Roche has licensed Aegis Therapeutics’ ProTek stabilisation technology, which uses GRAS excipients to prevent aggregation and therefore improve production of peptide and protein drugs.
The pharma industry is increasingly focused on peptide and protein therapeutics, particularly true of Roche following its acquisition of Genentech, and consequently technologies that improve their production are in demand.
Aegis believes ProTek is one such technology. The company developed it using generally regarded as safe (GRAS) excipients to help manufacturers maintain the physical stability and physiological activity of proteins and peptides while reducing immunogenicity.
This is achieved by preventing the aggregation of proteins and peptides. Aggregation can occur during the manufacturing process where peptides or proteins are manipulated at high concentrations.
Alternatively, it can arise during prolonged storage. In both cases it represents a difficult form of instability, potentially leading to numerous negative effects, and manufacturers are keen to stop it occurring.
ProTek was developed to perform this role in the manufacture of stable and homogenous lyophilised or aqueous dosage forms. The technology can be applied to numerous drug delivery forms, including injectable, intranasal, pulmonary and various transmucosal routes.
Roche using ProTek
Details of Roche’s use of ProTek have not been disclosed, although Edward Maggio, CEO of Aegis, described the big pharma as “an innovative world leader in monoclonal antibody and peptide based therapeutics”.
When ProTek was launched Aegis highlighted it as being particularly useful for insulin, human growth hormone, erythropoietin, interferon, Factor VIII and monoclonal antibody therapies.
Since then Aegis has gained more experience of working with the technology but nonetheless Maggio regards the licensing by Roche “as a significant validation” of ProTek.
Under the terms of the agreement Aegis will receive undisclosed upfront licensing fees and individual product-related and royalty payments.