Platform technology set to transform purification in bioprocess manufacturing
London, UK - 5 December 2016 - Puridify Limited (“Puridify”), developers of novel bioprocessing purification technologies for industrial biomolecule manufacture, today announced the signing of an 18 month collaboration with GlaxoSmithKline (“GSK”) to extend the evaluation of Puridify’s FibroSelect purification technology with a view to building a package to support potential use of nanofibres in toxicology and clinical manufacture. This signing follows a previous 18 month collaboration which has seen successful demonstration of proof of concept studies at the 50L scale, with potential calculated economic benefits based on the technology’s use.
Venture backed Puridify has been on a rapid path of development and commercialisation to deliver an industry-ready technology that will allow a step-change to current downstream processing of industrial biotherapeutic manufacture. The unique high capacity (Dynamic Binding Capacities equivalent to packed beds) combined with high flowrate properties (1 second residence times) of FibroSelect enable the replacement of columns that are more than fifty times larger. The ready-to-operate units reduce validation burden, improve process robustness and increase facility flexibility.
FibroSelect simplifies chromatography to rapid and robust adsorptive depth filter type operations. This is further supported by the use of well understood materials: the cellulosic matrix can support any functionality, with evaluations focused on costly product-capture applications. Protein A FibroSelect achieved mAb purification with equivalent product Critical Quality Attributes (CQAs) at a productivity fifty times greater than Protein A resins (>500 g/L/h) using a single cartridge on standard chromatography equipment.
Using a ‘multi-cycle, single batch’ mode of operation FibroSelect units have demonstrated an ability to match process CQAs when cycled over 190 times with three minute run times. This purification throughput also offers rapid process development opportunities.
“The development of FibroSelect has focused on generating industry relevant end-user data. At the same time, we have been establishing a manufacturing basis for GMP-compliant products that are delivered pre-packed and ready-to-operate,” commented Dr Oliver Hardick, Chief Executive Officer of Puridify.
“Our single-use purification units will enable this technology to service very effectively the wider Life Sciences industry. Specifically, collaborations with biotherapeutic drug manufacturers are already proving the benefit of FibroSelect as a single-use high productivity product capture platform, suitable for existing and emergent biologic therapies.
“We are delighted that GSK are continuing to support us in such a significant manner, particularly as we approach commercial manufacture of the FibroSelect technology. This kind of industrial collaboration is critical for shaping the technology and generating data to support its market adoption.”
