Injectable protein medications are lifesaving therapies for patients with cancer and autoimmune diseases. However, developing stable, concentrated protein therapies can be challenging due to regulations requiring small volumes and viscosities. Accordingly, many therapies are administered intravenously at hospitals, requiring long, expensive stays. Developing ultra-concentrated (>150 mg/mL) medications that can be self-administered subcutaneously can reduce costs and improve flexibility for patients. However, ultra-concentrated formulations often suffer from high viscosities and poor stability at rest and under flow.
In the December AIChE Journal article, “Polysorbate Identity and Quantity Dictate the Extensional Flow Properties of Protein-Excipient Solutions,” Michelle Calabrese (Univ. of Minnesota) and her coauthors study ultra-concentrated protein and excipient solutions in extensional flows.
Proteins can denature and lose efficacy when injected due to strong extensional forces, which are more detrimental to protein structure and function than shear forces. Further, pharmaceutical excipients — i.e., molecules like polymers or surfactants that are added to reduce shear viscosity and stabilize formulations — can cause...
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