Solventum, the recent healthcare spinoff of 3M, is expanding the range of applications for its fibrous chromatography material. The company hopes to offer the 3M™ Harvest RC Chromatographic Clarifier, launched in 2021, for chromatography applications including AAV manufacturing.
“I’m quite excited about the future because we’ve only just started scratching the surface of this technology platform,” says Masa Nakamura, PhD, bioprocess science senior specialist at Solventum.
The technology was launched as an alternative to centrifugation or filtration, according to Nakamura, who will be discussing how it can help with process intensification and simplification at the BioProcess International Conference in Boston later this month.
“We see a big gap in the industry as people still do clarification using the same technical principles as for the last thirty years,” he explains. “Resins and bioreactors have both improved, while clarification technologies have fallen behind.”
Improving bioprocess efficiency
The Harvest RC Chromatographic Clarifier aims to improve the efficiency of bioprocessing by using a charged material to remove cells and debris in a single clarification step.
“If the clarification step is more efficient, you have a better-quality output and downstream processing can become more efficient, as well,” continues Nakamura.
According to Solventum, the fibrous material is made by grafting positively charged polymer ligands to the surface of nonwoven synthetic polypropylene fibers. The material, which has an open structure like a net, works a bit like an N95 mask to gently capture cells.
As it’s a new type of material, the surface grafting and chemistries can be changed to deal with different processes, such as the messy soup of cells and debris produced during intensified manufacturing, he explains.
Unlike filtration with natural materials, the synthetic fiber produces consistent quality for each batch, he says. And, unlike centrifugation, it can be used at a variety of manufacturing scales.
“During drug discovery, companies often use filtration, but then need to reoptimize their processes once they move to centrifugation in a big facility,” he notes. “Using the same technology, with the same high-quality result, even at development scale, reduces that gap in efficiency.”
Nakamura says he’s now thinking about the potential to change the chemistry, charge, and spacing of the fibers to open the clarification technology to new applications.
“We’ve already shown we can handle CHO cells,” he points out. “Thus, all other cell therapy products also might be applicable based on this chromatographic approach.”
