Cell Therapy Protocols

TOPICAL COLLECTIONS

Guest Editor

Alexey Bersenev

Yale University

Dr. Alexey Bersenev received his medical education and certification as a general surgeon in Russia. He holds a PhD in transplantation/ pathology. He gained expertise in immunology, hematology, stem cell biology and published scientific papers during post-doctoral training in the US in Philadelphia at the Thomas Jefferson University and the Children’s Hospital of Philadelphia. He worked as a cell manufacturing specialist at the University of Pennsylvania and trained in clinical cell processing in a GMP cell manufacturing facility and was involved in the manufacture of CAR T-cell products for clinical trials and technology transfer to industry. He has expertise in clinical manufacturing of cellular products for clinical trials, including product and process development, cell processing and culture, operations of academic GMP facility and compliance with regulations. In addition to his position as Director of the Advanced Cell Therapy Lab at Yale-New Haven Hospital, he is an Assistant Professor of Clinical Laboratory Medicine at the Department of Laboratory Medicine at Yale University.

Collection Overview

The aim of this collection is to demonstrate some common techniques and equipment, used in the facilities, involved in manufacturing of cell- and cell-gene therapy products for clinical trials. This is an exciting and growing area of modern biomedicine. A recent massive commercialization of the field is fueled by a great academic interest in early development of cell-/cell-gene product manufacturing techniques. Cell therapy manufacturing techniques may include, but not limited to tissue dissociation, cell selection/sorting, cell culture - expansion ex vivo, gene transfer via transduction/transfection, cell wash and cryopreservation.