Tag: isotopes of oxygen

December 14, 2020

Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

This paper presents a rational workflow for growing enabling formulations, similar to amorphous strong dispersions, through hot-melt extrusion in lower than a yr. First, our strategy to an built-in product and course of improvement framework is described, together with state-of-the-art theoretical ideas, modeling, and experimental characterization described within the literature and developed by us. Subsequent, lab-scale extruder setups are designed (processing situations and screw design) […]

August 24, 2020

Research for Disulfide-Linked, Self-Immolating Subsequent-Technology Antibody Drug

Conjugation Site Influences Antibody-Conjugated Drug PK Assays: Case Studies for Disulfide-Linked, Self-Immolating Next-Generation Antibody Drug Conjugates   Immunoaffinity (IA) LC-MS/MS pharmacokinetic (PK) assays are widely used in the field for antibody drug conjugates (ADCs) containing peptide linkers that are enzymatically cleavable, such as MC-ValCit-PAB. Conjugate PK assay strategies for these ADCs involve cleavage with cathepsin B or papain to release and measure the antibody-conjugated drug (acDrug) concentration. However, […]