News Hub

The AABB/ISCT GTP Interpretative Tool Project


A New Collaborative Effort to Facilitate Regulatory Compliance

F. Enrique Alvarez
Assistant Director,  Quality Assurance and Regulatory Compliance, Cell Therapy Laboratory
M D Anderson Cancer Center
Houston, Texas, USA

J. Wade Atkins
Supervisor, Quality Assurance and Regulatory Affairs
National Institutes of Health
Bethesda, Maryland, USA

Coming in late January 2023, a new offering will be available to enhance our membership’s understanding of regulatory requirements for cell therapy programs.  The AABB/ISCT GTP Interpretative Tool, a project commissioned by the AABB-ISCT Joint Working Group, is meant to provide a section-by-section guidance that is specific to the needs of a cell therapy program in order to achieve regulatory compliance and preparation for unannounced FDA inspections. The tool will be added to the websites of both AABB and ISCT for access by active members.

The creation of the new AABB/ISCT GTP Interpretative Tool is the work of a multidisciplinary team that included AABB and ISCT representatives.  The team had a well-balanced combination of talent including academia, product development, manufacturing, industry and regulatory expertise.  The project, which started in September 2020, required the team of eight (8) to meet virtually for the next 23 months through the COVID pandemic.  Throughout the process, the team’s discussions were lively, inquisitive, informative and entertaining, as they learned from each other’s experiences while creating a user-friendly, non-prescriptive document.

The goal of the AABB/ISCT GTP Interpretative Tool is to educate the cell therapy community regarding interpretation of GTP requirements and how best to prepare for FDA inspections of establishments that manufactures HCT/P's.  The purpose of the document is to consolidate references and provide direct access and links that aid in the determination of the correct regulatory pathways for 361-based products during both early and late-stage development, excluding reproductive applications.  It includes references to scientific literature and other relevant documents for individuals interested in additional information. Links and references will be reviewed periodically and updated accordingly.

The AABB/ISCT GTP Interpretative Tool, which is provided in a simple four-column format (see below), includes an overview of HCT/P regulations under 21 CFR 1271 and Section 361 of the PHS Act and/or the FD&C Act, clarification of required regulations for HCT/Ps, and explanation and expectations for each section/subsection in Part 1271 regulations and Section 361 of the PHS Act.  The active hyperlinks will take the reader directly to the source documentation for ease of finding these references.

The document incorporates an introduction to the use of the tool, a list of abbreviations used throughout the content, and a tabular format including the individual GTP Regulation (link), GTP GTP Guidance References (link), GTP Considerations which simplify the regulation content, and an Additional Resources section that contains useful information related to the subject of the regulation.


We hope this new addition to the “tool belt” of our membership becomes a practical instrument that meets their needs, clarifies intricate concepts and helps in the preparation of regulatory submissions.

This is intended to be a “living document” with periodic updates as new information from the FDA or other valid sources becomes available.  The AABB-ISCT Joint Working Group is actively seeking interested members that may want to serve on the team for reviews and updates.

The AABB-ISCT Joint Working Group was formed in January 2015 as a collaborative effort to identify and facilitate projects of common interest to both organizations and their significant overlap of members.  The GTP Interpretative Tool Project was chartered in 2020, with representation of members from both organizations.