Development of formulations of protein therapeutics is typically done using high-throughput screening of a range of buffering and stabilizing agents. This empirical process can take weeks, delaying the molecule’s entry to the clinic. Here, we describe the development of final formulation compositions for single domain antibodies (sdAbs) using an <i>in silico</i> tool that relates protein sequence, physicochemical behavior and formulation composition. We tested a constrained set of excipients based on the most common formulations found in FDA and EMA approved drugs, and determined the suitability of the formulations for a set of sdAbs by analyzing protein stability with Circular Dichroism, Intrinsic Fluorescence and Light Scattering under a range of formulation compositions. These data were used to build a tool to predict a stabilizing formulation composition, given only a protein sequence. After analyzing several sdAbs and their optimal compositions, we predict stabilizing formulation compositions for new sdAbs based only on sequence. Rapid prediction of stabilizing formulations would streamline end-to-end process development of new molecules. In the future, this tool can be extended to other classes of products, beyond single domain antibodies.

Prediction of stabilizing formulations for single domain antibodies

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.