The efficacy of Protein A in downstream processing and antibody capture is undeniable according to Jonathan RF Robinson from the UK National Biologics Manufacturing Centre, who told BioPharma-Reporter.com this is a mixed blessing for manufacturers.
“The high cost of producing monoclonal antibodies is down to Protein A, which is hard to produce and does not last forever” Robinson said, explaining that biopharmaceutical firms rely on key suppliers Repligen and GE Healthcare for regular restocking.
BioPharm Services managing director Andrew Sinclair was more measured about the impact Protein A has on cost, telling us that: “It depends on scale at high titres large volumes it [Protein A] becomes a dominant cost but not necessarily the largest cost component.”
So at the very least it seems clear that Protein A is an expensive, but necessary component of the mAb production process.
Protein A performance
Eric Langer, managing partner at BioPlan Associates, suggested this situation is likely to continue telling us “Protein A works well, end-users are comfortable using it and the US FDA and other regulators are comfortable using it.”
Companies’ willingness to pay as much as $12,000 for a litre of Protein A further underlines its efficacy according to Langer, who also said: “This industry segment [biomanufacturers] doesn’t like change, so inertia is a major force.”
“Alternatives would need to go through a rigid supplier and sub-supplier vetting process and this could take years, even decades.”
Alternative opportunities
Ironically, while the current high cost of Protein A may seem to be a market opportunity for researchers looking to develop disposable single-use alternatives, this may be a false impression according to Langer.
He explained that: “At $12k a liter, nobody wants to throw Protein A away, but end users will throw it away if it cost falls $2k/liter.
“The economics of Protein A are what’s driving the discussion about replacements at the moment. Once that changes novel tech innovators may have a bigger hurdle when it comes to introducing alternatives to Protein A.”