Document is current

Article History

Received: 6 May 2026

Accepted: 29 June 2026

First Online: 8 July 2026

Declarations

:

: This study was conducted in accordance with applicable institutional, national, and international guidelines for Good Manufacturing Practice (GMP), Advanced Therapy Medicinal Products (ATMPs), and biosafety regulations. The GMP manufacturing platform, including lentiviral vector production and associated quality control procedures, was established under the regulatory oversight and certification of the Spanish Agency of Medicines and Medical Devices (AEMPS). All activities involving genetically modified organisms were performed under the corresponding authorizations from the competent Spanish authorities. As this work focused on process development, manufacturing validation, and quality control platform implementation, no direct human participant enrolment was involved in the present study. Clinical application of the resulting CAR T-cell product (CARTemis-1) is conducted separately approved clinical trial protocols in accordance with relevant ethical and regulatory approvals.

: all authors consent for publication.

: J.A-P-S serves as an advisor or consultant for Novartis, Janssen, Roche, Jazz Pharmaceuticals, Amgen, and Gilead Sciences; has received research funding from Novartis, Janssen, Pfizer, Roche, and Takeda; has received travel support from Roche, Gilead Sciences, and Janssen; and holds patents, royalties, or other intellectual property with Entourage Bioscience related to cannabinoid derivatives. E.G-G has acted as a consultant for Cellgene and GLS, and received travel grants and/or speaker fees from Cellgene, Amgen, and Janssen. E.G-G is also a co-inventor on a patent application filed by the University of Würzburg, Germany, and licensed to T-CURX GmbH, Germany, (WO2021/209498 A1).