Made Scientific and Streamline Bio have completed initial validation of Streamline Bio’s AI-driven precision robotics platform in a live cell therapy production environment. The validation took place at Made Scientific’s facility in Princeton, NJ.
Following this validation, the companies are moving towards Good Manufacturing Practice (GMP) integration, including early-adopter programs and deploying the fully robotic manufacturing solution for cell therapy developers. Streamline Bio’s platform is designed to address common challenges in the cell and gene therapy (CGT) sector such as manufacturing complexity, high costs, and variability in product quality.
According to the companies, the AI-driven platform is built to be flexible and adaptable across various equipment and protocols, aiming to limit the need for process changes or custom configurations. The technology automates manual, labor-intensive steps, which the companies say can reduce operator burden, lower risks of human error, reduce costs, enable skilled staff to focus on higher-value activities, and ensure full data traceability through its digital-first design.
The next phase includes preparing the platform for GMP deployment with equipment including Miltenyi CliniMACS Prodigy®, G-Rex®, and Fresenius-Kabi LOVO® systems. The validated platform will be integrated into Made Scientific’s GMP cleanrooms to demonstrate orchestration of complex, multi-step workflows for potential commercial-scale use. Upcoming studies will further evaluate automated analytical and quality control testing workflows.
“Today’s CGT processes are incredibly nuanced and complex,” said Rodney Rietze, Ph.D., President & CEO of Streamline Bio. “Streamline Bio’s robotic platform allows cell and gene therapy developers and manufacturers to respond with automation that’s not only smart and scalable, but inherently adaptive – enabling it to seamlessly integrate into your existing infrastructure with minimal costs and no workflow restrictions.”
“Streamline Bio is redefining manufacturing by offering an innovative, flexible and scalable platform aimed at making transformative therapies more accessible to patients,” said Syed T. Husain, Chairman & CEO of Made Scientific. “We’re excited to partner together as the companies explore how their technology can ultimately impact cost, process and product reproducibility, and time-to-clinic for emerging therapies.”
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