Biologics are expected to expand their pharmaceutical pipeline, as they offer targeted treatment options for a wide range of diseases. However, maintaining the biomolecules’ stability throughout process development is a known challenge. Thus, providing meaningful understanding of these complex biomolecules through fast and reliable data becomes increasingly crucial, as it paves the way for the success of every biotherapeutic.

In a collaborative work between Hovione R&D and IST - Instituto Superior Técnico - “HOT N COLD formulation of biologics for the optimization of drying technologies” - with the aim of evaluating the impact of different excipients on protein stability during freeze-drying (FD) and spray drying (SD) processes, the use of lysozyme as a model molecule allowed us to understand the interplay of a wide range of excipients in maintaining protein activity and stability during processing, forecasting scalable drug development.