Spray drying presents numerous advantages over other drying technologies, particularly for
inhaled biologics because of the fine-tuned particle attributes requirements. To fully …

Biopharmaceuticals commonly require freezing to ensure the stability of the active
pharmaceutical ingredients (APIs). At commercial scale, freezing is typically carried out over …

Despite its importance to multiple scientific fields and industries, the freezing process of
aqueous solutions is not yet completely understood. In particular, the relationship between …

Biopharmaceutical formulations may be compromised by freezing, which has been
attributed to protein conformational changes at a low temperature, and adsorption to ice …

Freezing processes are a well‐established unit operation in the biopharmaceutical industry
to increase the shelf‐life of protein‐based drugs. While freezing reduces degradation …

Purpose Small-scale models that simulate large-scale freezing of bulk drug substance of
biopharmaceuticals are highly needed to define freezing and formulation parameters based …

There is a need for representative small volume devices that reflect monoclonal antibody
(mAb) aggregation during freezing and thawing (FT) in large containers. We characterised …

Purpose Scale-down devices (SDD) are designed to simulate large-scale thawing of protein
drug substance, but require only a fraction of the material. To evaluate the performance of a …

Freezing of cell culture supernatant (CCS) is a standard procedure in process development
of monoclonal antibody (mAb) platform processes as up‐and downstream development are …

Purpose Large-scale freezing and thawing experiments of monoclonal antibody (mAb)
solutions are time and material consuming. Computational Fluid Dynamic (CFD) modeling of …