Synthetic MAb purification tech edges closer to market

ProMetic BioSciences this week announced that its MAbsorbent ligands, used for the purification of monoclonal antibodies (MAbs) and recombinant antibody fragments, had successfully met pre-set performance targets that make them real contenders in the MAb purification market.

ProMetic's purification products are synthetic chemical entities, unlike biological ligands commonly used in traditional protein purification techniques.

The performance of the synthetic ligands was confirmed by seven leading antibody producers, all of whom existing ProMetic clients.

Biological ligands, such as those based on immobilised protein A, are widely used in MAb purification, but are expensive to produce and offer limited operational lifetimes.

ProMetic claims that its synthetic alternative can offer a more cost-effective and robust option for MAb producers, who are coming under increased pressure to up production in anticipation of growing demand from the blossoming biopharmaceutical industry.

" Current products are based on protein ligands ," explained ProMetic BioSciences' head of R&D, Dev Baines.

"Until now there has been no platform technology for purification of monoclonal antibodies."

The MAbsorbent ligands offer improvements in stability and cost-effectiveness, according to the company - a significant plus-point when a litre of a biological ligand such as protein A can cost as much as $10,000 (€7,300).

The products developed by ProMetic were selected following extensive research based on commercially used materials in the biopharma industry - " it wasn't blue skies research ," said Baines.

An important point made by the company is that a growing number of monoclonal antibody products are in fact antibody fragments (as opposed to full chain antibodies).

These can be tricky to purify as they lack the region to which protein A binds (the Fc region), making this standard purification technique unusable.

Prometic has tackled this problem by developing a new synthetic ligand that binds to a different region of the antibody molecule, providing an effective solution for the capture and purification of antibody fragments.

This is one of the newest additions to the MAbsorbent range, which comprises two products used primarily for the capture and purification of polyclonal antibodies from plasma, and another which binds to the Fc region to provide high antibody recoveries and dynamic capacities in excess of 30g/litre.

The success of the new ligands is a key achievement for the company, as it can now scale up manufacturing and penetrate the growing MAb purification market, currently worth an estimated $16bn.

The ligands will be manufactured at the company's newly renovated production facility on the Isle of Man, with products hoped to hit the market by the end of this year.

According to ProMetic, the company will be tapping into a rich revenue stream, fuelled by concerns within the biopharmaceutical industry that manufacturing outputs and improvements in process yields are unable to keep up with the increasing demand for MAbs for therapeutic applications.

Following the successful development of its ligand products, the next stage for the company is to move on with manufacturing scale-up and preparations for market launch.

"There is a critical need for these type of products," said Baines.

"We hope to make a substantial in-road into the market."