GMP production of pharmaceutical nanoparticles
Dr. Emre Türeli, MJR PharmJet GmbH, Überherrn, Germany
Do, 17.05.18, 16:00 room 1.001 of the Max Planck Institute for Polymer Research
As nanoparticles’ efficacy depends on their average size, size distribution, surface charge and surface chemistry, in the scale-up process these pre-clinical optimal parameters should be preserved. However, most of the nanoparticle manufacturing methods are not easy to implement in existing manufacturing plants and the characterization methods are not yet standardized and not easy to establish.
To ensure industrial sustainability, starting from the early phases of the pharmaceutical development chain, translation of manufacturing and characterization methods should be an important aspect. Considering that the batch sizes that are realized during the development and pre-clinical characterization phases are most of the time not applicable to the demands of the industrial manufacturing process, it wouldn’t be wrong to label the scale-up of developed manufacturing methods as the first translational challenge of the hard route from bench to bedside. Scale up possibilities include conventional technologies (i.e. high pressure homogenization, batch processes in existing reactors/mixers) or innovative technologies (i.e. micro-channel reactors), micro mixers and continuous mixers.
In recent years, nanotechnology has turned out an intriguing tool to solve some of the unmet needs in the pharmaceutical industry. However tremendous efforts are still required to fill the gap between research labs and the market, and sustain translational research on nanotechnology products with clinical potential. Market penetration success of a pharmaceutical nanotechnology product is dictated by its successful development through careful design of processes starting from the very early stages of research, its applicability to GMP and its compliance with regulation policies.