Standard Operating Procedures for eCTD Lifecycle Management in Autologous CAR T Cell Therapy Programs: Chain of Identity as the Organizing Principle
Year: 2026
Type: article
Abstract: A Standard Operating Procedure for eCTD compilation, publishing, and submission is, for most product categories, a document-management and project-management artifact: it describes how source documents move from functional teams into Module 1 through Module 5, how quality control is performed, and how the final sequence is validated and transmitted. For an autologous chimeric antigen receptor (CAR) T cell program, this framing is necessary but not sufficient. An autologous CAR T product is manufactured from a specific patient's own T cells, collected by leukapheresis, genetically modified ex vivo, expanded, and returned to that same patient; the product literally cannot exist, and cannot be administered, independent of a single named individual (U.S. Food and Drug Administration, 2024a). An eCTD SOP for this category must therefore be built around a requirement that barely registers in a conventional small-molecule SOP: maintaining an unbroken, verifiable chain of identity (COI) linking a specific patient to a specific manufacturing batch, from collection through infusion, with the regulatory documentation of that chain forming a genuinely distinct content stream within the submission.
Author: Pirouzi, Peivand
Institution: Seneca Polytechnic
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225108430