The growing need for biologics to be administered subcutaneously and ocularly, coupled
with certain indications requiring high doses, has resulted in an increase in drug substance …

Three critical aspects that define high concentration antibody products (HCAPs) are as
follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration …

Nano differential scanning fluorimetry (nanoDSF) is a high-throughput protein stability
screening technique that simultaneously monitors protein unfolding and aggregation …

Monoclonal antibodies (mAbs) are particularly relevant for therapeutics due to their high
specificity and versatility, and mAb-based drugs are hence used to treat numerous diseases …

Innovative therapies to complement current treatments are needed to curb the growing
incidence of fatal overdoses related to synthetic opioids. Murine and chimeric monoclonal …

Multiple advanced formulations and drug delivery systems (DDSs) have been developed to
deliver protein-based biotherapeutics via the subcutaneous (SC) route. These …

The viscosity of a monoclonal antibody solution must be monitored and controlled as it can
adversely affect product processing, packaging and administration. Engineering low …

Administration of monoclonal antibodies (mAbs) is currently focused on subcutaneous
injection associated with increased patient adherence and reduced treatment cost, leading …

In recent decades, subcutaneous (SC) administration of monoclonal antibodies (mAbs) has
emerged as a promising alternative to intravenous delivery in oncology, offering comparable …

Understanding the effects of additives on therapeutic protein stability is of paramount
importance for obtaining stable formulations. In this work, we apply several high-and …