Bringing Flow Cytometry to Life: Applications in Cellular Therapies Course

This course is offered entirely online as independent, self-paced study through AABB’s Education Platform. After registering for the course, each learner will receive automatic access to the program. Access is granted for 1 year from the date of registration.

Fees

Individual Registration Pricing:

• AABB Individual Member: $395
• Individual Nonmember: $450

Discount for Multiple Registrations:

• Institutions will receive 15% off the list price when purchasing 4 or more registrations. The list price for each individual student will be determined by the institution’s AABB membership status (not each individual’s membership status).

Discount for Fellows/SBB Students

How To Register

Individuals can register online via the AABB Store. Individuals will be prompted to create an account if they do not already have an established account in the Store. Payment confirmation will be provided immediately after registering.

Institutions that want to purchase registrations for learners must complete and return the Institutional registration form. Payment confirmation will be provided within 2-5 business days.

The learning objectives are provided per Section:

Section 1: Foundational Concepts in Flow Cytometry
Understanding of flow cytometry technology, function and processes involved in sample preparation and measurement is important to ensuring consistent and reliable results. This section describes the technology and the ways in which flow cytometry can be optimized for CT products.

Following completion of this section, students should be able to:

• Discuss the concept of targeting cell surface markers with antibody-fluorochrome conjugates.
• Identify and describe the essential technical components of a flow cytometer assay.
• List the major practical steps in assay setup and performance.
• Explain how event data are gathered and analyzed.

Section 2: Cell Therapy Applications Using Flow Cytometry in the Cell Processing Laboratory
There are a variety of methods to apply flow cytometry to a range of different CT products. This section presents information on application of current flow cytometric methods to a variety of cell types serving both as current practices information as well as an introduction to methods that may prove useful in thinking about approaches to other flow strategies for future products. This section presents examples of how flow cytometry is used in a variety of applications.

Following completion of this section, students should be able to:

• Match cell(s) of interest with their corresponding CT product type.
• Discuss how to set up and optimize a flow panel for staining cells based on CT product to be evaluated.
• Identify cell types based on flow cytometric characterization.
• Describe gating strategies used to distinguish and quantify cell populations of interest on flow cytometer dot plots.
• Enumerate cell populations of interest based on flow cytometric analysis.

Section 3: Review of Concepts – Applying What You Have Learned
Standardization of flow cytometry testing is very important for delivery of consistent quality CT products, particularly with the increase in multi-center trials. With development of some cell types there may not be a “one size fits all” approach, but there are general points to consider in standardization. This section pulls the concepts together testing your knowledge and things to consider in a series of exercises providing feedback.

Following completion of this section, students should be able to:

• Recognize cellular and flow cytometric characteristics that are critical to understanding the properties of cells.
• Formulate an approach to designing flow cytometry panels to assess various cellular therapies.
• Describe a general approach to gating strategies.
  
  

Read and study all materials for each section, including additional readings that support and reinforce basic information presented. Take time to answer questions that ask you to reflect on the material. Follow the sections in order as information builds on preceding lessons. Since this is a self-paced program, learners may decide how much time is needed to review and study the materials. It is estimated the course will take approximately 4-6 hours to complete.

This program is eligible for 6 continuing education credits/contact hours for General Participation, California Lab Personnel or Florida Lab Personnel. The number and type of credits awarded for this program was determined by the estimated program completion time. This course is not eligible for continuing education credit for physicians or California Nurses. For more information on each credit type please visit our Continuing Education Credits webpage. A continuing education certificate of completion will be immediately provided to learners upon reviewing all 3 sections of the course and completion of the course evaluation.

Andrew Fesnak, MD, Director, Cell Manufacturing & Development, Clinical Cell & Vaccine Production Facility, University of Pennsylvania, Philadelphia, PA

Dr. Fesnak is a transfusion medicine physician and cell therapy researcher at the University of Pennsylvania Perelman School of Medicine. He is the director of Cell Manufacturing and Development in the Clinical Cell and Vaccine Production Facility. He shares medical oversight of the Apheresis Clinic and leads a manufacturing group dedicated to developing next generation cell therapies.

Steven Highfill, PhD Research and Product Development Supervisor, Center for Cellular Engineering (CCE) at National Institutes of Health (NIH), Bethesda, MD

Dr. Highfill leads Chemistry, Manufacturing, and Controls (CMC) activities for new cell therapy products ─ building and managing project plans to achieve clinical manufacturing goals that support NIH Clinical Center Investigational New Drugs (INDs). Collaborating with Clinical Center investigators, clinical research managers, and regulatory agencies, Dr. Highfill assures that processes and assays are developed in compliance with FDA regulations to produce consistent biological products. The CCE is located within the Clinical Center of NIH and currently supports >50 active INDs from investigators within, or in affiliation with, the NIH Clinical Center. The clinical trials are predominately Phase I/II, and often first-in-human studies. Products currently in the clinical manufacturing process include T-cells (CART, TCR, virus-specific), mesenchymal stem cells, dendritic cells, natural killer cells, monocytes, and genetically modified hematopoietic stem cells (HSCs).

Emily Hopewell, PhD, MT, Director of Cell & Immunotherapy Manufacturing, Indiana University School of Medicine, Indianapolis, IN

Dr. Hopewell has more than a decade of cellular therapy and laboratory experience. She received a BA in Microbiology and a BS in Clinical Laboratory Science from Miami University in 2002 and 2003, respectively, and obtained her medical technologist certification in 2003. She completed her PhD in cancer biology at the University of South Florida in 2012. Her career in cell therapy began in 2003 at the Moffitt Cancer Center as a technologist processing and analyzing cells for both standard of care and experimental cellular therapies. After completing her PhD, she returned to the Moffitt Cancer Center Cell Therapy team as a development specialist, then as assistant director. She is currently the director of cell and gene therapy manufacturing and an assistant clinical professor at Indiana University and is charged with implementing GMP cell manufacturing at Indiana University. She has extensive experience with flow cytometry for both standard of care hematopoietic stem cell therapy, as well as the next generation of cell and gene therapy.

Jo Lynn Procter, MEd, MT, SBB (ASCP), CQA (ASQ), Center for Cellular Engineering, Department of Transfusion Medicine, NIH Clinical Center, National Institutes of Health, Bethesda, MD

Jo Procter earned her BS in microbiology with a medical technology option from Pennsylvania State University in 1979. She worked as a medical technologist for 40 years. She studied blood bank technology at Michael Reese Research Foundation in Chicago, IL, in 1982 and received a Master of Education degree with a concentration in health services from Augusta College in Augusta, GA, in 1989. She began work in the department of transfusion medicine at NIH in 1991 as technical specialist, Immunohematology Reference Laboratory, transitioned to the Cell Processing Section’s Flow Cytometry Laboratory in 2001, and became supervisor of operations for what is now the Center for Cellular Engineering in 2004. Proctor retired from NIH in May 2019.

Suzanne Thibodeaux, MD, PhD, Assistant Professor, Washington University in St. Louis School of Medicine, Saint Louis, MO

Dr. Thibodeaux earned her MD and PhD degrees at the University of Texas Health San Antonio. As part of her graduate work, which involved investigation of tumor immune therapies, she utilized flow cytometry to evaluate immune cell phenotypes and function. She completed a residency in clinical pathology and a fellowship in blood banking and transfusion medicine at the Hospital of the University of Pennsylvania. Dr. Thibodeaux then joined the Department of Pathology and Immunology at Washington University School of Medicine in St. Louis, MO. She is currently medical director of the Cellular Therapy Laboratory and assistant medical director of transfusion services at Barnes-Jewish Hospital. Her clinical and research interests focus on improving cellular therapies from the clinical laboratory perspective, as well as apheresis and transfusion medicine as it relates to cellular therapy.

Contributors

Christina M. Celluzzi, PhD, MS
Senior Manager, Cellular Therapies, AABB, Bethesda, MD

Jose Cancelas, MD, PhD
Director, CEO, University of Cincinnati Hoxworth Blood Center, Division Director, Research, Hoxworth Blood Center, Cincinnati, OH

Jennifer L. Chain, PhD
Science Officer for Cellular Therapies, Oklahoma Blood Institute, Oklahoma City, OK

Magali Fontaine, MD, PhD
Associate Professor, Department of Pathology, University of Maryland, School of Medicine, Baltimore, MD

Carolyn Lutzko, PhD
Division Director Regenerative Medicine and Cellular Therapy, University of Cincinnati Hoxworth Blood Center, Cincinnati, OH

Debra L. Smith, MD, PhD
Associate Medical Director, Oklahoma Blood Institute/Texas Blood Institute/Arkansas Blood Institute/Coffee Memorial Blood Center; Medical Director, Cellular Therapy Laboratory; Medical Director, Cord Blood Program, Oklahoma City, OK