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Preventing and Responding to Microbial Contamination of Cellular Therapies

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

Thursday, April 19, 2018
2:00 – 3:00 PM (ET) 7:00 – 8:00 PM (GMT)
Master Program Number: 18EL-329 (see program format numbers below under Registration)

Educational Track: Technical/Clinical
Topic: Cellular Therapies
Intended Audience: COOs, Laboratory Staff, Managers/Supervisors, Medical Directors, Students (MD, MT, SBB) Technologists, Transfusion Safety Officer
Teaching Level: Intermediate

Director/Moderator: J. Wade Atkins, MS, MT(ASCP) SBB, CQA(ASQ), Supervisor, QA and RA, Dept. of Transfusion Medicine, Clinical Center, NIH, Bethesda, MD
Speakers: Angela Ondo, MT(ASCP), Quality Assurance Manager, BMT Program and Cell Therapy Laboratory, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, MD; Sandhya Panch, MD, MPH, Staff Clinician, Cell Processing Section, Department of Transfusion Medicine, Clinical Center, NIH, Bethesda, MD

Learning Objectives

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

  • Implement or modify if needed, strategies or protocols intended to prevent contamination or cross contamination of Human Cells or Tissue Products (HCT/Ps).
  • Apply an algorithmic approach to determining the risk of distributing an HCT/P product with a positive sterility assay result.

Program Description

There are many challenges to manufacturing sterile cellular therapy products intended for human use. Even with facility engineering and operational administrative procedural controls in place there are occasional positive sterility assay results.  Evaluating these results and determining the risk assessment of the benefit to the patient versus the risk of introducing a communicable disease can be difficult in real time.

This program will review strategies for assuring aseptic processing during manufacturing to prevent contamination or cross contamination and will also discuss systematic approaches to evaluating the available information to determine risk to benefit for infusing the product with a reported positive sterility assay.

Registration

   Program #
Single Viewer: Live Register18EL-329-2070
Single Viewer: On-Demand Register18EL-329-4070
Group Viewing: Live Register18EL-329-6070
Group Viewing: On-Demand Register18EL-329-8070
Group Viewing: Live & On-Demand Register18EL-329-9970

Speaker Biographies

Angela Ondo, MT(ASCP) is the Quality Assurance Manager for the BMT Program and the Cell Therapy Laboratory at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland. Her responsibilities include overseeing regulatory and quality of donor screening, collections and processing of 351 and 361 HCT/P products. Prior to this, Ms. Ondo was a Quality Assurance Officer in the Blood Donor Center at the Johns Hopkins Hospital.

Dr. Sandhya Panch is the Medical Director at the National Institutes of Health, Cell Processing Section in the Department of Transfusion Medicine. She is clinically trained in Hematology/Oncology and Transfusion Medicine. Her responsibilities include supervising the various divisions of the section. She also guides program design, research safety, and budget development.