Purolite says its 100,000 L facility will give biomanufacturers the “only credible alternative” for the supply of agarose Protein A resin. The firm claims its chromatography resins can reduce costs by up to 70% compared to the market leading product.

This week, Purolite Life Sciences cut the ribbon at a manufacturing facility in Llantrisant Business Park, Wales capable of producing 100,000L of its Praesto range of agarose Protein A affinity resins.

Supported by a Welsh government grant, the facility is expected to provide 30% of the world’s agarose demand and offer biologic makers security of supply in its raw materials.

Purolite cut the ribbon on its 100,000 L facility on September 27 2018

“Primarily [the new facility] was driven by the expected growth in chromatography resins in the coming years,” Chris Major, Global Sales & Marketing director for Agarose Life Sciences at Purolite Corporation, told BioProcess Insider.

“However, we have an increasing demand for our Praesto line of agarose products, in line with the desire from the industry for alternative suppliers of agarose chromatography resins.”

The Praesto range of Protein A resins are made by taking agarose power, extracted and milled from seaweed he explained. “We then use a solvent to create porous beads. Around 90-95% of the bead is actually water, the rest is agarose. Once we have the bead we attach or couple the Protein A ligand to the beads.”

Gold standard

Protein A is used in large-scale purification of monoclonal antibodies (MAbs). However it comes at a cost, accounting for a large portion of the overall raw material costs to MAb processes.

“Agarose is still the gold standard bead choice for chromatography,” Major said. “It is extremely well known by the regulators, very hydrophilic meaning less non- specific binding, easy to handle and pack in to columns, and is very stable at high sodium hydroxide concentrations.”

The ribbon was cut by Rt Hon Carwyn Jones – First Minister of Wales

“90% of processes use agarose resins,” he continued, adding that the new facility now gives industry the “ability to derisk their security of supply and dual source resins.”

The industry will also benefit from increased innovation due to the increasing competition, Major added.

“Before Purolite entered the market place several years ago, there was only one provider of agarose Protein A resins with close to 95% market share. Today Purolite is the only credible alternative.

“Just two years ago, our capacity was 40g/l but we have pushed the boundaries to 80+g/l, essentially doubling capacity. Our resins provide unmatched performance, manufactured at the highest possible quality standards with a significant reduction on cost, up to 70% when compared to the market leading resin.”

The sole provider of agarose Protein A resins Major referred to was GE Healthcare. When contacted for a response to his comments, Sofie Stille, general manager of BioProcess Downstream Resins at GE Healthcare Life Sciences told us:

“We continue to invest in innovation to provide high productivity resins as well as capacity to ensure security of supply. We have a strong dedication to support the biopharma industry and patients around the world and for this we make significant contributions.”