A biomanufacturing consultant believes that engineering insights can help companies move successfully to large-scale manufacturing. Joachim Schulze, PhD, CTO of the Planetary Group, is due to speak at the Bioprocessing Summit Europe next month about an engineering perspective on scaling-up new technologies.
According to Schulze, engineering perspectives on cutting costs in the price-sensitive cosmetics and food industries could also be beneficial to the pharmaceutical industry. As he told GEN, “It should apply, but it doesn’t.”
Some emerging therapies, such as CAR-T, typically cost from $500,000 to $1,000,000 to treat a single patient, with production a significant factor in the cost.
In an exclusive interview, Schulze explained that many methods that work in the laboratory fail at the industrial scale, wasting time and money. One example might be trying to extract a product from yeast or fungi using glass beads in a mill, a laboratory process that isn’t translatable to a larger scale.
“From the beginning, even on the benchtop you need to think about scale up, or you waste time on detours,” he says. “The engineer’s perspective is always thinking from the end.”
When consulting with new companies, he performs a techno-economic analysis as early as possible, sometimes even when the product is still in the laboratory. He aims to find inefficiencies that become prohibitively expensive as the product scales up.
An example is adding expensive nutrients during a fermentation, or the addition of calcium or magnesium compounds that require an industrial bioreactor to be made of specialist alloys. Schulze also talks about how a stir tank bioreactor might have appropriate power consumption at a small scale, but the stirrer could become destructively powerful or expensive at larger volumes.
Talking further to GEN, he explained that many of these factors aren’t typically accounted for in pharmaceutical manufacturing—where costs can remain much higher than in food or cosmetic production. But, he says, they probably should be, especially for products like biosimilars, which need to be cheaper than the branded drug.
