In 2014, executive leadership at AABB and ISCT agreed to establish a joint working group (WG) for the purpose of identifying issues common to both organizations in the cellular therapy (CT) arena and exploring advocacy issues on which both organizations can collaborate. The WG has been involved in several projects since then. This session will provide updates on two of the current projects executed by two teams of experts recruited through the WG.

Project 1: Considerations for the Establishment of a CT Product Stability Program

The goals of the project are to:

educate the community regarding considerations for CT stability programs

create reference documents/communication materials to help with the design of a stability program for hematopoietic stem/progenitor cell products

Project 2: Establishment of a GTP interpretative tool that can assist with clarification of Human Cells, Tissues and Cellular-Based Products (HCT/Ps) regulations under 21 CFR 1271 and Section 361 of the PHS Act and/or the FD&C Act

The goals of this project are to:

educate community regarding interpretation of GTP requirements and how best to prepare for FDA inspections of establishments that manufacture HCT/Ps

create a tool providing section-by-section guidance specific to the needs of a CT laboratory to achieve regulatory compliance and preparation for unannounced FDA inspections

To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.

Nadim Mahmud MD, PhD

University of Illinois College of Medicine

Appearances