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Flow Cytometry Standards Consortium Workshop

Workshop slides are now available:
Day 1      Day 2      (PDFs)

NIST is establishing a Flow Cytometry Standards Consortium to accelerate the adoption of quantitative flow cytometry in biomanufacturing of cell ad gene therapies.

The purpose of this workshop is to launch and inform future directions of the Flow Cytometry Standards Consortium. Participants will learn about state-of-the-art in flow cytometry applications, help to identify pressing measurement challenges and standards needs, and provide initial feedback on the proposed directions of the Consortium. Future meetings of the Consortium will further refine and implement Consortium plans.

 

Agenda

Day One 

Tuesday, February 16, 2021 | 12:00 to 4:00 pm Eastern Standard Time 

12:00 PM –12:15 PM

Welcome and Overview of NIST Advanced Therapy Program

Sheng Lin-Gibson, Ph.D. (NIST)

12:15 PM – 12:30 PM

NIST Flow Cytometry Program Overview

Lili Wang, Ph.D.  (NIST)

12:30 PM –12:50 PM

FDA’s Perspectives on Standardization of Flow Cytometry Measurements for Cell and Gene Therapy Products

Steve Bauer, Ph.D. (FDA)

12:50 PM–1:50 PM

Overview of Existing Standardization Efforts 

Moderator: Lili Wang


a. Flow cytometry standards/RMs/methods

Sandrine Vessillier, Ph.D. (NIBSC)


b. Flow cytometry documentary standards

Virginia Litwin, Ph.D. (CLSI)


c. Coordination of standards for regenerative medicine

Dawn Henke, Ph.D. (Standards Coordinating Body)


 

1:50PM – 2:00PM Break
2:00 PM –3:20 PM

Needs and Gaps for Flow Cytometry used in Cell and Gene therapy

Moderator: Paul DeRose, NIST


a. Advanced cell manufacturing 

Simon F. Lacey, Ph.D. (UPenn)


b. Autologous/allogenic CAR-T manufacturing

Xiuyan Wang, Ph.D. (MSKCC)


c. Anti-tumor cell therapy manufacturing

Melissa Myint, Ph.D. (Mana Therapeutics)


d. Disease diagnostics/Vaccine development

Bruce Davis, Ph.D. (Cytometry Assay Development Consultant)

3:20PM – 4:00 PM

Open Discussion on Measurement and Standardization Needs and Gaps

Pre-workshop survey results/live comments & questions

Lili Wang and Day-One presenters

4:00 PM Adjourn for the day. 

Day Two 

Wednesday, February 17, 2021 | 12:00 to 4:00 pm Eastern Standard Time 

12:00 PM – 12:10 PM

Workshop Day-One Summary and Goal setting for Day-Two

Sumona Sarkar, Ph.D. (NIST)

12:10 PM –1:10 PM

NIST Flow Cytometry Standards Consortium – Consortium and Working Group objectives

Moderator: Tara Eskandari, NIST


a. Reference Materials 

Lili Wang, Ph.D. (NIST)


b. ERF Measurement Service

Paul DeRose, Ph.D. (NIST)


c. Flow Cytometry Measurement Protocols

John Elliott, Ph.D. (NIST)


 

1:10 PM – 1:20 PM

Break
 

Technology/Capability Showcase of Companies*

Moderator: Paul DeRose

1:20 PM – 1:30 PM

 Solutions for Consistent Cell Therapy Manufacturing

Anagha Divekar, (BioLegend)

 

1:30 PM – 1:40 PM

Is digital flow cytometry the future?

J. Paul Robinson, (Miftek Corp.)

 

1:40 PM – 1:50 PM

Precision genetic device engineering with TASBE Flow Analytics 

Jake Beal, (Raytheon BBN Technologies)

 

1:50 PM – 2:00 PM

FlowCytes - Synthetic Reference Cells for Calibration, Traceability and Standardization

Jeffrey Kim, (Slingshot Biosciences)

 

2:00 PM – 2:10 PM

AmberGlass Technology - an approach to standardization of complex multiparametric flow cytometry assays

Bala Manian, (Mojave Bio)

 

2:10 PM – 2:20 PM

Standardization of Flow Cytometry Instrumentation and Methodology for Assessment of Absolute Count Accuracy

Garret Guenther, (Agilent)

 

2:20 PM – 2:30 PM

Presentation Title: Fluorescent Microspheres for Flow Cytometry Calibration and Standardization ​

Yu-Zong Zhang, (Thermo Fisher Scientific)

 

2:30 PM – 2:40 PM

Single Vesicle Flow Cytometry (vFCTM): Rigorous and Reproducible Extracellular Vesicle (EV) Measurement

John Nolan, (Cellarcus)

 

2:40 PM – 2:50 PM

Unitized flow cytometry antibody panels for standardized multi-site studies

Eda Holl, (Beckman Coulter Life Sciences)

 

2:50 PM – 3:50 PM

Consortium Strategy, Including Near-term and Long-term Goals of the Consortium/Working Groups

Moderator: John Elliott

All Presenters 

3:50 PM – 3:55 PM

Next steps and Closing Remarks

Lili Wang

3:55 PM Adjourn. 

 

*NIST will select companies with unique capability/products that can address the identified critical needs and can be utilized in starting consortium project(s)

Created January 6, 2021, Updated February 25, 2021