null Quality requirements for nanomedicines: what role should the European Pharmacopoeia play?

EUROPEAN PHARMACOPOEIA 7-8/06/2022 PDF Presentation

The COVID-19 pandemic and the emergence of mRNA vaccines have highlighted the importance of nanoparticle formulations - especially lipid-based systems - used for nucleic acid-based APIs. The success of SARS-CoV-2 vaccination programmes across the globe has demonstrated that these nanoparticle-based formulations can be used to produce safe and efficacious medicinal products.

Seen as part of a broader trend, modern formulations using nanoparticle systems (e.g. liposomes) have long been the focus of pharmaceutical research, and we are beginning to see the fruits of this with the emergence of new medicinal products based on these formulations. Consequently, attention is turning increasingly to issues surrounding the creation and implementation of standards for medicinal products using liposomes or other nanoparticle-based preparations.

The aim of this event is to identify any gaps and opportunities for standards concerning modern nanoparticle-based formulations which can be filled by the European Pharmacopoeia (Ph. Eur.), notably by setting common quality standards across Europe and beyond. This has particular relevance in the context of the COVID-19 pandemic.

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Target audience

This event is of interest to vaccine manufacturers, pharmaceutical manufacturers from other fields using nanotechnologies, specialist suppliers (including providers of raw materials), representatives from national and international regulatory bodies as well as scientists involved in the quality control of nanomedicines.

 

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