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)