Implementing LIMS in a GMP Cellular Therapy Manufacturing Facility—Dana-Farber Cancer Institute’s Experience with L7|ESP™

by L7 Informatics | posted on November 27, 2023

Over the past year, Dana-Farber Cancer Institute’s Connell and O’Reilly Families Cell Manipulation Core Facility (DFCI CMCF) has been working to implement a LIMS (Laboratory Information Management System) for their GMP cellular therapy manufacturing facility. In this blog post, we’ll take you through their challenges before implementation, their experience with L7|ESP, and the benefits they’ve realized.

A Visionary Leap

Dana-Farber Cancer Institute, renowned for pioneering cancer research and treatment work, embarked on a visionary quest to enhance its cellular therapy manufacturing facility. The objective was clear: to refine their operations, ensuring superior quality products for standard patient care and cutting-edge research. This facility operates as a Contract Development and Manufacturing Organization (CDMO), catering to various stakeholders, including Dana-Farber itself, Harvard Cancer Care, and external companies.

To appreciate the magnitude of Dana-Farber’s operations, one must look into the complexity of their organizational framework. The facility comprises various dedicated teams, each specializing in critical aspects of the manufacturing process. These include process development, a tissue bank, standard care, novel cell therapy production, testing labs, quality assurance, materials management, information management, and business direction. This comprehensive structure empowers them to efficiently handle consumable intake and the production of cellular therapy products.

At the heart of their operations lies the clinical-based activity. Dana-Farber’s facility is the epicenter for receiving, manufacturing, and banking products for research and clinical use, conducting quality control assessments, and delivering products to Dana-Farber/Harvard Cancer Center hospitals and other external institutions. 

Transitioning from Paper Records

One of the significant challenges the facility faced was the extensive use of paper records for their manufacturing processes. Looking daily at their wall of binders filled with records, the team realized the urgency of embracing a digital solution. It was evident that a transition was necessary, one that would streamline operations, fortify traceability, and minimize paper usage.

The implementation of L7|ESP was not just a small step; it was a major leap forward. Dana-Farber approached it with a phased strategy. Phase 1A marked a significant milestone, with the entire compendium being transferred to the new system. This phase was critical for discontinuing the use of legacy LIMS (Sunquest Enterprise) and gaining more control over their LIMS.

L7|ESP: A Fully Validated System

Dana-Farber’s facility went live with a fully validated system during Phase 1B and remains committed to continuous validation for each subsequent phase. This dedication to GXP compliance underpins L7|ESP’s reliability and adherence to stringent regulatory standards.

One of the highlights of their LIMS implementation was the creation of the ordering applet. This innovative feature simplifies the process of requesting tests, creating a user-friendly experience. Instead of sifting through standard operating procedures (SOPs) and work instructions, end-users can now effortlessly select tests based on the samples they are processing. This streamlined approach has markedly enhanced end-user satisfaction.

Another popular feature among the L7|ESP users, who deal daily with intricate workflow chains, notably in the context of flow cytometry, is the “flex view” for result selection. This feature empowers users to view and choose data from different runs seamlessly, significantly enhancing operational efficiency.

Realizing the Benefits and Looking Ahead

The Dana-Farber Cancer Institute’s Cell Manipulation Core Facility’s journey to implement L7|ESP has been an inspiring endeavor. The transition from paper records to a digital LIMS system has brought numerous advantages, including reducing paper usage, improving end-user satisfaction, streamlining their testing and manufacturing processes, and improving their overall efficiency and traceability. The commitment to validation and future phases demonstrates their dedication to continually enhancing their operations. With this enhancement, DFCI CMCF is also receiving training to enable them to add their content moving forward. Additionally, the facility is now gearing up to implement the L7 Manufacturing Execution System (MES) app to offer a holistic approach to operations.

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