National Survey of FACT-Accredited Cell Processing Facilities: Assessing Preparedness for Local Manufacturing of Immune Effector Cells

Magdi Elsallab; Florence Bourgeois; Marcela V Maus

doi:10.1016/j.jtct.2024.03.016

National Survey of FACT-Accredited Cell Processing Facilities: Assessing Preparedness for Local Manufacturing of Immune Effector Cells

Transplant Cell Ther. 2024 Mar 16:S2666-6367(24)00289-6. doi: 10.1016/j.jtct.2024.03.016. Online ahead of print.

Authors

Magdi Elsallab¹, Florence Bourgeois², Marcela V Maus³

Affiliations

¹ Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts; Cellular Immunotherapy Program, Cancer Center, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
² Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.
³ Cellular Immunotherapy Program, Cancer Center, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Cancer Center, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: MVMAUS@mgh.harvard.edu.

PMID: 38494077
DOI: 10.1016/j.jtct.2024.03.016

Abstract

The utilization of the human immune system as a therapeutic modality has materialized in the form of novel biologics known as immune effector cells (IECs). However, currently approved IECs rely on autologous cells for manufacturing that are funneled through costly centralized supply chains leading to long wait times and potentially increased mortality. Alternative models for manufacturing at or near the point-of-care in a distributed and local approach are being proposed to overcome such a bottleneck. Cell processing facilities for minimally manipulated products, as well as academic good manufacturing practice facilities, are being considered for such manufacturing tasks. However, the infrastructure and the practices of these facilities remains unstudied. Here, we surveyed the cell processing facilities accredited by the Foundation for Accreditation of Cellular Therapy (FACT) in the United States to better understand their preparedness for local manufacturing of IECs. A structured survey consisting of 40 items was distributed to the directors of 157 facilities. The survey evaluated 6 domains, including facility characteristics, quality practices, personnel, use of automation, experience with IECs, and the perception of the point-of-care model. Thirty-eight facilities completed the survey (24.2%). Most facilities were involved in handling IEC products (35/38, 92.1%), and the majority had infrastructure to support basic operations and quality control such as viability (36/36, 100%), identity (33/36, 91.7%), and sterility (33/36, 91.7%). The quality practices varied among the facilities depending on the types of products processed. A slight majority implemented automation in their workflows (22/38, 57.9%). Facilities expressed a general interest in adopting point-of-care models (23/38, 61%), with financial and human resources identified as the most significant constraints. In conclusion, FACT-accredited cell processing facilities may provide the infrastructure required for local manufacturing. However, there is a need for standardization and minimum quality requirements to effectively implement such models.

Keywords: CAR T cells; Cellular immunotherapy; Decentralized; Distributed; Food and Drug Administration; Immune effector cells; Manufacturing; Point-of-care.