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Off-the-shelf validated software aims to optimize clinical manufacturing processes for cell therapy manufacturing workflows.
January 17, 2024
By: Kristin Brooks
Managing Editor, Contract Pharma
Thermo Fisher Scientific has launched the Gibco Cell Therapy Systems (CTS) Cellmation Software, an automation solution designed to connect and integrate workflows across multiple Thermo Fisher Scientific cell therapy instruments while enabling cGMP compliance. This new offering aims to help eliminate the need for costly custom software projects and extensive validation during the cell therapy manufacturing process. The cell therapy manufacturing process is estimated to include upwards of 40 manual touchpoints, increasing opportunities for errors and contamination that can lead to failures and delays. The CTS Cellmation Software, powered by Emerson’s DeltaV Distributed Control System (DCS), connects Thermo Fisher’s cell therapy instruments within a single interface, reducing the number of manual touchpoints required. By establishing an automated workflow across multiple stages of cell therapy manufacturing, CTS Cellmation Software aims to help enable traceability, repeatability and 21 CFR Part 11 compliance with secured data connectivity. “As our biopharma partners continue to expand their cell therapy pipelines, CTS Cellmation Software enables digital integration of unit operations, helping to ensure reproducibility, traceability, and data security required for scaling cGMP manufacturing processes,” said Betty Woo, vice president of cell, gene and advanced therapies at Thermo Fisher Scientific. “This new software offers a fully validated, off-the-shelf automated solution to digitally connect and control Thermo Fisher fit-for-purpose instruments, ultimately helping deliver these potentially transformative medicines to patients more efficiently.”
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