GENEX: Robotic Gloveless Isolator System for Next-Generation Cell and Gene Therapies
Scaling cell and gene therapy manufacturing is still limited by manual operations, contamination risks and complex regulations.
GENEX by Bausch+Ströbel introduces a robotic gloveless isolator platform designed to meet EU GMP Annex 1 standards while enabling matrix production. Matrix manufacturing represents a new paradigm for sterile drug production, replacing linear, single-line workflows with a flexible grid of modular units. By enabling concurrent, independent processes under harmonized environmental controls, it reduces downtime, enhances capacity, and supports rapid scale-up of advanced therapies.
Furthermore, the session will show how advanced robotics, automated environmental monitoring and integrated in-process controls reduce human intervention and variability. Regulatory insights will concentrate on Annex 1 contamination control strategies and validation requirements, emphasizing the ways in which GENEX integrates robust automation and segregation to support operational efficiency and compliance.
Attendees will gain practical strategies for integrating cutting-edge robotic technology with a novel drug product matrix manufacturing approach to expedite the time to market and enhance patient access to advanced therapies in the C> sector.
