Flying Blind: Why The Biopharma Industry Needs Real-Time Microbial Detection

In biopharma, time isn’t just money, it’s product, safety, and reputation on the line. Yet for decades, manufacturers have been operating in the dark, waiting five to twenty-eight days for microbial test results that determine whether a batch is safe or contaminated. That delay can cost companies tens to hundreds of millions of dollars per incident.

On a recent episode of Life Sciences Decoded, I sat down with Dr. Jack Regan, CEO, CTO, and Co-Founder of MantaBio, to discuss how his company is tackling this massive bottleneck with automation, PCR-based detection, and real-world insights.

The Cost of Flying Blind

In the biopharma world, manufacturing happens in warm, nutrient-rich bioreactors which are perfect not just for growing therapeutic biologics like Keytruda or Humira, but also for harboring microbial contamination.
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“If you're waiting 28 days to detect contamination, you're flying blind,” Regan explained. “You could be losing a $20 million batch or worse, contaminating multiple lines from a single source.”
Contamination risks extend beyond product loss. A single event can lead to:
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• Line or plant shutdowns
• Missed market windows
• Product recalls
• FDA fines and regulatory fallout

​MantaBio’s 2-Hour Solution
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Enter MantaBio, a company designing a fully automated, PCR-based microbial detection system called MantaVision, purpose-built for the demands of biomanufacturing.

“We’re not adapting clinical tech into biopharma,” Regan noted. “We’re building this from the ground up for industrial-scale testing.”

​Unlike traditional methods based on century-old cell culture, which involve plating samples and waiting for colonies to grow,  MantaBio delivers results in just two hours. That speed allows manufacturers to detect contamination early, intervene faster, and avoid unnecessary product loss.

Designed for Manufacturing Environments

A major advantage of MantaBio’s approach? It eliminates one of the biggest risks in microbial detection: sub-sampling errors. Traditional methods often rely on testing small sample volumes, which can easily miss low-level contamination. MantaVision is engineered to process larger volumes, increasing the statistical likelihood of catching contaminants before they become costly.
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And it’s not just about volume, it’s also about usability. The system is:

• Fully automated
• Run on-site - no shipping to reference labs
• Easy to use - no PhD required

As Jack Regan puts it: “It’s like the Keurig of molecular biology. Pop in your sample, and out comes a genetic result you can trust.”
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A Heart Monitor for Your Bioreactor

What makes MantaVision more than just a faster test is how it integrates across the entire manufacturing process. The MantaVision is intentionally modular by design, so that customers can easily scale up to meet their testing needs. Most companies would like to deploy 4-5 systems per line, testing at multiple stages, fermentation, harvest, purification, and final product.  It’s like having a continuous heart monitor for the bioreactor.

“If something spikes, you know early,” Regan explained. “You can pause, isolate, and resolve the issue before it snowballs.”

That kind of real-time insight doesn’t just save product. It gives manufacturers a clear path to more reliable operations, fewer recalls, and shorter time to market.

Not Just Faster — Smarter

Beyond rapid detection, MantaBio’s platform also supports speciation which is the ability to identify which microbe is present, not just whether contamination occurred. That insight helps teams perform root-cause analysis and prevent recurrence.

“The goal isn’t just speed,” Regan said. “It’s confidence in the results, in the product, and in the decisions you make next.”
 
What’s Next for MantaBio?

While the system is still in development, MantaBio is already working closely with leading biomanufacturers to ensure the platform meets real-world needs. The team is conducting rigorous validation, refining usability, and aligning with evolving regulatory expectations.
“There’s currently no dominant player delivering this kind of molecular testing in biopharma,” Regan said. “We’re building the system the industry has been asking for.”

​And that could change everything.

Want to learn more?
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Visit mantabio.com or follow MantaBio on LinkedIn for updates.
Listen to the full conversation on Life Sciences Decoded