In recognition of their potential to serve new patient populations, the FDA offers fast-track validation for cell and gene therapies. But to receive validation the FDA requires a software platform for managing and orchestrating the manufacturing process.
This is where Tulip can help.
Tulip is an application platform built for agile environments. Tulip provides all of the functionality you need to monitor and coordinate production in a GMP facility. And it does so in a way that rises to the speed, flexibility, and traceability required for personalized therapies.
Traditional production management solutions are slow to implement. The average roll-out takes 15-16 months. Waterfall-model deploys mean that late-breaking or changing requirements can push back timelines and delay time-to-value.
Further, these systems are hard to modify. Small customizations can take weeks to months. The costs add up.
With Tulip, manufacturers build applications and deploy them in days or weeks, not months. The platform is designed specifically to enable fast time to value in regulated environments. Tulip’s application builder lets you build multiple applications in parallel, deploy simultaneously, and iterate continuously. Applications can be modified, reconfigured, and scaled without harming other applications or upsetting validated processes. The result is increased flexibility, faster manufacturing cycles, and more visibility into processes.
We currently work with some of the top pharmaceutical manufacturers in the world. Our pharmaceutical customers use Tulip for tasks as diverse as equipment monitoring, digital history records, and as an end-to-end production management and orchestration system for oral solid dose manufacturing. Tulip fits your production lines–not the other way around.
Here are some of the ways Tulip can help address the specific challenges of cell and gene therapy manufacturing.
Agile Deploys – Tulip provides the fastest time-to-value of enterprise manufacturing solutions. With Tulip, manufacturers can implement site-wide solutions using agile methodology–designing targeted, workable solutions fast and in parallel. This way you can introduce functionality and create value without spending months gathering requirements and designing a monolithic solution.
Native IoT to monitor processes – Tulip is an IIoT native platform. This means that Tulip can connect to your devices, sensors and equipment out of the box. This reduces the amount of time spent manually collecting data, and makes each of the data streams necessary for proving quality and compliance instantly available.
Real-time process visibility – Real-time analytics are an essential tool for minimizing lead-times and ensuring quality. Tulip instruments your manufacturing processes, collecting data from equipment, machines, sensors, and operators automatically. All of the data collected by the platform is stored in easy to configure tables, and can be visualized in customizable analytics dashboards. This level of visibility typically exists beneath the level of validation, and can help speed production by eliminating downtime and improving production routing processes.
Automated Traceability at the Patient Level – Ensuring traceability at the batch level takes a tremendous amount of manual effort. With Tulip, batch history and genealogy are automatically recorded and stored in searchable databases. Tulip apps can be used in production, in clinics and at the point of care, as well as to coordinate logistics, making true end-to-end traceability possible. This makes it simple to find the information you need for each batch, and simplifies
Scalable, transferable software systems – One of the biggest challenges of traditional manufacturing systems is up to production and scaling-out to CDMOs. Because software solutions are typically bespoke, each new facility requires a new solution, built from the ground up. Tulip applications scale-up and -out seamlessly. Full production systems can be transferred to new facilities. New configurations can be completed in hours and days, not months. If you’re working with a CDMO, the applications you develop during the clinical stage can be rolled-out to the new sites for the next phase.
Digital History Records – Traditional history records are manual, paper-based procedures. Tulip thinks about history records differently, making it easier than ever to access the parts of history records necessary for compliance.
Simplified Compliance – Simplified compliance is a natural result of better visibility, accessible data, and digital history records. Tulip collects all of the data and records you need to prove quality and compliance.