In depth characterization of physicochemical critical quality attributes of a clinical drug-dendrimer conjugate
A deep and detailed understanding of drug-dendrimer conjugates key structural properties, including size, molecular weight, density and physical and chemical stability is needed to define the critical quality attributes (CQAs) that allow to control the drug product performance. The characterisation must be executed both in the formulation media and in biological matrices. This, nevertheless, is challenging on account of a very limited number of suitable, established methods for characterising the physicochemical properties of this complex drug delivery platform and for determining drug-dendrimer conjugates stability and interactions with the biological environment.
In order to fully characterise AZD0466, a drug-dendrimer conjugate currently under clinical development by AstraZeneca (AZ), a collaboration was initiated with the European Nanomedicine Characterisation Laboratory (EUNCL) to deploy a state-of-the-art multi-step approach to measure physicochemical properties. This characterisation framework was applied to two batches of AZD0466 and the corresponding dendrimer not carrying any drug, SPL-8984.
SONZINI Silvia;
CAPUTO Fanny;
MĖHN Dóra;
CALZOLAI Luigi;
BORGOS Sven Even;
HYLDBAKK Astrid;
TREACHER Kevin;
LI Weimin;
JACKMAN Mark;
MAHMOUDI Najet;
LAWRENCE Jayne;
PATTERSON Claire;
OWEN David;
ASHFORD Marianne;
AKHTAR Nadim;
2023-07-31
ELSEVIER
JRC128130
0378-5173 (online),
https://www.sciencedirect.com/science/article/pii/S0378517323003253,
https://publications.jrc.ec.europa.eu/repository/handle/JRC128130,
10.1016/j.ijpharm.2023.122905 (online),
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