Formulation Technology Increases Protein Stability

Aegis Therapeutics (San Diego, CA, www.aegisthera.com) has launched a new formulation technology to increase the stability of proteins and peptides.

Edward T. Maggio, PhD, CEO of Aegis Therapeutics, told Pharmaceutical Technology that the company’s “ProTek” nontoxic, inert excipients can be added to a protein or peptide solution during purification and concentration to reduce or eliminate aggregation, which could occur during manufacturing processes when peptides and proteins are manipulated at high concentrations.

“Proteins and peptides like to aggregate,” he says. “In some cases, it’s not a problem at all, but in other cases it gives rise to immunogenicity or loss of activity. As they aggregate, their absorption into systemic circulation decreases.” With certain formulations, unwanted immunogenicity could cause serious adverse effects or even death.

Aggregation also could occur during extended storage, which causes challenges for cold-chain management of products such as insulin injections. “There are no room-temperature insulins right now. There are issues with denaturization and loss of activity,” notes Maggio. “We think insulin could be an exciting application for ProTek.” The company also has studied the possibility of using its technology to stabilize human growth hormones as well as a nasal-administered anti-HIV peptide that reduces viral levels and flushes active virals from monocytes.

The technology is suitable for aqueous or lyophilized dosage forms that are delivered through injectable, intranasal, pulmonary, oral or other transmucosal routes.