ProJect Pharmaceutics GmbH

Aseptic Preclinical Batch Manufacturing

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 batch production 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
• Process 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)