Aegis gets patent for peroxide-free stability excipient in MAb formulations

Aegis Therapeutics has been granted a US patent for a novel formulation method and excipient that it claims reduces the risk of oxidative damage during MAb production and storage.

The new patent covers the use of ProTek – Aegis’ range of alkylglycoside excipients – as replacements for polysorbate derived stabilisation agents in formulations of monoclonal antibody-based (MAb) pharmaceuticals.

Company CEO Edward Maggio told in-Pharmatechnologist.com that while traditional surfactants like tween 20 and 80 may be widely used in MAb formulations to prevent protein aggregation they have a number of problems.

“All polysorbate-based excipients can cause damage to proteins due to the presence of reactive ether linkages and unsaturated alkyl chains that can form protein-damaging peroxides in solution.”

“Such damage” he continued “can include degradation of the therapeutic agent that renders them immunogenic, promote aggregation and dramatically reduce their shelf life.”

In contrast alkylglycosides - which are sugar units linked to the hydroxyl group of a fatty alcohol – lack either ether linkages or the unsaturated alkyl chains that can generate peroxides and, as a result, are stable and safe according to Maggio.

There is also some evidence to suggest that alkylglycoside-based excipients may be better at preventing aggregation than for polysorbate derived agents according to Maggio, although he cautioned that this is only based on a small number of assessments.

He added that more research is being conducted by Ageis’ licensees, which include Hoffman La Roche, Biodell and Johnson & Johnson (J&J).