An examination of process models and model risk frameworks for pharmaceutical manufacturing.

Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes.

Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.

Within the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 technical white paper "Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents for Use in Human Infection Models" (published by hVIVO, Wellcome Trust, HIC-Vac consortium members). Where those recommendations cannot be met, regulators advise following the "Principles of GMP" until definitive guidelines are available.

Report of the European Medicines Agency Conference on RNA-Based Medicines.

RNA-based medicines have potential to treat a large variety of diseases, and research in the field is very dynamic. Proactively, The European Medicines Agency (EMA) organized a virtual conference on February 2, 2023 to promote the development of RNA-based medicines. The initiative addresses the goal of the EMA Regulatory Science Strategy to 2025 to "catalyse the integration of science and technology in medicines development.

Variability of in vivo potency assays of whole-cell pertussis, inactivated polio, and meningococcal B vaccines.

For the batch release of vaccines, potency release assays are required. Non-animal in vitro tests have numerous advantages and are preferred; however, several vaccines are still released using in vivo assays. Their major drawback is the inherent variability with its practical implications.

Directing the Selectivity of Oxygen Reduction to Water by Confining a Cu Catalyst in a Metal Organic Framework.

Electrocatalysis is to play a key role in the transition towards a sustainable chemical and energy industry and active, stable and selective redox catalysts are much needed. Porous structures such as metal organic frameworks (MOFs) are interesting materials as these may influence selectivity of chemical reactions through confinement effects. In this work, the oxygen reduction catalyst Cu-tmpa was incorporated into the NU1000 MOF.