Purolite opened a new Protein A plant in Llantrisant Business Park on September 27th. Purolite says its facility will give biomanufacturers the “only credible alternative” for the supply of agarose Protein A resin.

BioProcess International reports Purolite claims its chromatography resins can reduce costs by up to 70% compared to the market leading product. The manufacturing facility is 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.

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

He said the Praesto range of Protein A resins are made by taking agarose power, extracted and milled from seaweed. He said “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.”

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.

Chris Major said “Agarose is still the gold standard bead choice for chromatography. 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…90% of processes use agarose resins.” He said the new facility now gives industry the “ability to derisk their security of supply and dual source resins.”

He said the industry will also benefit from increased innovation due to the increasing competition. He said “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 Chris Major referred to was GE Healthcare. Sofie Stille, general manager of BioProcess Downstream Resins at GE Healthcare Life Sciences, said “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.”