BUNDLE: Standards for Cellular Therapy Services, 12th edition – Print and Guidance

This bundle consists of Standards for Cellular Therapy Services, 12th edition, and Guidance for Standards for Cellular Therapy Services, 12th edition.

Standards for Cellular Therapy Services (CT Standards), effective July 1, 2025, sets forth the latest standards of practice for accredited cellular therapy facilities through quality as well as technical standards. It includes overarching quality standards as well as specific technical standards.

Significant Changes to the 12th Edition

• Accredited programs must contact AABB if something has occurred that affects their accreditation status if they are under investigation by their relevant Competent Authority.
• Accredited programs must monitor their critical technology infrastructure and show things function as expected.
• Accredited programs must have processes for the quarantine and disposition of critical supplies and materials.
• When products are returned, accredited programs must identify the products and follow the requirements in 5.22.4 before any potential reissue.

Guidance for Standards for Cellular Therapy Services includes verbatim requirements from the CT Standards interspersed with guidance. Language from the CT Standards is presented; when there is appropriate guidance for that standard, the guidance language follows the standard with the heading “Guidance.” This format allows the reader to see both the requirement and the associated guidance side by side.

Please note that there is no guidance for some standards. The Cellular Therapy Standards Program Commit¬tee has chosen to focus Guidance for Standards for Cellular Therapy Services on those issues that may require additional context and/or examples to assist in attaining compliance with the Standards.

Effective date: July 1, 2025

PRINT EDITION: AABB, 2025, 254 pages, ISBN 978-1-56395-523-5 and 2025, AABB, softcover, 158 pages
Product Code: 253099
Member Price: $334
Nonmember Price: $484

Item Details (Print):

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)

Item Details (Guidance):

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)