Customer Stories / Life Sciences
Lyell Reduces Time to Validate GxP Compliance from Weeks to Minutes Using AWS
Learn how Lyell Immunopharma automates continuous GxP compliance and deploys system changes and upgrades faster using AWS.
For Lyell Immunopharma (Lyell), an immuno-oncology company with a mission to cure solid tumor cancers, it is critical to validate the systems and applications for its T-cell reprogramming workflows to comply with US Food and Drug Administration (FDA) regulations. Previously, these validations were done manually, which was expensive, time-consuming, and prone to potential errors. To facilitate compliance and meet the FDA’s computer software assurance (CSA) guidelines, Lyell needed a more efficient validation process.
Lyell turned to Amazon Web Services (AWS) and built Rapid Q, a solution that automatically validates FDA compliance and documents changes made to an environment or application. Now, the company can validate compliance in minutes instead of weeks and deploy new updates and systems at a faster pace.
Opportunity | Reducing the Time to Validate GxP Compliance from Weeks to Minutes
With a mission to use autologous cell therapy to cure solid-tumor cancer, Lyell uses reprogrammed T cells to develop potential new therapies. Once extracted, these T cells are processed at Lyell’s manufacturing facility and then infused back into the patient. To mitigate process deviations that could lead to negative patient outcomes, it is critical to validate the environment in which all the manufacturing systems are running. The data generated by the system also needs to have robust integrity and accuracy so that it can be used for analytics downstream. However, Lyell’s manual validation process was slow and not scalable. “We would compare screenshots to assert that each environment matched our specifications. This was laborious and prone to human error,” says Adin Stein, head of IT, cloud infrastructure, and cybersecurity at Lyell. “The process would take anywhere from 2 to 3 weeks.”
Lyell wanted to increase the efficiency and reliability of its compliance validation workflows using automation, not only for the initial implementation but also for periodic system updates. This was important so that Lyell could gain the agility that it needed to adopt new technologies and make frequent upgrades, without the barriers created by manual validation reporting. An AWS customer since 2018, the company turned to the range of curated industry solutions on AWS to streamline this labor-intensive process. It worked with AWS Professional Services, a global team of experts that help customers realize their desired business outcomes when using the AWS Cloud. “What sets AWS apart is its breadth and depth of services and expertise and its commitment to the healthcare and life sciences industry,” says Stein.
What sets AWS apart is its breadth and depth of services, its expertise, and its commitment to the healthcare and life sciences industry."
Head of IT, Cloud Infrastructure, and Cybersecurity, Lyell Immunopharma
Solution | Building Rapid Q on AWS to Automate Compliance Validation
Working with its internal quality team, Lyell built Rapid Q, an automated reporting solution for compliance validation, to assess and document every code change made to its infrastructure. “With Rapid Q, we automated not only the specifications that define each environment or application but also the validation testing,” says Stein. “As we make changes, we can run tests with the push of a button, decreasing the time that it takes to validate compliance from weeks to minutes. We can also generate reports for our quality team automatically.”
When Lyell makes any change to the software code base on its systems, a continuous integration (CI) workflow is initiated and runs a series of tests to qualify the installation. These test results are posted to Amazon Simple Storage Service (Amazon S3), an object storage service offering industry-leading scalability, data availability, security, and performance. Each incoming test result initiates workflows to generate Rapid Q reports, powered by AWS Lambda, a serverless, event-driven compute service that lets organizations run code without provisioning or managing servers. To verify that none of the messages are lost and prevent the system from becoming overwhelmed with multiple incoming changes, Lyell relies on Amazon Simple Queue Service (Amazon SQS), an automatic, fully managed message queuing service.
The Rapid Q system parses the data from the test results to generate automated compliance reports and confirm that the installation meets compliance specifications. Lyell also uses Amazon Simple Notification Service (Amazon SNS), a fully managed messaging service for both application-to-application and application-to-person communication, to send out notifications each time a new Rapid Q report is generated or alerts if an issue arises.
With this automation in place, Lyell can spend more time writing test cases and less time documenting changes, identifying areas of compliance risks, and performing exploratory analytics. To complete the auditing process, it uses Amazon DynamoDB, a fully managed NoSQL database service that provides fast and predictable performance with seamless scalability, to store data and re-create compliance documentation. Multiple systems use Amazon Relational Database Service (Amazon RDS), a collection of managed services that makes it simple to set up, operate, and scale databases in the cloud, to connect to Rapid Q for validation, including Lyell’s commercial environment monitoring and endotoxin testing systems. With Rapid Q, Lyell has achieved significant time savings and gained a scalable, paperless environmental monitoring solution that is future proof.
Outcome | Future Proofing GxP Validation on AWS
About Lyell Immunopharma
Lyell Immunopharma is a clinical-stage T-cell reprogramming company headquartered in South San Francisco, California, dedicated to developing curative cell therapies for patients with solid-tumor cancer.
AWS Services Used
Amazon Simple Storage Service (Amazon S3) is an object storage service offering industry-leading scalability, data availability, security, and performance.
AWS Lambda is a serverless, event-driven compute service that lets you run code for virtually any type of application or backend service without provisioning or managing servers.
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Amazon Relational Database Service (Amazon RDS) is a collection of managed services that makes it simple to set up, operate, and scale databases in the cloud.
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Amazon DynamoDB is a fully managed, serverless, key-value NoSQL database designed to run high-performance applications at any scale.
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