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.

Small batch 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 and production examples:

Aseptic Freeze-Drying in Safety Containment Systems