Book Review: Getting Started in Processing for Biotherapies

AABB’s recently published book, Getting Started in Processing for Biotherapies, outlines the major processes to consider in planning for a new or expanded biotherapies processing laboratory and shares how to bring plans from conception to reality. This essential resource, released in late 2024, is intended to assist facilities and professionals at the beginning of a journey, covering foundational concepts and requirements and offering options to consider before acting.

Specific topics include the type of work to be performed; quality management aspects; regulatory oversight; often overlooked support and ancillary services; and the very critical choices involving space, equipment, supplies and staffing. The narrative, illustrations, references for further study and helpful tools in the appendices are all designed to help readers get a solid start in the process of planning for a new program launch. Written by experts, the content includes helpful tips, tools and templates that can help clarify the benefits and challenges of the endeavor.

Carmen Iancu-Rubin, PhD, CABP, professor in the Department of Pathology, Molecular and Cell-Based Medicine at Icahn School of Medicine in New York, provided a review of the publication below:

The last decade has witnessed an exponential growth in the field of cell and gene therapy. Traditional Cellular Therapy Laboratories (CTLs) that have been handling minimally manipulated products for stem cell transplantation have taken on additional functions to accommodate the advent of novel cell-based therapies. These new functions have triggered the implementation of new processes, acquisition of specialized equipment, targeted training for personnel and in some cases, establishing entirely new facilities. In this context, publication of Getting Started in Processing for Biotherapies by AABB is timely and extremely relevant resource for any organization poised to expand or build an in-house cellular therapy laboratory.

The book is elegantly structured to guide both planning and infrastructure development for biotherapies processing for stem cell transplantation and cellular immunotherapy programs. The authors convey in a clear yet comprehensive manner key considerations for establishing or expanding a cellular therapy laboratory, ranging from financial planning and staffing to process implementation, quality assurance and regulatory compliance. Each chapter emphasizes the importance of a stepwise, interdisciplinary approach to each of the aspects discussed with clear illustrations and examples. Furthermore, each chapter is referenced throughout, thus proving the reader with an easy to follow ‘how-to’ guide and its procedural and regulatory ramifications.

This important new AABB resource provides a solid foundation for planning, developing and implementing the processes and methodologies for establishing a cellular therapy laboratory that ensures the highest standards of safety and efficacy.