Preface

The Standards Program Committee (SPC) and the Cellular Therapies Standards Committee (CT SC) are pleased to present this 12th edition of Standards for Cellular Therapy Services (CT Standards).

The SPC is the umbrella committee whose primary role is to oversee the creation, development, and revision of all AABB standards to ensure harmonization and consistency in AABB’s standard-setting activities. The SPC consists of a committee chair, the chair of the Standards Subcommittee for the Evaluation of International Variances, and the chairs of the ten standards committees.

The CT SC consists of a chair; co-chair; full members representing the cellular therapy field (including cord blood professionals, clinicians, medical and laboratory professionals, medical technologists, and quality experts); liaisons from other AABB task forces, committees, and work groups; and representatives from other organizations. The CT SC meets during the 2-year revision cycle and has frequent meetings to discuss requests for variance from each edition of CT Standards and requests for standards interpretations.

The guiding principle of this document is to be consistent with available scientific information while focusing on patient advocacy and optimal care for donors and patients. The requirements are intended to be simple, clear, and practical. The use of CT Standards should aid materially in developing and maintaining policies, processes, and procedures that will provide safe and effective procurement, storage, processing, distribution, and administration, as well as a safe work environment for cellular therapy product service personnel.

The CT SC developed this 12th edition of CT Standards using an evidence- based decision-making process, when possible, to modify existing requirements or to create new ones. The changes in this edition reflect a response to the changing scientific and/or regulatory environment. Although the CT Standards provides a great amount of technical information concerning cellular therapy activities, there are other AABB publications that provide specific recommendations. When using this edition of the CT Standards, having access to the current edition of the AABB Technical Manual and the current edition of the Circular of Information for the Use of Cellular Therapy Products could be of service in understanding and implementing these requirements. Guidance for specific standards that appear in this edition of the CT Standards is published in Guidance for Standards for Cellular Therapy Services, available as part of the AABB Standards Portal and in print. The CT SC has published a document providing informal responses to the comments received during the comment period explaining why the CT SC adopted a suggestion or did not. This document can be found on the AABB website.

This 12th edition of CT Standards implements AABB’s updated quality system essentials. The quality system essentials were first introduced by AABB in Association Bulletin #97-04 and have served as the framework on which the CT Standards have been presented since 2000, when the CT Standards previously appeared as the Standards for Hematopoietic Progenitor Cells. Since the year 2000, the quality requirements in the CT Standards (and all sets of AABB Standards) have been updated on an as-needed basis, with changes occurring incrementally but not in a universally applicable fashion. This updated version of the quality system essentials has been standardized in terms of language and style and incorporated in all sets of AABB Standards as they are updated, beginning with the 16th edition of Standards for Relationship Testing Laboratories, effective January 1, 2024. The updated quality system essentials include the following updates:

All standards are written in the active voice.
Once a requirement has been stated, it is not repeated.
Each chapter begins with a description of what the standards therein cover.
Each chapter contains a list of key terms that relate to the content of the chapter, with their definitions.
Each chapter contains a list of examples of objective evidence that an assessor could look for during an on-site assessment; however, this list is not comprehensive, nor will it be assessed against by an assessor. It is merely for guidance purposes only.
Each chapter now concludes with the record retention table for that chapter. Note that a comprehensive record retention table still exists at the end of Chapter 6.

The AABB and the CT SC feel that these updates across these CT Standards (and all Standards) will provide a reset and upgrade on the previous version of the quality system essentials and will allow these CT Standards to take the next step in quality.

I would like to acknowledge and thank all the members of the CT SC. Keeping the CT Standards relevant and up to date in a field that rapidly evolves is no small endeavor. Each member brings deep subject matter expertise and consistently puts forth their best effort, volunteering their time and experience as we have delved into questions, reviewed comments, and worked towards consensus on revising or creating new standards for this 12th edition. As we concluded our inperson meeting prior to AABB’s annual meeting, we collectively acknowledged how much we each learn about different facets of cellular therapy during the 2-year revision cycle. Working in partnership with this committee has been an honor and a privilege, allowing me to gain valuable experience and broaden my understanding of the field. I would especially like to thank Dr. Kevin Land for his laughter and humor during our meetings and Dr. Wanxing Cui for introducing us to new tools while ensuring we had relevant data points from other sources during our discussions.

The work of the CT SC is a collaborative effort, and I greatly appreciate the valuable input from our liaisons at other AABB committees and representatives from other organizations. Their contributions allow us to achieve a holistic view while looking forward and anticipating emerging trends and relevant initiatives from other entities.

I also extend my appreciation to the many professionals and stakeholders who provided insightful feedback during the public comment periods. Public comment periods are invaluable. Your comments help us view proposed revisions with fresh eyes and are instrumental in refining the standards to meet the needs of our diverse and advancing field.

Lastly, I would like to express my personal gratitude to Chris Bocquet, our AABB staff liaison. It has been a pleasure to collaborate with Chris on this and other AABB initiatives. Chris is always available to offer advice specific to our CT SC as well as insights from across the AABB Standards committees to ensure that our group is successful. He provides structure and forward momentum to the committee’s work, balanced with humor and levity. It takes a special talent to encourage and shape volunteer experiences into meaningful opportunities that make a difference. Being a part of the CT SC and getting to know Chris and the other committee members with whom I have served on this and prior editions has been a truly impactful part of my professional journey.

Katherine Brown, PhD
Chair, Cellular Therapies Standards Committee