Hoping to speed up scaleup through detailed modeling of bioreactors, SimVantage, which was founded in December 2021, is working with pharmaceutical companies to help them scale up their bioreactors from laboratory to industrial scale.
“We’ve created a virtual copy of a bioreactor to help with process transfer and troubleshooting,” explains Christian Witz, PhD, the company’s founder and CEO, who spoke about the technology at BioProduction in November last year. “The aim is to reduce experimental load and, thus, time taken for a full scaleup.”
SimVantage began ten years ago as a university-industry collaboration to model large-scale bioreactors. “A pharma company went to the simulation companies existing at that time and asked them to simulate a large-scale bioreactor. No one could do that, so they came to the university and asked us,” Witz.
The software is unique, he claims, because it simulates bioreactors from physical first principles. This means, he says, the same model can be used for bioreactors ranging in size from a Tic Tac sweet box to a three-story building (~7,000 cubic feet). This differs from many methods, he says, where effects of scaleup are estimated from one or two parameters, such as tip speed or volumetric flow rate.
“This seldom works,” he points out. “Whereas what we provide is an insight into the inner workings of the bioreactor, and how the cells are seeing different nutrient concentrations and flow rates at large and small scale.”
Skipping an intermediate step
The benefit of this approach, he continues, is that it’s possible to skip intermediate pilot phases in bioreactor scale-up as well as reducing the number of experiments needed.
“Due to a better understanding of the bioreactor processes, we don’t need to take such small steps to production size,” continues Witz, adding that due to the more accurate modeling, he believes the SimVantage software minimizes errors in scaleup.
The company is currently working with between eight and ten industrial clients in the pharmaceutical, food additive, and other sectors. According to Witz, validating the model to meet regulatory requirements is the main challenge of working with pharmaceutical clients.
“We’re working on getting simulation more accepted by the FDA and EMEA, so you can do parts of your reactor characterization on a computer at the extreme ends of the operating range,” he says.
The company is also working to add new algorithms to their models covering, for example, the behavior of large gas bubbles. They have recently added equations covering particles that can sediment to their program.