Protein A: expensive but effective say biopharma experts on both sides of the Atlantic

By Gareth Macdonald contact

- Last updated on GMT

Protein A: expensive but effective say biopharma experts

Related tags: Biotechnology, Monoclonal antibodies

Protein A will continue to be a major cost for mAb manufacturers despite efforts to develop alternatives say experts.

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 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​.”

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