Formulation/Aseptic filling

Core capabilities:

• Fill & finish for small volume liquid drug products using disposable assemblies

  • to minimize dead volume and

  • to avoid cleaning validation

• Manufacturers Authorization for IMP manufacturing since 1999

• Manufacturers Authorization and GMP certificate valid for bulk manufacture, primary and secondary packaging, analytical testing and QP batch certification also covering biological products.

Our skills:

• Formulation and manufacturing process development following QbD guidelines

• Transfer of manufacturing processes to commercial manufacturers

• Development of primary packaging, container closure systems and packaging development for customized study designs 

• Manufacturing of IMP for clinical studies phase I to IV, incl. analytical testing and QP certification

  • bulk manufacturing

  • primary packaging

  • secondary packaging and labelling 

• Temperature controlled storage of IMPs (controlled room temperature, 2-8 °C, -20°C)

• Worldwide distribution & logistics of IMP

• Combination and comparator medication sourcing (incl. analytical testing)

Main Equipment:

• Vial washing machine (Cantel Germany GmbH)

• Vial filling line (OPTIMA packaging group GmbH)

• Freeze dryer (HOF Sonderanlagenbau GmbH)

• Hot air sterilizer - pass through model (Weiss Technik GmbH)

• Autoclave - pass through model (Getinge AB)

• Visual inspection, light box according to pharmacopeia