Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, guided by regulatory frameworks like FDA and ICH. Technological advances, ...

Aseptic processing improvements aim to reduce contamination from operators, yet interventions remain necessary, increasing contamination risk. 'Inherent' and 'corrective' interventions are ...

To assure patient safety, biologics developers and manufacturers must carefully consider where contaminants could be introduced to the drug substances (DSs) or drug products (DPs) at all stages of the ...

This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...

Today’s market demand on biologic and pharmaceutical manufacturers to develop new drugs - combined with the economic environment - is challenging bio-processors to review their processing systems and ...

Traditionally, vaccine manufacture has accounted for a huge amount of aseptic production. In recent years, there has been a larger focus on novel biologic therapies, of which the majority are ...

Dublin, July 28, 2025 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" has been added to ResearchAndMarkets.com ...

The latest improvements in aseptic blow-fill-seal technology are providing more streamlined automation of critical B/F/S processing areas, while limiting human intervention and effectively reducing ...