Table of Contents
Chapter One: Introduction
Clinical trials are a crucial stage in the development of pharmaceutical products. While the ultimate goal of the trial stage is to prove the efficacy of a treatment and to clear its path to market, pharmaceutical organizations face a number of hurdles. Chief among these is manufacturing.
During the clinical stage, firms must scale production, refine processes, and implement a manufacturing practice that will both serve trial populations and transfer to commercial production. Processes evolve rapidly during the clinical phase, and proving adherence to rigorous GMP guidelines is a time-consuming process.
The stakes are high during trial manufacturing. Getting clinical manufacturing right is key to bringing new drugs to market on schedule.
Tulip can help pharmaceutical manufacturers entering clinical trials operate with the agility necessary for successful, complaint trial manufacturing.
By improving process flexibility, automating traceability, and streamlining compliance during clinical trials, Tulip gives pharmaceutical firms and CDMOs the tools they need to navigate this important stage.
Chapter Two: Fulfilling Trial Design While Setting a Foundation for Scale
Clinical trials are often the first time that a new drug is manufactured outside of a lab setting. For many firms, the painstaking work of developing new treatments and seeking approval means manufacturing enters discussions late. As a result, processes aren’t fully established. Adjusting and documenting necessary changes can create a substantial compliance burden. All of these pressures are compounded by ambitious release schedules, and every month of delay can significantly impact a drug’s lifetime revenue.
Further, existing software systems are designed for the stability and predictability of commercial pharmaceutical manufacturing. These systems aren’t flexible enough for the variability manufacturers encounter during the clinical phase, and their time-to-value may exceed the trial period.
An expert at a leading CDMO described the challenge succinctly:
“For small-scale GMP manufacturing, many systems are still easier to accomplish via pen and paper. Many new electronic tools exist for the pharmaceutical industry, but being strategic about which ones to incorporate into small manufacturing processes is difficult. Many systems are difficult to justify on a cost-benefit basis and may be needlessly complicated.”
While all of the challenges of clinical manufacturing are interrelated, we can break them into several key areas:
Rigorous requirements for traceability – Small batch sizes, evolving processes, and manual documentation complicate traceability. Gathering end-to-end records of a given batch is highly manual, and the data often needs to be transcribed from multiple paper sources, creating opportunities for error.
Small and variable batch sizes – Clinical trials often require small batches and batches of varying size to serve each trial population. Manufacturing needs to be flexible enough to adjust to the demands and process changes required for multiple batch sizes.
Clinical manufacturing processes evolve over time – Clinical trial manufacturing has the complicated task of translating benchtop results into a manufacturing setting while also laying the foundation for commercial production. The inherent variability of chemical and biological APIs means that lab processes won’t always work the first time in larger format.
Clinical manufacturing must scale – Clinical manufacturing must be designed to scale. This is as true for the hardware needed to produce at scale as it is for the software systems that orchestrate and track production.
Documenting quality can slow production – Many production systems aren’t designed with the end-user in mind. As a result, paper is still common in production facilities. This manual documentation can significantly slow production, and the labor required can add unnecessary expenses over time.
Data isn’t available when you need it – Data taken by hand isn’t immediately available for analysis. The evolving nature of clinical trial manufacturing requires real-time visibility, and even modest delays in data availability can lead to large inefficiencies in the long-term. Further, organizations working with CDMOs often set KPIs with their partners and expect regular reports. In these cases, communication and reporting take time and labor away from critical manufacturing tasks.
Proving compliance is burdensome – Compliance is essential to maintaining product schedules and budgets. Collecting the information necessary to prove compliance, however, can be challenging during clinical trials. The lack of automated systems and abundance of manual documentation can make proving compliance an expensive, time-consuming part of manufacturing. Existing software solutions aren’t designed for the clinical phase – Existing software solutions are designed for the predictable, replicable processes characteristic of validated commercial manufacturing. They don’t offer the agility, flexility, or real-time visibility needed to navigate the clinical phase.
Chapter Three: Navigating Clinical Trial Manufacturing with Tulip
Tulip is a no code application platform designed for fast moving, compliant manufacturing environments. Tulip offers all of the functionality you need to coordinate and track production in GMP facilities, as well as a suite of tools for improving the efficiency of validated lines. The key advantage is how Tulip enables agility and flexibility.
Where traditional solutions can take 15-16 months to scope, design, and deploy, Tulip applications can be configured and deployed in weeks. Instead of building a complex, monolithic solution, Tulip lets you bundle functionality out of individual applications. From interactive digital SOPs to materials management and supply chain visibility, you can build applications for every step of the manufacturing process. Applications can be built, deployed, and iterated in parallel, making Tulip ideal for agile, evolving projects. In practical terms that means more flexibility, real-time process visibility, and a streamlined approach to quality and compliance.
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’s how Tulip can simplify clinical manufacturing.
Agile Deploys – Time-to-value takes on new meaning in a rapid, high-stakes period like clinical manufacturing. Tulip let’s you deploy fast and iterate applications as necessary. You can build and deploy multiple applications in parallel, letting adapt the system to your needs as it evolves.
Process flexibility – Tulip makes it simple to adjust your manufacturing systems to meet evolving demands. Most changes can be made beneath the layer of validation, meaning no trade-offs between compliance and continuous improvement. Applications are designed and hosted so that changes to one application won’t impact the overall function of the system.
Automated End-to-End traceability with IIoT – Tulip is IIoT native, making it simple to collect data from the devices, sensors, and equipment in your plants. Tulip can take information collected from supply chain, materials management, and human-centric applications and compile it with this IIoT data. This gives you an easily accessible, complete account of every batch.
Real-time visibility and instant analytics – Tulip comes with easily configurable analytics. Data from each of your data streams can be aggregated and displayed on easy-to-configure dashboards. This gives you real-time visibility into manufacturing processes as they unfold, and the information you need to make better decisions in the moment.
Digital history records for simplified compliance – Tulip applications form the foundation for digital history records. Instead of manual, paper-based documentation practices, Tulip apps create a complete record of the manufacturing process, and are fully compliant with 21 CFR Part 11. These records are easily navigable and accessible, making it much easier to access the materials you need to prove quality and compliance
Effortlessly scale up or out – Traditional software systems are bespoke for each facility. This makes scaling up and scaling out a challenge, as software needs to be redesigned for each new facility. Tulip can effortlessly scale across facilities, alleviating some of the common pitfalls of tech transfer. Once the apps are built, modifying them for new lines takes hours, not months.
Chapter Four: Conclusions
Clinical trials are an exciting and fraught period in a therapy’s lifecycle. While only a small percentage of new products win FDA approval, the upside for approved drugs can be enormous. Manufacturing is one of the key ways of ensuring that new therapies stay on track.
Tulip can help ensure a successful trial period by enabling manufacturers to tackle clinical manufacturing’s greatest challenges: evolving processes, scaling up, and cumbersome requirements for proving quality and compliance.
If you’re curious how Tulip can help you during clinical trial manufacturing, get in touch.