The firm launched MabSelect PrismA at Biotech Week Boston today, and believes the improved efficiency of the resin will make it the preferred option among its biopharma customers in the capture of monoclonal antibodies.
“MabSelect PrismA uses a new Protein A ligand and a new agarose bead, which have been co-optimized to achieve very high dynamic binding capacities (DBC),” GE’s business leader for its chromatography resin portfolio, Jonathan Royce told Biopharma-Reporter.
“Our development work showed that it is the unique combination of the ligand and the base matrix that enable this level of performance.”
Compared with GE’s current MabSelect SuRe LX Protein A offering, MabSelect PrismA can improve monoclonal antibody capture by as much as 40%, the firm said, and it is also more alkaline-stable, meaning it can be cleaned with a higher concentration of sodium hydroxide to better control 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,” Royce said.
“However, other variants of MabSelect will continue to be important parts of our portfolio, especially when they are already used in late-stage clinical and approved manufacturing processes.”
The ligand itself is made by GE at its facility in Uppsala, Sweden, though an external second supplier “gives added security of supply” to customers, though Royce did not disclose the identity of the contract manufacturer.
GE's long-term ligand supplier Repligen is not the contract manufacturer for this new offering, Repligen CEO Tony Hunt told Biopharma-Reporter and an extended ligand supply deal signed last year still stands.
With its undeniable efficacy in downstream processing, Protein A is seen as the gold-standard in monoclonal antibody capture. It also comes with a price tag as high as $12,000 per litre, accounting for as much as 30% of the total cost of making a monoclonal antibody.
“Protein A purification can appear expensive compared to many other purification methods, because the ligands in Protein A are recombinant proteins and complex to produce,” Royce explained.
“However, Protein A is a very effective and a simple method to use, so when looking at the total cost of technology and process, the high yields and reduced time-to-market make it rather cost-effective.
“The industry has been using protein A for decades, and its specificity and robustness is difficult to surpass. During the past fifty years, scientists have been developing Protein A purification even further, and we believe that it will continue to have a dominant role for a very long time.”
As for GE’s latest offering, Royce said the price is yet to be finalised but is expected to offer “excellent, overall process economy for our customers through its significantly higher binding capacity and alkaline stability enabling large productivity gains in new manufacturing processes.”