Protein A resin is regarded as having the highest efficacy for capturing monoclonal antibodies among chromatography media. It is also expensive, costing as much as $12,000 per litre.
This is because Protein A is a recombinant protein manufactured in a similar way to an actual biological product: in a GMP or GMP-like facility, with processing steps including fermentation, harvest and purification of the ligand.
Purolite plant to challenge GE
But the cost for the end-user is set to drop, according to Chris Major, Sales Director at Welsh firm Purolite whose agarose resin, Praesto, is made using a seaweed derived polymer and Protein A ligands supplied by Repligen.
The firm recently expanded a pilot plant and this week announced it is investing in a new commercial Protein A plant in Llantrisant, UK with the capacity to produce 100,000L once validation is complete, around April 2017.
Major told us the market is currently dominated by GE Healthcare and accused the bioprocessing tools maker of under investing in chromatography resins, keeping prices high and innovation low.
The new plant will reverse this trend, he continued, by instantly giving Purolite 30% of GE’s global resin capacity.
“For the first time, customers now have a choice of suppliers for agarose resins and our pricing is very fair and sensible. End users will benefit immensely from future innovation, since for many years GE has under invested in chromatography due to low competition and large market share.”
GE welcomes competition
GE - whose resin also uses ligands supplied by Repligen - disputed being the sole supplier of agarose Protein A resin, with Jonathan Royce, Product Manager of Antibody Affinity Media, telling Biopharma-Reporter: “There are many suppliers on the market and we welcome competition because it drives innovation in both product design and in the total service offering for customers.
“Some of the other suppliers on the market have been supplying Protein A resin for nearly as long as GE Healthcare, and some have entered the market recently.”
Royce would not comment directly on Purolite’s capacity projections but said “the protein A market is one which requires extraordinary patience on behalf of the suppliers,” and not a short-term business.
GE doubling capacity
Furthermore, Royce said GE is making large investments in R&D to advance its Protein A offerings, on the back of increased demand from industry due to the steady increase in demand for therapeutic monoclonal antibodies.
“A BioPlan Associates market report from 2014 estimates that the total market for Protein A is on the order of $400m and growing around 15%,” he said, though would not divulge GE’s own sales figures.
“Security of supply is also top of mind for our customers and we’re making considerable investments in our production site in order to double our capacity for agarose-based resins by 2018.”