Implementation of the ISO Cell Counting Standards
The Standards Coordinating Body (SCB), in collaboration with the International Society for Cell & Gene Therapy (ISCT), launched the "Implementation of the ISO Cell Counting Standards". This on-demand course that teaches participants how to implement the ISO Cell Counting standards to enhance the quality and comparability of their cell counting processes.
The course was developed with input from the Subject Matter Experts (SMEs), including NIST, FDA, and device manufacturers, who helped create the ISO 20391-1:2018 (Part 1) and ISO 20391-2:2019 (Part 2) Standards.
The course would be beneficial for individuals involved in manufacturing or research roles that involve cell counting, including:
Individuals in product quality, regulatory, or other related roles looking to improve their cell counting process
Manufacturers looking to increase reproducibility between operators and sites
Academics developing therapies intended for future commercialization who want to learn best practices for data collection to enable a smooth tech transfer process
Individuals looking to increase their knowledge and marketable skills for career advancement within the regenerative medicine and advanced therapies fields
To gain the knowledge and tools necessary for designing precise and reproducible cell counting processes, we encourage you to learn more about our on-demand course and register here.
July 21-22, 2025 - Hands-On SCB ISO Cell Counting Implementation Course
On July 21-22, 2025, SCB, in collaboration with experts from NIST, is offering a Hands-On ISO Cell Counting Implementation course at Montgomery College Germantown Campus in Maryland, 20 miles north of Washington, DC. This course is designed to supplement the on-demand , "Implementation of the ISO Cell Counting Standards" Course and will consist of two full days of in-person learning.
Day 1 - ISO 20391-1:2018, Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
Learners will apply the concepts from the standard to prepare samples and collect a full data set using several types of cell counting equipment (e.g., flow cytometer, hemocytometer, automated cell counter).
Day 2 - ISO 20391-2:2019, Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance
Learners will be trained to use the ISO standard-based, NIST-designed COMET analytical tool and evaluate the data they gathered on Day 1 to learn how to:
Perform the statistical analysis described in the ISO standard, including comparison and evaluation of methods, cell counts, and viability
Provide the information needed to meet regulatory reporting requirements
Compile experiment metadata
The hands-on course and electronic copies of both part 1 and 2 of the ISO Cell Counting Standard are included free of charge if you register now for or have already completed the self-paced online course. The cost to take this course without completing the self-paced ISO Cell Counting Course is $600. This fee includes the cost of consumables and the ISO Cell Counting Standards. Register for the Hands-On SCB ISO Cell Counting Implementation Course here.
FDA Recognition of the ISO Cell Counting Standards
The two-part ISO Cell Counting Standard, part 1, ISO 20391-1:2018, General guidance on cell counting methods and part 2, ISO 20391-2:2019, Experimental design and statistical analysis to quantify counting method performance has been recognized by the FDA’s Center for Biologics Evaluation and Research (CBER), as part of their Voluntary Consensus Standards (VCS) recognition program. CBER encourages the use of appropriate standards in the development of CBER-regulated products. VCS, such as the ISO Cell Counting Standard, can assist stakeholders in meeting regulatory requirements more efficiently and increasing regulatory predictability for regenerative medicine therapy (RMT) products.