Reality check for biotech

It’s just past 7 a.m. at the GEA Application and Technology Center for New Food and Biotech. The alarms are cleared, and the system with its 500-liter bioreactor is running smoothly for the first time. The team spent the night fine-tuning the controls. Now the display shows a value no one expected.

The organism in the reactor is generating nearly three times more heat than in the lab experiments. The cooling system can barely keep up. GEA Test Engineer Sofija Milošević at the terminal remains calm, checks the sensors and adjusts the control parameters.

Then she sums up the purpose of this test: “It’s a good thing we’re seeing this here – and not in a factory.”

Why Europe needs a practical test

The new GEA Application and Technology Center (ATC) in Sarstedt, south of Hannover, is neither a showroom nor a substitute for a lab. It is a place for testing, data collection and early decisions. This is where it becomes clear whether a biological concept can become a robust industrial process. That step is bigger than it may seem. 

For example, a large portion of the nutrients used in European animal husbandry, including certain amino acids and vitamins, currently come from China. Not because Europe could not produce them itself, in principle – but because there is a gap between discovery in the lab and production in the factory. So far, very few have bridged it.

What at first sounds like a minor technicality could have direct economic consequences. If the supply chain were to falter because of political tensions, trade barriers or rising transportation costs, Europe’s food supply would feel the impact.

The science behind alternatives has long been available: in laboratories, studies and funding programs. To win approval for a new substance in Europe, companies increasingly need to describe not only the molecule but also the (lab-tested) process behind it: the organism, the individual processing steps, the hygiene concept, the control points and the reproducibility. For those final steps, a test center is exactly what’s needed to translate research into a process that works reliably, reproducibly and economically.

“Europe funds the science and stands by while the scale-up happens elsewhere,” says Frederieke Reiners, Vice President New Food & Biotech, GEA. “That is starting to change. But it needs infrastructure, not just declarations of intent.” 

Four stages to production

The four-part path from the lab to the factory begins with questions in the lab: Does the biology work? Does the organism produce the target compound? Does the cell line grow? Does the basic idea hold? 

In the second step, a test center such as GEA’s ATC checks whether the process would work on an industrial scale. A product must be recoverable at stable quality with a solid downstream route.

After that, initial batches can be produced in a demonstration plant under conditions that correspond to later food production. This enables product development and market testing. Only in the industrial plant does it ultimately become clear whether the entire process is viable on a large scale.

Each stage has its own logic. Each requires different equipment, data and decisions. Each stage makes the next one possible.

Marcel Oogink is setting up the Biotechnology Fermentation Factory (BFF) in Ede, the Netherlands, with GEA’s support. The open demonstration facility gives companies the opportunity to continue testing under food-grade conditions after the ATC stage. For him, the path from lab to factory is not one big leap but a chain of decisions, each of which needs its own evidence. 

Until today, this chain has been seen far too rarely in the industry.

What the practical test reveals

Let’s get back to the fermenter and the unexpected heat load. The excess heat from the experiments is not merely a glitch but crucial information. For the company working with this organism, a fixed requirement has just been discovered. At the industrial level, the cooling system must be designed differently from the very beginning.

This realization required extra work and caused some headaches. In a completed factory, however, it would have cost millions or brought the entire project to a halt.

Moments like this happen repeatedly at the ATC, in different forms. In another case, a small preliminary test revealed massive foaming. On a larger scale, this would have been nearly impossible to control. Now the control system can be designed with greater precision than planned, and the nutrient addition can be adjusted.

Another customer faced a very practical question: How can protein be extracted from a yeast cell? To do this, the cell walls first had to be opened. At the ATC, engineers investigated various pretreatments and process conditions for using a high-pressure homogenizer. The goal was to release as much protein as possible while keeping energy consumption in check.

Subsequent steps for concentration and purification also delivered important insights. By comparing separation and filtration, the team could select the appropriate separation technology for the process. In one of the tested steps, the team got protein yields of more than 90 percent.

Klaus Stojentin, a member of the GEA Executive Board responsible for the Nutrition Plant Engineering Division, is well aware of the gap between laboratory results and real-world plant conditions. “The most exciting technology only matters if everything around it works,” he says. “And you do not learn about ‘everything around it’ in the lab.”

An early 'no' protects against the wrong 'yes'

Not every test leads to a way forward. That can sound like a setback. But clarity is precious when changes are still affordable.

In trials with one customer, it became clear that the organism simply wasn’t productive enough. The yield was far below what would be economically viable. No plant optimization or process adjustment could have fixed that. The company reviewed its business case and returned to strain development.

“Sometimes the best result of a test is a ‘no,’” says Reiners. “A ‘no’ that comes early enough protects against the wrong ‘yes.’”

Herein lies the sober industrial logic of the ATC: Companies that test early can change course early. Those who test too late, or not at all, may end up investing in an assumption that doesn’t hold up under real-world conditions.

This knowledge is not gained at a desk. It arises from hands-on experience under conditions that come close to industrial reality.

So-called regulatory sandboxes, which are being discussed more widely in Europe, follow the same logic: Companies and authorities build a shared understanding together before the actual approval application is submitted. The ATC is not a regulatory tool in itself. But it provides exactly the kind of data that makes such guided learning more meaningful and robust.

From pilot to factory

Solar Foods shows what is possible at scale. The Finnish company produces Solein®, a microbial protein created from CO2, hydrogen and minerals. They use renewable energy, independent of farmland, weather and season.

GEA built Solar Foods’ first commercial plant as a turnkey project and is now planning Factory 02 – the first large-scale industrial protein plant – which will be built in Lappeenranta, Finland.

Solar Foods is proving that the chain can work, if every step is taken with care.

Process knowledge becomes production readiness

Morning in Sarstedt is long gone. Milošević adjusted the control and revised the feeding strategy; the plant is running stably. The unexpected heat generation has become a concrete guideline for the next scale-up.

The results now provide a solid basis for decision-making. They confirm or validate the business case, clarify the feasibility of production and give investors confidence. The company that developed this system now knows what it needs for the next plant. It knows the opportunities and limitations. 

“That’s the real product of our ATC,” says Milošević. “We work with batches and protocols, but at the end of the day, it’s about the understanding that makes the next step possible.”

Europe has strong science. Germany has strong engineering. What the industry needs are places where both meet under conditions close enough to industrial reality to matter. 

Sarstedt is now one of those places.