“The goal is to build on the earlier collaborative work to deliver a technical package characterising the requirements of making batches for clinical trials use and at a larger scale,” Puridify’s CEO Oliver Hardick told Biopharma-Reporter.
The announcement extends an evaluation of Puridify’s FibroSelect purification technology for a further 18-months after the companies demonstrated proof of concept studies at the 50L scale, with potential calculated economic benefits based on the technology’s use.
FibroSelect is University College London, UK spin-out Puridify’s tech platform consisting of a nanofibre-based material to which various ligands can be attached to activate the platform for purification at a molecular level.
Protein A, column B
In this partnership, Puridify is adding a Protein A ligand to select for monoclonal antibodies and similar therapeutic molecules such as fusion proteins.
And according to Hardick, the flexibility and potential costs of the platform will drive its adoption in industry.
“The relatively open structure of the nanofibre matrix can deliver high capacity and high flowrate, overcoming limitations often seen with packed bed chromatography purification and chromatography membranes,” he said.
“It is still the Protein A ligand that is doing all of the work, FibroSelect just presents the Protein A ligand on a surface that makes it immediately accessible and is tolerant of more challenging feeds. This enables processors to use the ligand much more effectively and carry out the unit operation in a much faster and more flexible manner.”
Capex
While still being evaluated, the tech would most likely be inserted into new processes, he continued.
“The capex considerations of introducing FibroSelect are minimal as this is a truly single-use purification technology, bringing with it many of the well-recognised benefits of switching to a single-use process.
“Capex would be lower than the traditional hardware installation for primary capture and there are opportunities with new facilities to make them simpler and less costly.”