Formulation/Aseptic filling

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