Excipients in lipid nanoparticles (LNP) can enhance the drug absorption or delivery and are thus of high interest in various therapeutic fields. However, the unique characteristics also pose regulatory challenges and exceed the authority’s expectations on data compared to other excipients. The purity and safety need to be demonstrated because of their crucial role in the function of the drug product and complex potential interactions with other ingredients or the physicochemical environment, for example. Thus, an overview of the regulatory excipient classification and the associated emerging regulatory challenges are presented for LNP, liposomes, and novel excipients.
In this webinar, you will learn about:
- The regulatory classification of excipients
- Purity and safety assessment of excipients for use in lipid nanoparticles
- Specific and current regulatory requirements for lipid nanoparticles, liposomes, and novel excipients
- Emerging regulatory challenges
Speaker
Claudia Widmann, Ph.D.
Merck
Regulatory Expert
Claudia Widmann is a regulatory expert in our pharma registration group. Her main activities include dossier creation and maintenance for products developed at the corresponding location in Switzerland. The product manufacturing is specialized among other products in lipid excipients. Claudia holds an M.S. in regulatory affairs from the Technische Universität Lübeck, as well as an M.S. and Ph.D. in a nanotechnological field of expertise.
Pharma and biopharma manufacturing
- Liquid Formulation Strategies
Duração:38min
Idioma:English
Sessão 1:apresentado November 4, 2021
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