Quality Requirements for Nanomedicines: Filling the Gaps

Nanopharmaceuticals are playing an increasingly important role in drug research and development. They open up interesting therapeutic perspectives via increasing efficacy or optimizing tolerability. Nanotechnology is therefore considered to be one of the key technologies for innovative medicines that can be used to overcome previously unsolved or unsatisfactorily resolved therapeutic challenges.

Currently, more than 70 nanotechnology-based medicinal products have already been approved, which includes also e.g., the m-RNA-based COVID-19 vaccines. Nanotechnology is used in medicine to transport active ingredients to their sites of action in a targeted manner, to increase bioavailability and to improve efficacy as well as safety profiles.

The essential goal of this project, funded by the Frankfurt Foundation Quality of Medicines (FFQM), is to identify and, where possible, close methodological gaps in the characterization of nanomedicines and to provide proper data analysis to support quality requirements for nanomedicines. The project is designed and conducted by Dr. Ines Nikolic, postdoctoral researcher with Prof. Gerrit Borchard at the University of Geneva, and in collaboration with Swiss Federal Laboratories for Materials (EMPA) Science and Technology and University of Belgrade – Faculty of Pharmacy.

In this grant project, selected pharmaceutical nanosystems will be investigated with the aim of characterizing them based on key parameters relevant to pharmaceutical and therapeutic quality. In the case of nanopharmaceuticals, these include the size and shape of the particles as well as their surface functions, the efficiency of drug encapsulation and the release kinetics. Accordingly, the objectives of the project are:

1. the selection and testing of methods that can be used to obtain information on particle size and surface properties
2. the evaluation of particle modifications in their biorelevant environment and estimation of sample stability in corresponding media
3. the study of in-vitro toxicology and in-vitro immunology of nanosystems with the aim to find out how variations of particles can trigger biological responses
4. the integration of physicochemical and biological data sets with the aim of supporting future projects in research and development of nanomedicines and, above all, for regulatory authorities to facilitate the quality and safety assessment of these products.

The Frankfurt Foundation Quality of Medicines is waiting with great interest for the first results of this important research project.