AABB Publishes Biotherapies Manual, a New Essential Resource for the Field

AABB recently published a landmark new book for the field: the AABB Biotherapies Manual: Principles, Processes, and Practice, a first-of-its-kind reference covering practices for developing and producing cellular and biotherapy products.

The book is designed as a key new resource for the field, outlining critical information that those in the biotherapies field need to begin or advance biotherapies practices. Written and edited by experts from academia, industry and regulatory agencies, the AABB Biotherapies Manual provides information on requirements and common practices in cell processing and evaluation. It is intended to support laboratory staff in developing procedures that comply with applicable regulations and standards.

As many members of the AABB community are undoubtedly aware, AABB has published the Technical Manual (now in its 22nd edition) for many years. The Technical Manual is today known as the “bible of transfusion medicine” and is considered a must-have resource for professionals working in transfusion medicine. AABB developed the AABB Biotherapies Manual with the intention of creating a publication that would become as important for biotherapies as the Technical Manual is for transfusion medicine.

Filling a Need

In recent years, some AABB members have noted that the biotherapies side of the field was lacking a comprehensive reference book—one that detailed everything that was important for professionals working in biotherapies to know.

AABB set out to fill this need by enlisting experts in the field to help develop and write the AABB Biotherapies Manual. David McKenna, MD, CABP(H), professor of laboratory medicine and pathology at the University of Minnesota, and David Stroncek, MD, chief of the department of transfusion medicine and cellular therapies at the National Institutes of Health, were asked to serve as editors-in-chief. The additional editorial team comprised J. Wade Atkins, MS, MLS, SBB, CQA, CABP(H); Diane Kadidlo; Ellen Lazarus, MD; and Ena Wang, MS, MD.

“AABB had previously published two editions of an excellent cellular therapies text edited by Ellen Areman and Kathy Loper, but the field has expanded considerably since then and many in the field thought a new, expanded text was due,” McKenna told AABB News.

McKenna added that he expects the AABB Biotherapies Manual will be a welcome new addition to the offerings for biotherapies professionals in the AABB community. “AABB has expanded more and more into biotherapies in recent years and the AABB membership has grown to include more professionals working in cell therapy-focused settings,” he said. “Much like the Technical Manual for blood banking and transfusion medicine, we expect the AABB Biotherapies Manual to be the go-to resource for a wide range of cell and gene therapy and regenerative medicine topics.”

Covering All Aspects of the Field

The AABB Biotherapies Manual is designed to provide all necessary information in one volume. The book comprises 35 chapters and appendices, covering the critical steps, materials and equipment used in various biotherapies processes. Sections address regulatory considerations, quality oversight, processing operations, facilities and equipment, cell collection, product development and manufacturing, testing and characterization of cells, laboratory assays, and product storage, issue and infusion. The publication also includes examples and templates for laboratory document preparation and facility activities.

Much like the Technical Manual for blood banking and transfusion medicine, we expect the AABB Biotherapies Manual to be the go-to resource for a wide range of cell and gene therapy and regenerative medicine topics.” — David McKenna, MD, CABP(H)

McKenna said that considerable time was spent determining every topic that should be included in the book. “Dr. Stroncek and I brainstormed with the associate editors, other AABB members and AABB staff,” he said. “We wanted to ensure that the book included a breadth of the core topics within all areas of biotherapies—quality, regulatory, technical, medical and scientific.”

McKenna added that he expects the AABB Biotherapies Manual to be periodically updated—just as the Technical Manual has been for many years—to include new and relevant information as biotherapies continue to evolve. “As the field grows, so too will the AABB Biotherapies Manual,” McKenna said. “Future editions may have chapters on yet-to-be explored therapies, new tools for genetic modification, non-cellular delivery and other exciting developments.”

At the AABB Annual Meeting

The AABB Biotherapies Manual is available now in the AABB Store and will also be available in the AABB Bookstore during the 2026 AABB Annual Meeting in Atlanta.

In addition, McKenna and Stroncek will be signing copies of the AABB Biotherapies Manual during a special book signing event at the AABB Annual Meeting. The book signing will take place on Monday, Oct. 19, from 11 to 11:30 a.m. in the Biotherapies Pavilion. During this time, the two editors-in-chief will share brief remarks about how the book came together, its significance to the field and the many contributors who helped make the publication possible.