APA 2023 -- A study assessing the feasibility of performing quantitative analysis of Pembrolizumab in human whole blood collected using Mitra� (Neoteryx) volumetric adsorptive microsampling (VAMS) devices was conducted.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q14 is a new quality document describing analytical procedure development. Previously, no ICH guidance specifically covered analytical method development, resulting in a lack of clarity on what to present to regulators.

The underlying principle for biopharmaceutical development and manufacturing is to provide a drug product that is both safe and efficacious for the patient. Therefore, manufacturing of any drug substance and drug product must demonstrate consistent production of a quality product, which must be shown to be stable over its intended shelf life.

BEBPA EUR Bioassay 2023 -- RNA vaccines, comprising a mRNA encapsulated in a lipid nanoparticle (LNP), are a new modality for rapid development of synthetic prophylactic and therapeutic vaccines.