Cellular Therapy Manufacturing: From Starting Material Collection to Drug Product Release

When:  Nov 15, 2022 from 09:00 to 10:30 (PT)

Cellular Therapy Manufacturing: From Starting Material Collection to Drug Product Release

Presented by the ISCT Lab Practices Committee


Webinar Description:

Hematopoietic cells that serve as starting material for cellular therapy drug product manufacturing are typically collected by apheresis. Apheresis collection parameters affect product quality and quantity yet there are currently no standard protocols that ensure efficient and consistent collections leading to various challenges in obtaining the optimal product for further manufacturing. A robust quality management plan with defined acceptance and release criteria are essential to obtaining high quality products that are safe, pure, potent, and effective. In addition, manufacturing of cellular therapy products must comply with federal and state regulations as well as accreditation standards. This webinar explores these aspects of apheresis collection, manufacturing, and regulatory compliance for cellular therapy drug product manufacturing.

Key Learning Objectives:

-Discuss the apheresis collection process and challenges associated with collecting sufficient cells for manufacturing.
- Enumerate quality metrics that help ensure cellular therapy product safety, purity, potency, and effectiveness.
-Describe regulatory and accreditation standards requirements for cellular therapy product manufacturing.

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Yvette Tanhehco, PhD, MD, MS
Director of Cellular Therapy Laboratory
NewYork-Presbyterian Hospital/Columbia University Irving Medical Center
United States


Dr. Yvette C. Tanhehco is an Associate Professor of Pathology and Cell Biology at Columbia University Irving Medical Center (CUIMC) and the Director of the Cellular Therapy Laboratory and Assistant Director of Transfusion Medicine at NewYork-Presbyterian Hospital/CUIMC.

Dr. Tanhehco received her Bachelor of Arts degree in Microbiology and Molecular and Cell Biology from Cornell University in Ithaca, NY. She then received her Doctor of Philosophy degree in Viral Oncology from Johns Hopkins University prior to obtaining a medical degree from the University of Pittsburgh. She completed her residency training in Clinical Pathology followed by fellowship training in Blood Banking/Transfusion Medicine at the Hospital of the University of Pennsylvania. In addition, she obtained a Master of Science degree in Translational Research from the University of Pennsylvania.

Dr. Tanhehco’s clinical and research interests focus on cellular and gene therapies for sickle cell disease and hematologic malignancies. She is particularly interested in strategies to optimize patients and procedures for apheresis collections of hematopoietic progenitor cells and mononuclear cells to minimize patient adverse events and improve cell yields for drug product manufacturing.

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Sarah Nikiforow, MD, PhD
Assistant Professor, Stem Cell Transplantation
Medical Director, Cell Manipulation Core Facility
Technical Director, Immune Effector Cell Program
Dana-Farber Cancer Institute
United States


Dr. Nikiforow is currently an Assistant Professor at Harvard Medical School with the Stem Cell Transplant Program at Dana-Farber Cancer Institute, Medical Director of the Cell Manipulation Core Facility (CMCF), and Technical Director of DFCI’s Immune Effector Cell Program. Dr. Nikiforow earned her MD and a PhD in Immunobiology at Yale University working on the differential roles of CD4 and CD8 T cells in immune control over Epstein-Barr virus-induced B-cell transformation.

Dr. Nikiforow has pursued a translational research career focusing on immune reconstitution after stem cell transplant and therapeutic use of adoptive cellular products. Through the CMCF and as Principal Investigator of Phase I and II clinical trials, she is working to bring cellular therapies such as chimeric antigen-receptor T cells, genetically-modified stem cells, and regulatory T-cell infusions into the clinic at Dana-Farber. Her work with the International Society of Cellular Therapy, the Foundation for the Accreditation of Cellular Therapy and the Center for International Blood & Marrow Transplant Research have promoted education and set standards for safe implementation of new approaches within the broader and ever-growing cellular therapy field.

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David Stroncek, MD
Chief, Cell Processing Section
National Institutes of Health
United States


David Stroncek the Director of the Center for Cellular Engineering (CCE) at the NIH Clinical Center. The CCE is a comprehensive facility that develops and manufactures a wide range of cell and gene therapies for phase 1 and 2 clinical trials. The CCE is currently manufacturing CAR T-cells, TCR-engineered T-cells, cancer vaccines, induced pluripotent stem cells (iPSC), retinal pigmented epithelial cells derived from autologous iPSC and genetically modified hematopoietic stems cells. In the past, the CCE has manufactured dendritic cells, NK cells, virus specific T-cells and bone marrow stromal cells. The CCE also processes hematopoietic stem cells for transplantation.

He received a Bachelor of Science degree in Chemical Engineering and a Medical Degree from the University of Minnesota. He completed residency training in Internal Medicine and fellowship training in Hematology and Oncology at the University of Minnesota.


Jay Tanna, MS, RAC
Quality Assurance Manager
Cellular Therapy Laboratory
Children's National Hospital
United States


Short Bio forthcoming.