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.
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)
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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. |
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)
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1:10 PM – 1:20 PM |
Break |
Technology/Capability Showcase of Companies* Moderator: Paul DeRose |
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1:20 PM – 1:30 PM |
Solutions for Consistent Cell Therapy Manufacturing Anagha Divekar, (BioLegend)
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1:30 PM – 1:40 PM |
Is digital flow cytometry the future? J. Paul Robinson, (Miftek Corp.)
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1:40 PM – 1:50 PM |
Precision genetic device engineering with TASBE Flow Analytics Jake Beal, (Raytheon BBN Technologies)
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1:50 PM – 2:00 PM |
FlowCytes - Synthetic Reference Cells for Calibration, Traceability and Standardization Jeffrey Kim, (Slingshot Biosciences)
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2:00 PM – 2:10 PM |
AmberGlass Technology - an approach to standardization of complex multiparametric flow cytometry assays Bala Manian, (Mojave Bio)
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2:10 PM – 2:20 PM |
Standardization of Flow Cytometry Instrumentation and Methodology for Assessment of Absolute Count Accuracy Garret Guenther, (Agilent)
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2:20 PM – 2:30 PM |
Presentation Title: Fluorescent Microspheres for Flow Cytometry Calibration and Standardization Yu-Zong Zhang, (Thermo Fisher Scientific)
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2:30 PM – 2:40 PM |
Single Vesicle Flow Cytometry (vFCTM): Rigorous and Reproducible Extracellular Vesicle (EV) Measurement John Nolan, (Cellarcus)
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2:40 PM – 2:50 PM |
Unitized flow cytometry antibody panels for standardized multi-site studies Eda Holl, (Beckman Coulter Life Sciences)
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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)