Computational Bioprocess: The Next Frontier

Every day, scientists discover molecules with the potential to save lives and redefine industries. Yet, too many breakthroughs remain stuck in the lab, out of reach for those who need them most. The journey from discovery to market is slow (years), expensive (hundreds of millions of dollars), and fraught with inefficiencies. Bioprocessing sits at the core of this challenge.

Today, bioprocessing relies on time consuming experimentation where unpredictable outcomes and resource constraints drive up product costs, risks, and timelines. Innovation is delayed, leaving patients waiting.

At Ark, we’re building a better way forward. By harnessing advanced computational tools, especially high-fidelity simulation, we enable scientists to make data rich decisions. With computational bioprocess, scientists can conduct virtual experiments, optimize processes, de-risk development and bring life-saving breakthroughs to market faster than ever before.

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The Challenge: Bioprocess is Complex and Filled with Uncertainty

Bioprocessing is inherently complex. Cell culture is highly dynamic, characterized by non-linear behaviors influenced by hundreds of interdependent factors. Given the complexity of bioprocessing, relying solely on literature, subject-matter experts, or statistical analysis often proves insufficient. Increasingly complex products only magnify the challenges. And so we turn to empirical knowledge – more experiments.

But, conducting more experiments is time-consuming, expensive, and constrained by limited resources and tight deadlines. Even large operations will only have 24 bioreactors available at a time, and once you account for triplicates and baseline controls, only a few hypotheses can be tested in each cycle. So we do our best – ruthlessly prioritizing our experimental plan and then we wait. Weeks later, after the cell culture finishes and analytics runs their tests, we receive back the, often noisy, data packet. We analyze the precious data, and if we still have time, determine the next best experiment. The cycle begins again.

The limited experiments that we are able to run is simply no match for the complexity of the system. We need at least an order of magnitude more experiments, but with today’s infrastructure this is simply unattainable. And so, we are stuck testing out fewer new molecules, settling for processes that are good-enough, and shipping products that have manufacturing risk.

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The Solution: Computational Bioprocess

The next leap forward in bioprocessing is simulation—true high-throughput experimentation. By running thousands of virtual bioreactors simultaneously, feedback cycles dramatically shrink. Every scientist can have the best of computation at their fingertips allowing scientists to iterate faster, gain deeper process insights, and use their time and resources more effectively.

Physical experiments become very selective, and only those meaningfully expanding design space are strictly required. Optimization within the design space can be done entirely by computational bioprocess.

Imagine running 1,000 high-throughput bioreactors at once, performing full factorial designs or scaling up from bench to commercial production seamlessly— in minutes. Computational bioprocessing isn’t just about faster optimization; it redefines how molecules go from cell line development to production.

With computational bioprocess, scientists can:

• Gain a complete system understanding, including the effect of time-based interactions, by running more experiments in a week than previously possible in a decade.
• Determine the combination of control parameters, mode of operation, and bioreactor equipment to maximize yield, reduce costs, and ensure process robustness.
• Quantify PCO2 in the target bioreactor and correctly tune PID loops for perfusion processes, ensuring successful scale-up first time right.
• Pre-run hundreds of potential deviations to improve process robustness and determine the best responses.

This revolution shifts process development timelines from years to months, enabling labs to test 10x more molecules annually while reducing costs. The result? More accessible therapies and a dramatic increase in the number of life-saving products reaching patients.

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Best of Science Meets Best of Computation

At Ark, we’re pioneering computational bioprocess - a model-first approach that combines the very best of scientific knowledge in biology, chemistry, and physics with the predictive power of machine learning and AI. This technology allows us to simulate experiments virtually with precision and speed.

Our approach leverages mechanistic models built on established scientific equations and principles, ensuring the accuracy and reliability of simulations. We have been methodically collecting, vetting, and interconnecting equations that capture every part of the bioprocess, creating a dynamic and harmonized framework.

Where current scientific knowledge is incomplete, we incorporate machine learning and AI to analyze historical data and uncover patterns guided by our scientific understanding of the system. By merging proven scientific principles with advanced data-driven approaches, computational bioprocess creates dynamic, adaptive simulations that can be used to identify optimal strategies within the known design space or to determine the next best experiment to expand the design space.

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Conclusion: A Future Within Reach

Bioprocess stands on the brink of a revolution—its Gutenberg moment.

At Ark, we are redefining bioprocessing. By replacing outdated methods with computational experimentation, we empower scientists to achieve more breakthroughs – faster. Soon, today’s methods will seem as antiquated as waiting days to develop film. Computational tools will be the new standard—faster, smarter, and more precise.

Imagine a world where life-saving drugs reach patients in half the time, five times as many therapies make it to market each year, and access to critical treatments is universal. Computational bioprocess makes this future possible.

Together, we can accelerate innovation, transform healthcare, and deliver life-changing therapies to those who need them most—faster than ever before. Join us in shaping this future.