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Resilience serves global customers across the U.S. and Canada, offering support in the development and manufacturing of drug substances and products. With a sustainable network of high-tech end-to-end manufacturing facilities supported by a team with decades of experience, Resilience is dedicated to providing solutions to help ensure the treatments of today and tomorrow can be made quickly, safely, and at scale.

Digital Transformation of Paper Processes

As a leader in biopharmaceutical manufacturing, Resilience needed to convert their paper-based Production Data and Process Records (PDPRs) into a digital system. Before adopting Sepasoft® MES, they were constrained by manual data collection and management processes, which slowed data collection and hindered timely decision-making due to the lack of real-time analysis. Additionally, these manual methods were more error-prone and failed to capture the valuable context necessary to maintain data integrity. Although most processes had already been modernized, this area required improvement—especially when it came to transferring technologies, scaling operations, and complying with FDA regulations.

To digitize processes at their Alachua, Florida, facility, Resilience implemented Sepasoft’s Batch Procedure module, leveraging its native integration with the Ignition® platform by Inductive Automation. Once Ignition was configured to capture machine data in real time, Resilience used Sepasoft’s solution to build, test, and deploy digital recipes within a month. By building recipes in a modular and standardized format, the company was able to scale operations quickly and implement repeatable unit processes.

In addition to streamlining recipe management and workflows, this automation strengthened compliance with 21 CFR Part 11 regulations by automatically tracking user actions and critical batch parameters such as cell density, viability, and media composition. This not only ensures data integrity for regulatory requirements but also provides contextualized information that is instantly available for real-time analysis and reporting. As a result, Resilience can accelerate tech transfer and make faster, more informed decisions across their network.

“While most of our processes are modernized, this process was previously entirely on paper. Data lacked contextualization and required manual data analysis to reach decisions. Using the Sepasoft [Batch Procedure] module, we aim to minimize the time invested in tech transfer.”
―Ron Sherrod, Senior Automation Engineer

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Key Benefits Achieved Through Implementation of the Batch Procedure Module

By implementing the Sepasoft Batch Procedure module and Ignition platform, Resilience achieved significant improvements, including:

• Digital Transformation of Records: Transitioning from paper-based processes to electronic Production Data and Process Records (e-PDPRs) has streamlined data recording and acquisition, allowing for more accurate and efficient data management.
• Enhanced Data Contextualization: The Batch Procedure module automates the collection and organization of critical data, such as viability and cell density. This automation ensures that data is promptly contextualized and ready for analysis, reducing the time previously spent manually compiling information.
• Improved Decision-Making: By having data automatically collated and accessible, Resilience can make informed decisions more swiftly, enhancing overall responsiveness to client needs across various stages of data collection and contextualization.
• Increased Compliance and Traceability: The e-PDPRs enhance compliance with FDA regulations like 21 CFR Part 11, as they automatically track user actions and timestamps, providing a reliable audit trail.
• Faster Tech Transfer: The capability to build and replicate digital recipes across manufacturing processes accelerates tech transfer, allowing for quicker scaling and standardization of operations.

The flexibility and integration capabilities of the Sepasoft Batch module, combined with the power of Ignition, enabled Resilience to overcome significant operational challenges. The result is a faster, more reliable, and scalable production process that supports the development and manufacture of life-saving therapies across Resilience’s growing global network.

“Building the recipes using Sepasoft allows us to do it in both a modular and standardized format, which has allowed us to scale quickly and use repeatable unit operations.”
―Miles Minvielle, Biomanufacturing Data Management Lead

Resilience Batch Procedure Case Study Transcript

Miles Minvielle (0:11):
Founded in 2020, we [Resilience] serve(s) global customers across our network in the United States and Canada. With a sustainable network of high-tech end-to-end manufacturing facilities supported by a team with decades of experience, Resilience is dedicated to providing solutions to help ensure the treatments of today and tomorrow can be made quickly, safely, and at scale.

Ron Sherrod (0:36):
Resilience offers several ways to engage: incubation, collaboration, and manufacturing to support the development of 70 molecules across our portfolio. With more than 50 active customers ranging from large to small pharma and biotechs as well as government and NGOs, Resilience offers manufacturing and development for drug substance and drug product, working across all stages of five primary modalities: biologics, vaccines, nucleic acids, cell therapy, and gene therapy.

Miles Minvielle (1:05):
The Ignition platform was already a corporate standard due to its flexibility and easy integration with both manufacturing equipment and other software systems. As a manufacturing execution system built on Ignition, Sepasoft offers a plug-and-play alternative to other systems. Our facility in Alachua, Florida leverages the Sepasoft Batch module in production, and we are working to expand the capabilities across the network. Once Ignition was configured to sync with our manufacturing equipment, building, testing, and deploying recipes in Sepasoft took about a month.

Arthur Rudolph (1:43):
The batch recipe guides and records the materials and equipment that we’re using in an upstream bioreactor run, as well as all the data that we record like viability, cell density, and various chemical parameters of the media throughout the rest of our runs. A large challenge we faced when we were getting started with this was translating our paper Production Data and Process Records (PDPRs) into the digital format and accurately capturing all the steps and data that we would typically record on paper.

Ron Sherrod (2:12):
While most of our processes are modernized, this process was previously entirely on paper. Data lacked contextualization and required manual data analysis to reach decisions. Using the Sepasoft [Batch Procedure] module, we aimed to minimize the time invested in tech transfer. Processes that were highlighted were common across all of Resilience, such as bioreactor operations. This will improve our ability to execute more swiftly for our client at each stage.

Arthur Rudolph (2:38):
The flexibility of Ignition and Sepasoft let us translate these paper records into our e-PDPRs which then sped up our data recording and acquisition, and let us more quickly translate the data that we record during a run into actionable information. Two of the best things about using the e-PDPRs were improved 21 CFR compliance and improved data management and allowing us to have automated data reporting. The e-PDPR automatically tracks the user and the actions they take and when they take them, meaning we automatically have a record of all of those things. For the automated data flows, on the paper records it takes days or weeks to compile all the individual data points before you can even begin to perform an analysis and make decisions based off of that data. With the e-PDPR, all of that data is automatically contextualized, collated, and ready for querying so that we can pull it out into an automatic report that we’ve previously generated.

Miles Minvielle (3:45):
Sepasoft allows us to build a digital construct of recipes. Using both Sepasoft and Ignition in the development and manufacturing spaces allows us to copy/paste recipes across them, speeding up and simplifying tech transfer. Building the recipes using Sepasoft allows us to do it in both a modular and standardized format, which has allowed us to scale quickly and use repeatable unit operations.