SCB Launches  In-Person Standards Implementation Course

Standards provide many benefits to regenerative medicine product manufacturers; however,  manufacturers may have questions about how to apply a given standard to their own product workflow. To address this need, SCB is working with NIST to develop a series of standards implementation courses focused on recently released standards for regenerative medicine.

SCB’s latest offering is a 2-day in-person course focused on practical application of the FDA-recognized ISO cell counting standards ISO 20391 part 1&2.

About the 2-Day Course

The course consists of two full days of instruction—July 21-22, 2025—at Montgomery College’s Germantown Campus in Maryland, 20 miles north of Washington, DC.

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

Note: This course is a follow-up to the self-paced course that SCB launched, available online via the ISCT platform, that also focuses on ISO 20391 parts 1 and 2.

Who Should Attend?

The course is suitable 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

How to Register

Learners may register for the in-person course online.

• In-person course participants should have basic laboratory skills.

• The in-person course has a participant cap of 12 people.

• Take both courses and save: If you register now for or have already completed the self-paced online course, you may register for the in-person course for free (a $600 savings); all others will be charged a $600 fee, which includes a copy of each standard.

Benefits of the In-Person Course

While the initial online course provides a comprehensive understanding of how to use the cell counting standards, the follow-up in-person course will:

• Teach you how to apply the concepts of the online course to your own work

• Give you a chance to compare measurements to other learners and identify key sources of measurement variability

• Allow you to ask questions in real time and get feedback to ensure you are applying the standard correctly

• Offer you a rare opportunity to learn directly from NIST’s leading experts in metrology

• Provide you with hands-on experience with the state-of-the-art equipment at Montgomery College’s biotechnology facility

Value of the ISO Cell Counting Standards

Because the main component of cell and gene therapies is the cells themselves, cell counting methods that are reliable and reproducible are critical to ensuring a safe and effective dose.

ISO 20391 Parts 1 and 2:

• Provide key considerations to help therapy manufacturers assess and improve the performance and consistency of their cell counting methods

• Are recognized under the FDA CBER Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT), indicating that they are standards the FDA will accept during regulatory reviews

Get Involved

• Register now to attend this unique in-person course; space is limited to 12 participants.

• Can’t attend? SCB plans to offer additional instances of this course in the future. Please contact SCB to be notified when the next course is available or to let us know if you would be interested in hosting a course at your facility or event.

• Interested in a private, in-house version? Contact SCB if you are a manufacturer or academic center interested in hosting a private version of the course tailored to your equipment, product, and processes.