The formation of foam in bioreactors, an inevitable result of the agitation needed to aerate and suspend cells, significantly impacts on efficacy, affecting everything from nutrient circulation to downstream processing.
This efficiency loss has created demand for methods to minimize foam formation but, while numerous antifoam products are available, Ex-Cell has unique characteristics that SAFC spokesman Bruce Lehr believes will generate a “strong market response.”
Key among these, Lehr told in-PharmaTechnologist, is an assay that allows users to determine the concentration of Ex-Cell’s key anti-foaming ingredient, simethicone, to ensure it is within the specified 0.7 to 1.5 per cent range.
This, he continued, allows biomanufacturers to calculate the precise amount of Ex-Cell to add to bioreactors to create a consistent, reproducible antifoaming effect in accordance with quality-by-design (QbD) principles.
Lehr added that, because simethicone can interfere with downstream processing, the ability to know the precise quantity in the system can further improve efficiency.
“A certain amount of interference is expected, however the degree of interference can be minimized when a client knows exactly how much to add. Consistency and predictability are key value drivers that are addressed by EX-CELL Antifoam.”
He went on to say that the product is already used in the production of one bio-molecule in Phase III clinical trials and is being evaluated in the production of another, but was unable provide further details for reasons of customer confidentiality.