On December 15, 2021 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that its LyFE Manufacturing Center in Bothell, Washington has been commissioned and qualified in compliance with the U.S. Food and Drug Administration’s (FDA’s) Current Good Manufacturing Practices (cGMP) (Press release, Lyell Immunopharma, DEC 15, 2021, View Source [SID1234609995]).
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The cGMP qualification confirms Lyell has the proper design, monitoring and control of its manufacturing facility. Since becoming operational in April 2021, the LyFE Center has completed successful engineering runs at scale in support of the Company’s planned upcoming clinical trials.
"We are advantageously positioned with qualified manufacturing infrastructure that we own and control to support consistent and reliable manufacture of cell products for our upcoming clinical trials," said Liz Homans, Chief Executive Officer of Lyell. "We believe that combining cGMP manufacturing with our deep understanding of T-cell biology will help us achieve our vision of curing patients with solid tumors."
With 70,000 square feet of space, the LyFE Manufacturing Center provides several key capabilities for cell therapy manufacturing. The facility utilizes electronic systems with advanced data and analytics for real-time feedback, batch monitoring and process optimization. To support its digital manufacturing capabilities, Lyell collaborates with Amazon Web Services (AWS). The LyFE Manufacturing Center is one of the first cell therapy manufacturing facilities to benefit from AWS’s extensive experience with cloud computing, Internet of Things (IoT) and advanced analytics.
"Lyell is dedicated to developing safe and effective cell therapies for patients by investing in innovative operations and technology, including our LyFE Manufacturing Center that is designed to support a broad pipeline and is now qualified to support cGMP manufacturing standards," said Stephen Hill, Chief Operating Officer of Lyell. "Integrating digital systems into our manufacturing operations means quicker access to data, leading to faster recognition and implementation of process improvements."