GMP Production


Head of Department:
Prof. Dr. med. Dr. h. c. Heinrich Iro

GMP Production

the Pharmacy of the University Hospital Erlangen, Palmsanlage 3

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 ( The available manufacturing facility complies with all relevant regulations, such as the EU GMP Guide, the GCP Regulation and the German Pharmaceutical Law.

Mini Pilot Reactor in the clean room

Synthesis reactor MiniPilot 2 special (Büchi AG)

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.

Contact at SEON

Contact at the Pharmacy

Ralph Heimke-Brinck
phone: +49 9131/85-39041


Dr. sc. hum. Tobias Borst
Pharmacist Pharmacist
Tel: 09131-85-33595/-39285


10 years SEON
Nanopartikel mit Ultraschall sichtbar machen
Manfred-Roth-Foundation supports SEON research project

Donations account

Forschungsstiftung Medizin at the Universitätsklinikum Erlangen

Sparkasse Erlangen
IBAN: DE 69 76350000 0000062000
Intended use:
Nanomedizin Prof. Alexiou

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