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