Course Syllabus

The Implementation of Cell Counting Standards Course

The course comprised ten modules for approximately 12 hours of learning. Each module consists of a training video and a knowledge check (quiz). The last module of the course is the final examination consisting of 50 multiple-choice questions.  

Learners have one attempt to complete and pass the final examination in order to obtain the course completion certificate. 

Any learner who failed the final assessment may pay $250 USD to retake the course and examination once more. Please note that the re-examination fee must be paid within 30 days of the failed exam date. 

Module 1: Overview & Basics of Standards

Speaker: Dawn Henke, Ph.D., Senior Scientific Program Manager, SCB

1 Hour On-Demand Module

Learning Objectives

  • Understand and use cell counting terminology.

Topics Covered

  • Course Objective and learning goals.
  • What are the consensus standards?
  • Specific language used in the standards.
  • What standards are.
  • Language used in the standards ("should", "shall", "can", "may").

Module 2: Standards and the Regulatory Process

Speaker: Richard McFarland, M.D., Ph.D., Chief Regulatory Officer, ARMI/BioFabUSA President, SCB

1 Hour On-Demand Module

Learning Objectives

  • Understand the impact of the standards on meeting regulatory requirements. 
  • Understand and use cell counting terminology.

Topics Covered

  • The benefits of communicating directly with the FDA early in the process.
  • The regulatory process and its importance.
    • Expectations for IND application before clinical trial.
    • Expectations for BLA.
  • The benefits of the use of the standards in the regulatory process.
  • Guidance and best practices for the regulatory process. 

Module 3: Fit-for-Purpose Methods

Speaker: Sumona Sarkar, Ph.D., National Institute of Standards and Technology Biosystems and Biomaterials Division | Biomaterials

1 Hour On-Demand Module

Learning Objectives

  • Select a best-fit method for cell counting, by:
    • Understanding the science of cell counting methods.
    • Understanding the goals of cell counting methods.
    • Understanding the types of cell counting methods.
  • Understand and use cell counting terminology.

Topics Covered

  • How cell counts are used at various stages.
  • The science of cell counting.
  • Types of cell counting methodologies.
    • Total cell counting.
    • Differential cell counting.
    • Direct cell counting.
    • Indirect cell counting.
  • Common cell counting methodologies.
  • Fit-for-purpose.
  • Cell sample composition.

Module 4: Considerations for Selecting a Cell Counting Methodology

Speakers: Mary Q. Stewart, Ph.D.,  Director of Biotechnology Innovation Center (BIC), Scientific and Training Operations, University of New Hampshire--Manchester

Leo Chan, Ph.D., Senior R&D Manager, Nexcelom/Perkin Elmer

1 Hour On-Demand Module

Learning Objectives

  • Select a best-fit method for cell counting, by:
  • Understanding the variations in cell types and sample properties.
    •  Making the appropriate considerations when selecting a cell counting method.

Topics Covered

  • Considerations associated with the cell sample.
  • Considerations associated with the cell counting measurement process.
  • Factors applicable to/involved (causes of variably) in risk assessments.
  • Cell sample images.
  • Cell counting precision and variation.

Module 5: Experimental Design for the Cell Counting Measurement Process

Speakers: Laura Pierce, Ph.D., National Institute of Standards and Technology, Biosystems and Biomaterials Division | Biomaterials 

Mary Stewart, Ph.D., Director of Biotechnology Innovation Center (BIC), Scientific and Training Operations, University of New Hampshire-Manchester

1 Hour On-Demand Module

Learning Objectives

  • Design a plan for quantifying the cell counting method performance, including:
    • Selecting the appropriate number of replicate test samples and measurements and the range of dilution fractions and the target fractions.
    • Identifying what pre-assessment studies and activities are appropriate.
  • Understand statistical analysis as.
  • Understand and use cell counting terminology.

Topics Covered

  • Goals and importance of an experimental design for the cell counting measurement process.
  • Uses and limitations of an experimental design for cell counting.
  • Components and decisions made in the design.
    • The range of dilution fraction.
    • The number of samples and the target dilution fraction for each sample.
    • The number of independent replicate test samples.
    • The number of replicate measurements for each test sample.
  • Considerations for when to conduct pre-assessment studies and activities.

Module 6: Statistical Analysis to Evaluate the Quality of a Counting Measurement Process

Speakers: Sumona Sarkar, Ph.D., National Institute of Standards and Technology Biosystems and Biomaterials Division | Biomaterials 

David Newton, Ph.D., Mathematical Statistician, National Institute of Standards and Technology

Steven Lund, Ph.D., Mathematical Statistician, National Institute of Standards and Technology

1 Hour On-Demand Module

Learning Objectives

  • Understand the statistical analyses in the standards.
  • Perform a statistical analysis on the cell count results to determine the quality of the cell measurement process, including:
    • Applying the formula and selecting the inputs used to calculate the mean cell count for each test sample.
    • Applying the formula and selecting the inputs used to calculate the fit to the proportional model.
    • Applying the formula and selecting the inputs used to calculate the proportionality index (PI).
  • Apply the appropriate considerations when interpreting and extrapolating from the results of the statistical analysis.
  • Understand the limits of the statistical results and conclusions.
  • Understand and use cell counting terminology.
  • Understand and use the statistical language used in the standards.

Topics Covered

  • Goals and importance of a statistical analysis.
  • Quality indicator calculated and use.
  • Mean cell count.
  • Measurement precision.
  • Proportional model fit and coefficient of determination.
  • Proportionality index.

Module 7: Comparing Cell Counting Methodologies/Multiple Counting Measurement

Speaker: Leo Chan, Ph.D., Senior R&D Manager, Nexcelom/Perkin Elmer

1 Hour On-Demand Module

Learning Objectives

  • Perform a statistical analysis on the cell count results to determine the quality of the cell measurement process, including:
    • Applying the formula and selecting the inputs used to calculate the mean cell count for each test sample.
    • Applying the formula and selecting the inputs used to calculate the fit to the proportional model.
    • Applying the formula and selecting the inputs used to calculate the proportionality index (PI).
    • Apply the appropriate considerations when interpreting and extrapolating from the results of the statistical analysis.
    • Compare the results of different cell counting methodologies.
    • Understand and use cell counting terminology.

Topics Covered

  • Single measurement process.
  • Raw measurement data.

Module 8: Reporting

Speaker: Sumona Sarkar, Ph.D., National Institute of Standards and Technology, Biosystems and Biomaterials Division | Biomaterials 

1 Hour On-Demand Module

Learning Objectives

  • Write a report documenting the cell counting methodology followed, the results of evaluating the cell counting quality, and any changes and adaptations made to the plan.
  • Understand and use cell counting terminology.

Topics Covered

  • Clear and consistent reporting.
  • Minimal reporting requirements.
    • Quality indicators.
    • Standardized format for reporting cell concentration.
    • Documentation on the experimental design.
    • Documentation on the statistical analysis.
    • Documentation of deviation/changes from the standard.
  • Best practice elements:
    • Additional expressions of cell count.
    • Experimental design and statistical analysis.
    • Cell counting measurement process.

Module 9: Standards Requirements, Limitations, and Exceptions 

Speaker: Heather Hayes, Ph.D., Product Manager, Axion Biosystems

1 Hour On-Demand Module

Learning Objectives

  • Understand the scope of the standards.
  • Understand the requirements of the standards.
  • Understand the limitations of and the exceptions to the standards.

Topics Covered

  • When to apply the scope of the standards.
  • Summarize the requirements of the standards.
  • Discuss the limitations and the standards and the options.

Module 10: Resources & Evaluation 

Speaker: Catherine Zander, PhD, Director of Standards Education & Outreach, Standards Coordinating Body (SCB)

1 Hour On-Demand Module

Topics Covered

  • Summarize learning key points.
  • Course resources.