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).