Proteins

Abstract The aim of this study was to assess to what extent a simulated trehalose monolayer can predict the minimum...

Abstract Protein-based therapeutics at high-concentrations often face significant development challenges, including high viscosity, limited solubility, poor injectability, and instability concerns....

Regulatory support for New Approach Methodologies is growing rapidly. For excipients, however, acceptance remains largely case-specific and linked to the...

Abstract The permeation enhancers (PEs) sodium salcaprozate (SNAC) and sodium decanoate (C10) are reported to enhance gastric and intestinal absorption...

Abstract Lysine (Lys) is a nutritionally essential amino acid with a well-established parenteral safety record, yet its potential as a...

Abstract To facilitate the development of protein depots for sustained delivery, this study optimized spray-dried formulations of a model antibody...

Abstract Inhaled biologics to treat lung diseases have an extensive history. This is counterbalanced by the limited products that have...

Abstract Therapeutic proteins have emerged as a cornerstone of modern medicine due to their high specificity and strong biological effects....

Abstract Mucopolysaccharidosis type I (MPS-I) is a rare, multisystemic lysosomal storage disease (LSD) caused by mutations in the IDUA gene, which encodes...

Abstract Oxidation represents a key pathway for the chemical degradation of therapeutic monoclonal antibodies (mAbs), and chemical liabilities such as...