By Kelly Stewart
It’s hard to reconcile today’s manufacturing systems with how they operated three scant years ago. The speed with which the industry united to develop, produce, and distribute a novel vaccine is truly astonishing.
Without an unprecedented level of precision and collaboration at the preclinical stage, this wouldn’t have been possible.
In this white paper, we’ll explore the promise of digital manufacturing execution systems (MES) for preclinical process development. We’ll begin with a bird’s-eye overview of the entire drug production lifecycle, and then zero in on what happens at the preclinical stage. In conclusion, we’ll review MES capabilities in the context of preclinical needs and priorities.
After the initial R&D, there are three sequential stages to the drug production lifecycle: preclinical, clinical, and commercial.
Manufacturers have a unique set of needs and considerations at each stage.
Preclinical development is all about process. While R&D discovers the product, scientists discover the process for making that product.
“The stakes are high at the preclinical stage because this is when drug candidates are initially examined for safety and efficacy before clinical trials.”
— Anastasia Wengrowski, Director of Strategy at Apprentice
Since the method for figuring out that process is largely trial and error, small scale experimentation is what’s needed at this stage. Procedures and testing are constantly in flux, so it’s crucial to be nimble.
Preclinical equipment, tests, studies, and materials are all smaller in scale and volume to accommodate this need for flexibility.
COVID sparked an urgency for the utmost speed and accuracy in preclinical mRNA research. Drug developers around the world suddenly rallied around a common goal: discovering how to produce a vitally important drug at a never-before-seen rate.
Precision, speed, and cross-team collaboration were no longer nice to haves: they were vital to develop a brand-new process for a novel vaccine as quickly as possible.
Plus, there was the added complication of travel restrictions making onsite aspects like site visits virtually impossible. As Apprentice CEO Angelo Stracquatanio puts it, “They had to solve COVID, with COVID around them.”
But were traditional process development standards flexible enough to adapt to the challenge of the century?
Advanced manufacturing execution systems don’t grow on trees, but paper certainly does. Paper has its place in the history of data documentation, but its position in the future of manufacturing grows less certain every day.
So how did paper become a problem? In the past few decades, the demand to get critical products and drugs to market faster has risen, as have the stakes. Paper-based manufacturing systems lead to challenges with inflexibility, errors, security, time, and profit. In addition, the latency and physicality of paper means that it can never be in two places at once. This leads to dangerous silos and communication gaps between departments that need to be on the same page.
“There are so many silos within manufacturing, and data are not being leveraged at different levels.”
— Angelo Stracquatanio, Co-Founder and CEO of Apprentice
Paper-based systems contribute to losses in speed and productivity. These types of inefficiencies include:
In short, paper is no longer sufficient to meet the needs of modern manufacturing.
At the preclinical stage of process development, flexibility is key. That’s why a shift from paper to digital MES is especially crucial at this early stage.
The need for multiple iterations at small scale demands a system that can outpace paper and keep up with fast-changing scenarios.
“Even at the preclinical stage, processes should be analyzed with a view to industrial-scale production and the conceptualization of a pilot plant.”
— Daniel Maier, Zeta Biopharma, Director of Engineering and Services
However, while COVID and the shift to remote work has pushed pharma to move to digital technologies, many manufacturers are still hesitant to take on the burden of converting from paper. Paper is a trusted, traditional medium, and it's understandable that there's resistance to embracing the shift to digital.
But remaining on paper—whether for processes, documentation, authorizations, resource management, or other purposes—is highly inefficient and prone to manual errors.
Advances in technology have enabled the rise of on-premise and cloud-based digital MES. Leveraging MES at the preclinical stage of the drug production lifecycle can yield innumerable benefits. Digital MES allow you to:
The benefits of digitizing your data are massive, especially at the preclinical stage.
That’s why many preclinical manufacturers are choosing to go with a digital MES from the start. Building out your manufacturing processes in a digital system from the get-go means you won't have to go back and update all of it later, or spend thousands of hours manually capturing and transferring your data to clinical development.
Looking for an MES that’s built to support preclinical benchtop all the way through to commercial manufacturing? Meet Tempo for preclinical MES.
When your drugs and processes are still in an experimental phase, Tempo’s flexibility lets you configure any needed changes in your work without having to rely on software engineers. Our cloud-based tech gives you the speed and agility you need to succeed at the preclinical stage.
Tempo lets you optimize your process operations with a system that’s specifically designed to accommodate the flexibility needed at the preclinical stage:
Best of all, Tempo for MES lets you share data and process instantly, expediting the transition from preclinical to clinical. Our multi-stage platform keeps your global teams connected, empowered, and in sync through every stage of the drug production lifecycle.
EXPLORE PRECLINICAL SOLUTIONS
Got questions about preclinical MES? We’re here to help! Reach out to our team of experts to discuss your preclinical research needs and how our platform can help you reach your goals for quality, speed, and safety.
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