coulter: Lena Lee                     presentation (View PDF)
Presentation 2                 Chemometec: Matthew Riolo                  presentation (View PDF)
Presentation 3                 Fisher Scientific: Mike O'Grady               presentation (View PDF)
Presentation 4                 Nexcelom: Jean Qiu                                     presentation (View PDF)
Presentation 5                 Ovizio: Philip Mathuis                                 presentation (View PDF)

2:45-3:00pm                    Coffee Break (on your own, NIST Cafeteria)

3:00-4:45pm                    Moderator: Sumona Sarkar                       presentation (View PDF)
Session 3: Approaches to overcoming gaps in obtaining sufficient measurement assurance for cell counting

Regulatory considerations for cell counting      Steve Bauer / FDA (15 min)    presentation (View PDF)
Measurement assurance strategies                     John Elliott/NIST (15 min)        presentation (View PDF)

Round Table Discussion

  • Common methods/best practices
  • Reference materials
  • In process controls for the measurement process
  • Other strategies for measurement assurance
  • Documentary standards

4:45-5:30pm  Session 4: Next steps         Moderator:  Sheng Lin-Gibson         presentation (View PDF)

  • Meeting summary
  • Key concepts / outline for whitepaper
  • Other businesses

5:30 pm                                  Meeting adjourned

Bioscience, Bioeconomy, Biomanufacturing, Cell measurements, Biofabrication, Genome editing, Genomics, Health, Cell and gene therapy, Cancer and Regenerative medicine and advanced therapy
Created January 27, 2017, Updated February 26, 2025
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