Through close cooperation with our partner, the Pharmacy of the University Hospital Erlangen, we have the opportunity to produce the nanoparticle systems according GMP (Good Manufacturing Practice) guidelines. To analyze the prepared specimens established characterization methods, such as dynamic light scattering (DLS), HPLC - UV or FTIR are used. The Pharmacy of the University Hospital Erlangen has a manufacturing authorization for investigational medicinal products according to §13 AMG for selected drugs (http://www.apotheke.uk-erlangen.de/leistungsspektrum/herstellungsbetrieb-nach-13-amg/). The available manufacturing facility complies with all relevant regulations, such as the EU GMP Guide, the GCP Regulation and the German Pharmaceutical Law.
For the upscaling of nanoparticle synthesis from the laboratory level up to the production of small batches a mini pilot reactor for GMP / FDA compliant synthesis is available at the Pharmacy. The reactor meets the current GMP requirements in all product contact parts.
The modular design facilitates the exchange of components to accommodate different synthesis requirements, such as: distillation, evaporation to any desired consistency, multi-component reactions, gas introduction, extraction, crystallization or precipitation.
The system is composed of a cover plate with a metering unit. A hand hole for the addition of starting material, an inert gas connection, an opening for a stirrer, a reflux condenser, and a pressure gauge for monitoring the pressure are fixed. This allows a small-stage parameterization process for the adaption of synthesis steps from the laboratory scale to larger scale under quality-controlled conditions.
phone: +49 9131/85-39041
Dr. sc. hum. Tobias Borst
Forschungsstiftung Medizin at the Universitätsklinikum Erlangen
IBAN: DE 69 76350000 0000062000
Nanomedizin Prof. Alexiou