Only a handful of biopharmaceutical companies have heard of a small microbioreactor developer that calls itself Erbi Biosystems. It hasn’t been in stealth mode. Its engineer-founders just weren’t focused on marketing. Instead, they were fixated on building the best automatic, integrated, milliliter-scale bioreactor.

Since bringing in new money and management about two years ago, Erbi (an initialism of the company’s tagline, “Enabling Rapid Bioprocessing Innovation”) has become a commercial company.

Erbi’s first product—which uses the company’s foundational technology platform, the Erbi Breez™—was launched in 2020. It is a 2-mL bioreactor that is designed to provide fully automated, continuous perfusion, Erbi’s CEO, Michael Chiu, PhD, says. “There are two broad applications that benefit from small-scale continuous perfusion: bioprocess process development and cell therapy.”

Erbi Breez, a 2-mL microbioreactor
The Erbi Breez, a 2-mL microbioreactor, provides fully automated, continuous perfusion in a small form factor. It can have cell densities of 200 million cells/mL—about twice that of stirred-tank reactors.

He adds that Erbi has a distinctive approach to process development, cell line development, or media development. The thing that differentiates Erbi, he elaborates, is the ability to perform continuous processing, as well as fed-batch processing.

Process development and cell therapy

“We have data indicating that the Breez mimics the results of bioreactors from 3 to 10 L,” Chiu reports. “Unlike those systems, the Breez can run four experiments on one linear foot of bench space. This lets researchers test many different parameters cost effectively. The Breez single-use microbioreactor is fully contained and automated, too, so a researcher can just drop in the cassette and run the experiment.”

Operational costs for the 2-mL Breez are lower than those for large bioreactors, Chiu asserts. He points out that with large bioreactors, it is necessary to use more media, which may cost $50/L to $1,000/L. So, if one were to run a large bioreactor instead of the Breez for 30 days, total media costs would be greater—to say nothing of additional expenses related to hands-on time.

“The second market, cell therapy, is really exciting for us,” Chiu states. “Scientists want to learn more about cell behavior and optimal conditions to modify and grow patient cells, especially for autologous processes.” He adds that if scientists use a 2-mL bioreactor, they can achieve higher cell densities and obtain better results—while reducing costs—than if they use a larger bioreactor.

Immediate challenges

One of Erbi’s greatest challenges, as a small company in the midst of a pandemic that has shuttered “nonessential” laboratories, is visibility or name recognition. The company’s clients include a handful of big pharmaceutical and biotechnology companies, along with a few academic laboratories.

In 2006, Erbi was formed, Chiu relates, by “two resourceful electrical engineers” from the Massachusetts Institute of Technology (MIT). “Their original work was in optical sensing for biology, but in doing that, they developed a concept for small-scale bioreactors for nonmammalian cells,” he continues. “They got a few grants and sold a few models, but commercialization wasn’t their primary focus.”

As of 2018, Erbi had compelling technology and early success in the market, but according to Chiu, the company’s progress depended on gaining more “funds and focus.” It was at this point that Chiu joined Erbi. The company has been enjoying funds and focus success ever since.

Erbi closed its most recent financing round at the end of October. This effort, which was led by angel investor Jaguar Biotech, raised $3.8 million. At the time, Chiu said, “This new funding allows us to expand manufacturing, sales, and support of our existing microbioreactor, while also funding further development of our technology platform and product pipeline.”

Now he says that Erbi is shifting its focus from perfecting the finished technology platform to commercializing it. “That means defining the product; building the quality systems and supply chain; and hiring people to build, support, and sell our instrument,” he explains. “Customers already were buying it. We just put structure around it.”

Favorable positioning

The potential for Erbi’s microbioreactor is enhanced by the manufacturing scale-down that is accompanying the rise of cell therapy and the intensified processes around perfusion. “There’s a substantial shift for new manufacturing platforms to be more intensive,” Chiu observes. “And companies often don’t have the tools for it.”

That shift includes online sensing, tightly integrated systems, and digitization. “You don’t want data islands,” he insists. “You want to connect data with other systems, to get more and better insights out of the machines. That’s where we’re focusing as we expand our product line.”

“Breez looks like a bioreactor,” he continues, “but it’s really a data-generating platform that helps our customers get the insights they need to improve their process development. Breez is more than a glass flask and an impellor, and that’s super exciting for us.”

Another benefit of the Breez is high cell densities. “They are much higher with Breez than with traditional bioreactors,” Chiu remarks. “Small stir tanks, for example, have densities of about 100 million cells/mL. We have customer data showing 200 million cells/mL, and anecdotal evidence suggests even higher cell densities.”

That’s possible because of its mixing and gas transfer technologies. The Breez uses inflatable silicone membranes to move fluid through the culture chamber, and it uses gas diffusion through those membranes to prevent bubbling and foaming. Stirred-tank reactors, in contrast, use mechanical impellors for mixing, and sparging or bubbling for gas transfer, which cause shear or foam. The message, he says, is that the Breez is gentle on cells.

Chiu contends that the Breez helps scientists do more than they can do with a stirred-tank reactor, providing better results that help researchers be more effective and get results faster and more economically. Chiu says, “Our system is simple enough that one technician with little bioreactor experience can run 12 simultaneous experiments.”

A big future

For the near term, Erbi is concentrating on building the company and enhancing its platform. Chiu expects that as customer feedback accumulates, Erbi will increase functionality to the Breez. “We’ll add more ways for scientists to learn more with our system,” he predicts. The company also is contemplating a larger version of the microbioreactor. “Two milliliters may be too small for some applications,” he acknowledges. “We also may add more inputs and outputs for analysis, integration, and data connectivity tools.” Those product expansions are likely to begin in 2021.

It’s somehow fitting that Erbi’s name, like the 2-mL bioreactor it has developed, packs a lot into a small space. The Breez has the integrated, automated capabilities associated with larger robust systems. Similarly, the company is of modest size but holds enormous potential.