GE Healthcare said today it is launching a new protein A chromatography resin and will spend $70 million a year over each of the next five years to produce it.
MabSelect PrismA is an affinity BioProcess™-branded chromatography resin for capturing monoclonal antibodies (mAbs) and Fc-containing recombinant proteins. MabSelect PrismA is designed to enable biopharma manufacturers to improve their mAb purification capacity by up to 40% over GE Healthcare’s existing protein A affinity medium MabSelect SuRe LX, the company said.
MabSelect PrismA is also “significantly” more alkaline-stable than MabSelect SuRe LX, GE Healthcare added, due to a protein A–derived ligand that allows the use of a higher-concentration 0.5 to 1.0 M sodium hydroxide for Cleaning-In-Place (CIP), with the goal of better controlling cross-contamination and bioburden risks.
“We believe that the improved product performance of MabSelect PrismA will make it the preferred option among our MabSelect Product family products for most new process development and clinical manufacturing projects for our customers. However, other variants of MabSelect, including MabSelect SuRe LX™, will continue to be important parts of our portfolio, especially when they are already used in late-stage clinical and approved manufacturing processes,” Jonathan Royce, business leader for the chromatography resin portfolio, GE Healthcare Life Sciences, told GEN.
Royce added that GE Healthcare's policy for for discontinuation of BioProcess chromatography resins and single-use products commits the company to continuing supplies of each of its BioProcess bulk chromatography resins, single-use products, and process-scale filtration products as long as any such products are knowingly used in an approved, registered process for the manufacturing of biopharmaceuticals.
According to GE Healthcare, MabSelect PrismA yields greater efficiency due to its binding capacity, requiring less resin to purify a given quantity of protein—and making it suitable for high-titer antibody processes. The resin offers high ligand stability that reduces ligand leakage, as well as what it terms as a simple scale-up to production-sized AxiChrom™ columns.
“With this chromatography resin, our customers will be able to produce more biopharmaceuticals out of their existing manufacturing equipment. Protein purification is no longer a bottleneck, but driving higher productivity and shorter manufacturing lead times for our customers,” Jan Makela, general manager, BioProcess, GE Healthcare Life Sciences, said in a statement.
GE Healthcare said customers can order MAbSelect PrismA samples as of today, with product to be made fully available for orders during the first half of 2018.
MabSelect PrismA will be produced at GE Healthcare Life Sciences’ site in Uppsala, Sweden, where the resin was developed. GE has committed to spending $70 million each year between 2017 and 2022 to “significantly” increase the capacity of the GE Healthcare Life Sciences facility in Uppsala, the company said, without quantifying the increase.
As of last year, GE’s Uppsala site produced 30 tons of chromatography media annually from production of 270 products, generating $800M in revenue, according to a March 11, 2016, investor presentation.
The company is Uppsala’s largest private employer, with about 1200 employees, of which about 400 hold R&D positions.
GE Healthcare generated $4.7 billion in revenues during the first six months of 2017, up 4.7% from January–June 2016. Life sciences accounted for $4 billion of GE Healthcare’s $18.291 billion in revenue during 2016, up 4% from 2015.