Quintessential Role Of Apheresis In Gene-Modified T-Cell Therapy

By Dalip Sethi, PhD, and Erin Goodhue, DO, MPH – Terumo Blood and Cell Technologies

The removal of white blood cells from a patient or donor is a critical step in the manufacturing of gene-modified T-cell therapies. A thorough understanding of the methods and processes involved in leukapheresis can only benefit the patients and biotech companies developing these therapies.

In recent years, cellular based therapy has been incorporated into the regulatory guidance around donor identification, collection, cell therapy manufacturing, and administration. These regulatory guidelines help establish effective standard operating procedures and quality management systems. Learn more about process standardization and comprehensive quality management programs as it related to cell therapy manufacturers.