The $3m (€2.7m) investment has expanded the life sciences’s pilot plant in Llantrisant, UK, taking annual capacity for its Protein A affinity media Praesto to 3,000 L.
Praesto is manufactured using protein A ligands supplied by Repligen and agarose, a seaweed-derived polymer, which Purolite spokesman Chris Major told us is a material well understood and accepted by the regulatory authorities and is considered the “gold standard” in Protein A resin.
This leads to a resin which is “easy to pack reducing downtime, provides long life time due to tolerance under alkaline conditions which in turn maximises cost of goods,” he said, adding its “low matrix volume provides high capacity which reduces the size of process operations.”
The new pilot plant is fully validated and commissioned and today is producing resins to full fill customer orders. A third phase expansion is scheduled to begin later this year, ahead of a 100,000L agarose commercial manufacturing facility coming on line in 2017.
Cutting the cost of chromatography
Protein A media’s high efficacy in capturing monoclonal antibodies during the downstream chromatography process means demand is high for the product, as biopharma firms increasingly turn to mAbs.
However, the resin is also regarded as the most expensive key raw material in processing mAbs, partly due to a lack of competition among vendors, according to Major, who told us “customers are frustrated with the very high price.”
For the agarose-derived resin market, GE Healthcare – which recently extended its own Protein A ligand supply deal with Repligen - holds a near monopoly, he continued.
“Purolite is the first realistic alternative to GE’s resins and by using advanced manufacturing technology we have streamlined our production to maximise efficiencies and provide the best agarose resins together with a significantly lower cost of goods.”
The firm, which has been manufacturing resins for over 35 years, took just 18 months to develop the Praesto resin, he said, and is working with column manufactures to ensure compatibility.