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

Author:

Melocchi AliceORCID,Schmittlein Brigitte,Jones Alexis L.,Ainane Yasmine,Rizvi Ali,Chan Darius,Dickey Elaine,Pool Kelsey,Harsono Kenny,Szymkiewicz Dorothy,Scarfogliero Umberto,Bhatia Varun,Sivanantham Amlesh,Kreciglowa Nadia,Hunter Allison,Gomez Miguel,Tanner Adrian,Uboldi Marco,Batish Arpit,Balcerek Joanna,Kutova-Stoilova Mariella,Paruthiyil Sreenivasan,Acevedo Luis A.,Stadnitskiy Rachel,Carmichael Sabrina,Aulbach Holger,Hewitt Matthew,De Mollerat Du Jeu Xavier,Robilant Benedetta di,Parietti Federico,Esensten Jonathan H.

Abstract

AbstractThe 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. Here, 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 activating and expanding human CD8+ T cells. The robotic cultures showed comparable cell yields, viability, and identity to those manually performed. 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.

Publisher

Cold Spring Harbor Laboratory

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