Hoping to hurry up scaleup via detailed modeling of bioreactors, SimVantage, which was based in December 2021, is working with pharmaceutical firms to assist them scale up their bioreactors from laboratory to industrial scale.
“We’ve created a digital copy of a bioreactor to assist with course of switch and troubleshooting,” explains Christian Witz, PhD, the corporate’s founder and CEO, who spoke concerning the expertise at BioProduction in November final 12 months. “The purpose is to cut back experimental load and, thus, time taken for a full scaleup.”
SimVantage started ten years in the past as a university-industry collaboration to mannequin large-scale bioreactors. “A pharma firm went to the simulation firms present at the moment and requested them to simulate a large-scale bioreactor. Nobody may try this, so that they got here to the college and requested us,” Witz.
The software program is exclusive, he claims, as a result of it simulates bioreactors from bodily first ideas. This implies, he says, the identical mannequin can be utilized for bioreactors ranging in measurement from a Tic Tac candy field to a three-story constructing (~7,000 cubic ft). This differs from many strategies, he says, the place results of scaleup are estimated from one or two parameters, equivalent to tip pace or volumetric stream price.
“This seldom works,” he factors out. “Whereas what we offer is an perception into the inside workings of the bioreactor, and the way the cells are seeing completely different nutrient concentrations and stream charges at giant and small scale.”
Skipping an intermediate step
The advantage of this method, he continues, is that it’s doable to skip intermediate pilot phases in bioreactor scale-up in addition to lowering the variety of experiments wanted.
“Resulting from a greater understanding of the bioreactor processes, we don’t must take such small steps to manufacturing measurement,” continues Witz, including that as a result of extra correct modeling, he believes the SimVantage software program minimizes errors in scaleup.
The corporate is at the moment working with between eight and ten industrial purchasers within the pharmaceutical, meals additive, and different sectors. In response to Witz, validating the mannequin to fulfill regulatory necessities is the primary problem of working with pharmaceutical purchasers.
“We’re engaged on getting simulation extra accepted by the FDA and EMEA, so you are able to do components of your reactor characterization on a pc on the excessive ends of the working vary,” he says.
The corporate can also be working so as to add new algorithms to their fashions overlaying, for instance, the conduct of enormous gasoline bubbles. They’ve just lately added equations overlaying particles that may sediment to their program.
