Development of a robotic cluster for automated and scalable cell therapy manufacturing.

Autor: Melocchi A; Multiply Labs, San Francisco, California, USA; Sezione di Tecnologia e Legislazione Farmaceutiche 'M. E. Sangalli', Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Milano, Italy. Electronic address: alice.melocchi@unimi.it., Schmittlein B; Multiply Labs, San Francisco, California, USA., Jones AL; Multiply Labs, San Francisco, California, USA; Department of Health Sciences and Technology, Harvard-Massachusetts Institute of Technology, Cambridge, Massachusetts, USA., Ainane Y; Multiply Labs, San Francisco, California, USA., Rizvi A; Multiply Labs, San Francisco, California, USA., Chan D; Multiply Labs, San Francisco, California, USA., Dickey E; Multiply Labs, San Francisco, California, USA., Pool K; Multiply Labs, San Francisco, California, USA., Harsono K; Multiply Labs, San Francisco, California, USA., Szymkiewicz D; Multiply Labs, San Francisco, California, USA., Scarfogliero U; Multiply Labs, San Francisco, California, USA., Bhatia V; Multiply Labs, San Francisco, California, USA., Sivanantham A; Multiply Labs, San Francisco, California, USA., Kreciglowa N; Multiply Labs, San Francisco, California, USA., Hunter A; Multiply Labs, San Francisco, California, USA., Gomez M; Multiply Labs, San Francisco, California, USA., Tanner A; Multiply Labs, San Francisco, California, USA., Uboldi M; Multiply Labs, San Francisco, California, USA; Sezione di Tecnologia e Legislazione Farmaceutiche 'M. E. Sangalli', Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Milano, Italy., Batish A; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA., Balcerek J; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA., Kutova-Stoilova M; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA., Paruthiyil S; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA., Acevedo LA; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA., Stadnitskiy R; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA., Carmichael S; Cytiva Life Sciences, Marlborough, Massachusetts, USA., Aulbach H; Thermo Fisher Scientific, Langenselbold, Germany., Hewitt M; Charles River Scientific, Wilmington, Massachusetts, USA., Jeu XMD; Thermo Fisher Scientific, Carlsbad, California, USA., Robilant BD; Dorian Therapeutics, San Francisco, California, USA., Parietti F; Multiply Labs, San Francisco, California, USA., Esensten JH; Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA; The Advanced Biotherapy Center (ABC), Sheba Medical Center, Tel Hashomer, Israel.
Jazyk: angličtina
Zdroj: Cytotherapy [Cytotherapy] 2024 Sep; Vol. 26 (9), pp. 1095-1104. Date of Electronic Publication: 2024 Mar 15.
DOI: 10.1016/j.jcyt.2024.03.010
Abstrakt: Background Aims: The production of commercial autologous cell therapies such as chimeric antigen receptor T cells requires complex manual manufacturing processes. Skilled labor costs and challenges in manufacturing scale-out have contributed to high prices for these products.
Methods: We present a robotic system that uses industry-standard cell therapy manufacturing equipment to automate the steps involved in cell therapy manufacturing. The robotic cluster consists of a robotic arm and customized modules, allowing the robot to manipulate a variety of standard cell therapy instruments and materials such as incubators, bioreactors, and reagent bags. This system enables existing manual manufacturing processes to be rapidly adapted to robotic manufacturing, without having to adopt a completely new technology platform. Proof-of-concept for the robotic cluster's expansion module was demonstrated by expanding human CD8+ T cells.
Results: The robotic cultures showed comparable cell yields, viability, and identity to those manually performed. In addition, the robotic system was able to maintain culture sterility.
Conclusions: Such modular robotic solutions may support scale-up and scale-out of cell therapies that are developed using classical manual methods in academic laboratories and biotechnology companies. This approach offers a pathway for overcoming manufacturing challenges associated with manual processes, ultimately contributing to the broader accessibility and affordability for personalized immunotherapies.
Competing Interests: Declaration of competing interest BS, ALJ, YA, AR, DC, ED, KP, KH, DS, US, VB, AS, NK, AH, MG and AT, wish to disclose that they are current employees of Multiply Labs, Inc. or were employed with the company at the time of this study's execution. They hold equity in the company; AM and FP wish to disclose that they are co-founders of Multiply Labs, Inc. and hold the position of Chief Scientific Officer and Chief Executive Officer, respectively; SC wishes to disclose that she is employed by Cytiva, which is a company active in the cell therapy manufacturing space; MH wishes to disclose that he is employed by Charles River Laboratories, which is a company active in the cell therapy manufacturing space; HA and XJ wishes to disclose that they are employed by Thermo Fisher Scientific, which is a company active in the cell therapy manufacturing space; BDR is a paid advisor to Multiply Labs, Inc. and holds equity in the company; JHE is a paid advisor to and receives sponsored research funding from Multiply Labs, Inc. He serves on its scientific advisory board and holds equity in the company. He receives sponsored research funding from Lonza, Inc. for the development of cellular therapy manufacturing devices.
(Copyright © 2024 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: