Is IDM Testing of Autologous Donors Protecting Anyone? Rethinking Manufacturing Safety Controls (26EL-642)

Please note: AABB reserves the right to make updates to this program.

• Educational Track: Technical/Clinical
• Topic: Biotherapies
• Intended Audience: CEOs, CFOs, COOs, Directors, Donor Recruitment Staff, Hospital Blood Banks, Hospitals, Laboratory Staff, Managers/Supervisors, Medical Directors, Nurses, Physicians, Research Scientists, Residents/Fellows, Scientists, Students (MD, MT, SBB), Technologists, Transfusion Safety Officers
• Teaching Level: Advanced, Intermediate

• Director/Moderator: Wanxing Cui, MD, PhD, CABP(H), Director, Cell Therapy Manufacturing Facility, MedStar Georgetown University Hospital, Washington, DC
  Speakers:

  • Wanxing Cui, MD, PhD, CABP(H), Director, Cell Therapy Manufacturing Facility, MedStar Georgetown University Hospital, Washington, DC
  • Eapen Jacob, MD, Consultant Division of Transfusion Medicine, Associate Professor of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN
  • Zack Thompson, MD, FCAP, CABP, Senior Associate Consult, Medical Director of Human Cell Therapy Lab, Assistant Professor of Laboratory Medicine, Mayo Clinic College of Medicine and Science, Jacksonville, FL

• Program Description

  This program challenges the conventional application of allogeneic infectious disease marker (IDM) testing standards to autologous cell therapy donors. Despite fundamental differences in risk profiles between allogeneic and autologous therapies, current regulations often mandate extensive IDM testing for autologous donations, creating a significant misalignment between scientific rationale and regulatory requirements.

  The program will address a critical knowledge gap in understanding how current testing practices may actually hinder patient care by creating unnecessary barriers to treatment while contributing minimal value to manufacturing safety or personnel protection. Through case studies and expert analysis, participants will examine evidence demonstrating how these requirements delay therapies, increase costs, and potentially compromise patient outcomes without proportional safety benefits.

  Industry experts will share experiences implementing modified testing protocols while maintaining GMP compliance and personnel safety. It will explore risk-based alternatives better aligned with autologous therapy principles and provide practical strategies for maintaining appropriate manufacturing safety measures without imposing unnecessary testing burdens on patients receiving their own cells.

  Learning Objectives

  After participating in this educational activity, participants should be able to:

  • Evaluate the scientific rationale behind current IDM testing practices for autologous cell therapy donors and identify gaps between regulatory requirements and risk-based evidence.
  • Analyze the effectiveness of alternative manufacturing safety controls in autologous cell therapy production and compare their risk profiles with traditional testing approaches.
  • Develop evidence-based strategies for implementing appropriate safety measures while reducing unnecessary donor testing burdens.

  Registration

  Registration includes access to both the live and on-demand version of this eCast.

  If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team approximately one week prior to the live program (each team member to register for the program utilizing a promocode). For single viewers, simply click on the Register button below to register.

  Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time, you will receive access to the on-demand eCast when it is available.

  Single Viewer	Register
  Group Viewing	Register

  Continuing Education Credit

  This activity is eligible for one (1) continuing education credit/contact hour for Physicians, California Nurses, California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage.

  There is no financial support for this activity.

  

  In support of improving patient care, this activity has been planned and implemented by the Association for the Advancement of Blood & Biotherapies (AABB), which is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

  Physicians (ACCME): AABB designates this live activity for a maximum of one (1) AMA PRA Category 1 Credit^TM. AABB designates this enduring activity for a maximum of one (1) AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  Claiming Credit
  Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.

  Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).

  Program & Credit Expiration Dates:

  • Live Activity Program Date: June 10, 2026; Credit Expiration Date: July 10, 2026
  • Enduring Activity Program Dates: June 10, 2026 – June 9, 2029; Credit Expiration Date: June 9, 2029

  Disclosure Declaration

  It is the policy of the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of its CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. AABB has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.

  Disclosures for the planners of this event can be found here. Disclosures for the program faculty, peer reviewers, and AABB personnel are provided at the beginning of the program.

  Faculty Biography

  Dr. Wanxing Cui is the Director of the Cell Therapy Manufacturing Facility at MedStar Georgetown University Hospital, where he oversees an FDA-registered operation adhering to standards set by the AABB, CAP, and FACT. With over 27 years of experience in pancreatic islet transplantation, he has significantly contributed to the Pancreatic Islets and Stem Cell Transplant and Cellular Immunotherapy programs at the hospital. Dr. Cui earned his Ph.D. in Molecular Medicine from Kyoto University, Japan, focusing on developing a bioartificial pancreas. He has authored over 70 peer-reviewed publications and holds several biotechnological patents. An active AABB assessor and FACT inspector, he contributes to advancing cell therapy standards. Additionally, he participates in the ISCT's iPSC Joint and Lab Practice Committees and serves as a mentor in ISCT's Professional Education Program (PEP) and AABB's Early Stage Professionals (ESP) programs. Dr. Cui is also a member of the AABB Cellular Therapies Section Coordinating Committee (CTSCC), furthering advancements in cell therapy.