White Paper

Digitizing Preclinical Process: No Longer Optional

The world is changing. Is your preclinical process up to date?


By Kelly Stewart

Executive Summary

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.

Jump to:


Production Lifecycle: An Overview

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 stage

  • Goal: Taking a newly discovered molecule and figuring out the process to turn it into a safe medicine
  • Challenges: Adapting to processes and testing that are constantly evolving 
  • Resources: Limited IT involvement and technical resources

Clinical stage

  • Goal: Taking the process determined in the preclinical stage and figuring out how to make it repeatable at scale
  • Challenges: Making enough drug products that are safe enough for clinical trials on animals and humans; deployment to operating suites limited to a few select locations
  • Resources: Limited IT involvement and technical resources

Commercial stage

  • Goal: Making a high-yield, high-quality batch as frequently and quickly as possible
  • Challenges: Keeping overhead low at scale; connecting operating suites and collaborators across geographies and facilities
  • Resources: Significant IT involvement in matters such as budget spend, consolidation, and sourcing approved vendors

Preclinical Stage: What’s at Stake

Preclinical manufacturing is all about process. While R&D discovers the product, preclinical discovers 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.

Preclinical Development in the Time of COVID

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?

The Problem with Paper

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: 

  • Slower execution
  • Lower yield per batch
  • More deviations

In short, paper is no longer sufficient to meet the needs of modern manufacturing.

What This Means for Preclinical

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.

Why You Need an MES for Preclinical

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:

  1. Get real-time data. Preclinical research demands a huge amount of data to be captured, recorded, and transferred so that the correct process can be identified from the rest. Cloud-based MES lets you effortlessly record and share this data in real time.
  2. Iterate faster. Real-time visibility lets you record and analyze your experimental data at record speed for a continuously evolving feedback loop. This sets the stage for faster iterations and a more efficient workflow to clinical testing.
  3. Automate transcription. Human transcription comes at a significant cost of time and resources. Multi-device MES, such as our Tempo for MES, lets you streamline this task through automated data capture, eliminating the need to manually transcribe from paper. By achieving full data capture with just the click of a button, you can free up time and capital for your top preclinical priorities.
  4. Eliminate errors. People are great, but at the end of the day, we’re only human. Manual transcription and calculations can never be free from error. That’s where digital MES comes in. Digitizing transcriptions and automating calculations let you minimize costly errors so you can trust the accuracy of the data you receive.
  5. Achieve your Quality by Design goals. MES gives you a way to identify and monitor quality points to make sure your preclinical process meets the target quality standards. With digital MES, your drug won’t only be tested, it’ll meet the highest quality standards from the start. By building in quality at the preclinical stage, your process will be easily adaptable to meet the stricter requirements needed for clinical and commercial.
  6. Make tech transfer a breeze. Wouldn’t it be great to simplify the transfer of data from preclinical to clinical? Digital MES makes this dream a reality. What’s cumbersome and lengthy on paper becomes effortless in digital. Through our multi-stage digital MES, tech transfer becomes as easy as logging in.
  7. Get support in a range of devices. Digital MES gives you the freedom to streamline experimental data recording through integration with web platforms as well as mobile devices such as headsets and tablets.

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.

Closing Thoughts: Tempo MES for Preclinical

Looking for an MES that’s built to support preclinical benchtop all the way through to commercial manufacturing? Meet Tempo for preclinical MES.

DISCOVER TEMPO
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:

          ✓ Create digital processes without code

          ✓ Work where you are—not where your workstations are

          ✓ Capture superior data with built-in intelligence

          ✓ Experiment faster with real-time feedback

          ✓ Parameterize your variables for better comparison and analysis

          ✓ Build your process with a Quality by Design approach


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

Meet Our Preclinical Problem Solvers

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.

SAY HELLO

References

  1. “Introduction to Quality by Design.” Alcami, www.alcaminow.com/blog/introduction-to-quality-by-design.
  2. Maier, Daniel. “Planning for Production Scale.” The Medicine Maker, 17 Oct. 2018, themedicinemaker.com/discovery-development/planning-for-production-scale.
  3. Office of the Commissioner. “Step 2: Preclinical Research.” U.S. Food and Drug Administration, 2019, www.fda.gov/patients/drug-development-process/step-2-preclinical-research.
  4. Shanley, Agnes. “Bringing Six Sigma to Preclinical Pharma R&D.” Www.pharmtech.com, vol. 15, no. 11, 5 Nov. 2020, www.pharmtech.com/view/bringing-six-sigma-to-preclinical-pharma-r-d2.
  5. Stracquatanio, Angelo. “Pharma Manufacturing World Summit: The Rapid Adoption of Intelligent Manufacturing & Pharma 4 during COVID.” Vimeo, 19 May 2021, vimeo.com/552477760.
  6. Wenslow, Robert, and Ann Newman. “Drug Development - Don’t Overlook Key Preclinical Research.” Drug Development and Delivery, 29 Mar. 2016, drug-dev.com/drug-development-dont-overlook-key-preclinical-research/.

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