The Development of a Sustained and Controlled Release Device for Pharmaceutical Proteins based on Lipid Implants

The use of synthetic, biodegradable polymers is prevalently
considered state-of-the-art in the development of controlled
release systems for protein drugs. However, unveiled risks of
protein inactivation during manufacturing and release represent a
bottleneck in the final success of these systems over the last
years. In this thesis, a sustained release implant device based on
lipid materials for interferon alpha-2a (IFN alpha-2a) was
developed, which provides high protein stability during implant
preparation, storage, and drug release. Thus, the known problems of
immune response associated with higher-order aggregate formation in
proteinic drugs can be overcome. Adjustment of the lyophilisate
formulation as well as of PEG and lipid qualities and quantities
allow to control the release rate in order to realise the dosing
schedule aimed for. Consequently, this device can be used as a very
promising platform to deliver large pharmaceutical proteins for
periods up to 1 month and even beyond.