GMP-certified pharmacy

Profil has a full GMP manufacturing license for investigational medicinal products (IMP), including sterile dosage forms.

Facts and Figures

Manufacturing capabilities
  • Grade A laminar air flow (LAF) in grade B cleanroom
  • 2 separate grade C cleanrooms
  • Qualified person
  • Continuous monitoring of clinical building rooms for differential pressure, temperature and humidity (incl. 24 h alarm function)
  • Regular particle and microbiological monitoring
  • Regular process validation (media-fill)
Storage capabilities
  • Large facilities for storage at room temperature, 2–8°C and –20°C with continuous temperature monitoring system (incl. 24 h alarm function)
  • GMP facilities under regular supervision of health authorities (Bezirksregierung Düsseldorf)
Pharmaceutical services
  • Aseptic preparation of parenteral dosage forms
  • Manufacture of iv solutions containing stable isotopes (e.g., D2-glucose)
  • Manufacture of liquid oral dosage forms (solutions, suspensions)
  • Filling, packaging and labeling of oral dosage forms from bulk
  • Supply of comparator drugs
  • Controlled distribution of IMPs to study-centers (central pharmacy)
  • Import of medicinal products from non-EU countries to be used as IMPs (incl. comparators) in clinical trials
  • Development of IMP formulations in cooperation with partners

Online Seminar

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Dr. Christoph Kapitza

Our expert

Dr. Christoph Kapitza

CEO - Operations


Clean Room