Aseptic Preclinical Batch Manufacturing / Non-GMP Pilot Study Supply

Non-GMP pilot batch manufacturing of pre-clinical batches for liquid and lyophilized drug delivery systems: ensured sterility through use of permeable lyophilization bags, and supported by valid documentation for pre-clinical study supply or Tox batch supply.

Manufacturing of pilot samples for i.e. stability studies as well as for pharmacokinetic, pharmacodynamic and GLP toxicology studies. Aseptic manufacturing of liquid or lyophilized test samples:

  • Batches of several hundred vials or syringes (single or nest&tub configuration)
  • Processing adjusted to large-scale manufacturing including filter types, filling pumps, holding times, contact materials, etc.
  • Identifying critical process parameters to define process specifications and/or design space according ICH Q8
  • Mock-up simulation of clinical / commercial manufacturing processes (compounding, filtration, filling, freeze drying)
  • Aseptic compounding using pre-sterilized components and final sterile filtration
  • Use of certified components, filled into the original primary packaging system
  • Aseptic freeze drying to manufacture representative samples
  • Individual vial labelling or bulk labelling upon request
  • Provision of GMP-like documentation
  • Management of technology transfer and scaling-up to clinical and commercial scale at dedicated manufacturing organizations
  • Project realization in short time (< 4 weeks)

Aseptic Freeze-Drying in Safety Containment Systems

  • Cytotoxic OEL4 and/or BSL-2 pilot labs with dedicated freeze dryers
  • Aseptic compounding using pre-sterilized components and final sterile filtration
  • Use of permeable lyophilization bags as a safety containment for highly infectious or toxic compositions (protection from the inside), and avoiding contamination (protection from the outside)