NIST-FDA Cell Counting Workshop: 

Sharing practices in cell counting 

measurements

NIST Organizers:

Sheng Lin-Gibson

Sumona Sarkar

Clare Allocca

FDA Organizers: 

Judith A. Arcidiacono 

Steven S. Oh

Steve Bauer
Meeting Logistics

Lunch and coffee (NIST cafeteria) 

Group dinner (on your own)

Meeting presentation/discussion format 

Permission to post of meeting materials

“Idea box” for live entry of comments/ideas during session 4

Acknowledgements 

Safety
NIST-FDA Cell Counting Workshop: 

Sharing practices in cell counting 

measurements

Sheng Lin-Gibson, Ph.D.

Director, Regenerative Medicine and Advanced Therapy Programs

Leader, Biomaterials Group

NIST Materials Measurement Laboratory

Phone: 301-975-6765

slgibson@nist.gov

Chair, US TAG to ISO/TC276 Biotechnology

Convenor, WG3 Analytical Methods, ISO/TC 276 Biotechnology
NIST – Who we are today

“Industry’s National Laboratory”

Non-regulatory agency partnering/serving industry to help maintain 

US leadership in science and technology products 

The National Metrology Institute

global harmonization of measurement and traceability to the SI

Department of Commerce

developing standards to support international 

trade and commerce
Bio at NIST 

Develop measurement science, standards, data & 

technology to support development, manufacturing, 

& regulatory approval of biologics (proteins, cellbased therapeutics products, gene therapy products) 

and devices 

• Works closely with stakeholders (biopharma 

industry, FDA, equipment vendors) to identify key 

measurement problems and solutions

• Draws from a broad array of unique, cutting-edge 

expertise, resources, and facilities available at NIST 

• Is a scientifically trusted, impartial 3rd party that 

works to promote cross-industry collaboration & 

open data sharing
NIST Practices

Measurements and Technology

• Develop advanced measurement capabilities

• Improve measurement quality and assurance

Reference Materials /Standards

• Develop and certify NIST SRMs and RMs

• Generate reference data (e.g., chemical spectra)

Standards

• Lead and contribute to documentary standards 

development through SDOs (e.g., ISO, IEC, 

ASTM, etc.)

• Conformity assessment 

• Standards education

U.S. national prototype 

kilogram

NIST synthetic RNA controls 

used in sequencing of Ebola 

virus genomes

6

NIST Monoclonal Antibody 

Reference Material 8671

Yeast Cells as 

a Reference 

Material
Counting Measurements at NIST 

Bacteria (s. mutans)

Gene modified yeast RM as a surrogate 

biothreat detection material

Polymeric RM mimicking the structure and 

characteristics of protein aggregates

SEM of gold nanoparticles 

as RM in biomedical 

research laboratories.

Co nanoparticles for 

medical imaging and 

information storage

PBMCs MSCs

CAR-T

Human cells for therapeutic/medicine use 
NIST/AMTech funded 

industry-driven 

technology consortia that 

establishes technology 

roadmaps to address 

long-term U.S. industrial 

research needs.

8

http://cellmanufacturingusa.org
Dec 16, 2016: U.S. Secretary of Commerce Penny Pritzker Announces 

Biopharmaceutical Manufacturing Institute Joining Manufacturing USA 

Network
NIST Laboratory 

Programs

Standards 

Leadership

Coordination & 

Communication

• Industry engagement 

• USG coordination 

• Convene workshops

• ISO/TC 276 leadership

• ASTM F04 leadership

• Expert contributions to 

SDOs 

• Innovative 

measurement 

solutions

• Industry 

collaborations

NIST Efforts in Cell-Based Medicinal Products 
Bridging the Communication Gap

Oct 25, 2017 NIST-FDA Flow Cytometry Workshop tbd

April 2017 NIST-FDA Cell Counting Workshop Whitepaper expected

July 2016 Cytotherapy Commentary: “Defining quality 

attributes to enable measurement assurance for 

cell therapy products”

Sheng Lin-Gibson and Sumona Sarkar et al., 

Cytotherapy, Volume 18 (10), October 2016, Pages 

1241-1244

May 2016 Genome Editing Standards Workshop http://www.nist.gov/mml/bbd/genes.cfm

Feb 2016 NIST CAR-T Biomanufacturing Symposium Lin-Gibson et al. DOI: 

10.1089/humc.2016.29014.com 

https://www.ibbr.umd.edu/NISTCART

May 2015 NIST Workshop: Strategies to Achieve 

Measurement Assurance for Cell Therapy 

Products 

Simon et al. Stem Cells Translational Medicine 5, 

705-708.

http://www.nist.gov/mml/bbd/biomaterials/meas

urement-assurance-for-cell-therapy-products.cfm

Forum on Regenerative Medicine

NIST Meetings, Workshops, and Commentaries

MATES -

Multi-Agency Tissue 

Engineering Science

NIST Participation/Contribution
FDA-NIST Collaborations on Standards

Leveraging unique expertise 

NIST engages in 

discussions and 

collaborates with industry 

and others on precompetitive technologies 

NIST expertise in 

measurement sciences 

address specific analytical 

challenges

FDA scientific and 

regulatory expertise 

ensure that standards 

- do not conflict with FDA 

regulation and policy 

- address significant 

regulatory challenges that 

recur across the field

Arcidiacono, Lin-Gibson, et al. Cytotherapy. Submitted

Standards 

Development

Workshops and 

Public Meetings

Research 

Collaborations
The ISO/TC 276/WG 3 Analytical methods aims to develop standards 

for accurate, reproducible and robust measurement and analysis in 

support of biotechnology.

• ISO/WD 20391-1&2: Biotechnology - Cell Counting – Part 1. 

General Guidance on Cell Counting Methods

• ISO/WD 20391-1&2: Biotechnology - Cell Counting – Part 2. 

Experimental Design and Statistical Analysis to Quantify 

Counting Method Performance

• Characterization of Cells 

• ISO/AWI 20395 Quality considerations for targeted nucleic acid 

quantification methods 

• ISO/AWI 20688, Biotechnology –Nucleic acid synthesis – General 

definitions and requirements for the production and quality 

control of synthetic nucleic acids. 

• ISO/PWI 20397: Methods to evaluate the quality of massive 

sequencing data

ISO/TC 276: 

Biotechnology* 

Secretariat: DIN

Secretary: Lena Krieger

Chairperson: Ricardo Gent

27 participating countries

13 observing countries

Terms and Definition

Biobanking and 

Bioresources 

Analytical Methods

Bioprocessing

Data Processing and 

Integration 

2-day US TAG meetings to 

immediately follow this workshop
Current status of the TC276 cell characterization 

standard effort 

Cell characterization “umbrella” standard – to enable common 

understanding 

Cell characterization measurement process standard

Cell 

counting

1 & 2

Viability ??

...

Flow 

Cytometry

Gene 

therapy 

products

By attribute By technique

Imaging 

By purpose 

Drug 

discovery

Cell 

therapy 

products

...

By cell type 

??

??

c

Jan 25-26, 2017 US-Japan 

Cell Characterization 

Workshop to develop an 

overarching standard 

Cell Counting Standards are under development; all others are listed as examples 
Workshop Goals

• Raise awareness of the importance and challenges 

associated with cell counting measurements 

• Develop and document best practices for cell 

counting

• Discuss options to address measurement challenges 

through collaborative studies (NIIMBL)

• Workshop outcomes to support the development of 

international standards and more specific 

measurement challenges