ProJect Pharmaceutics GmbH

ProJect Pharmaceutics is a leading European CRO service provider specialized in formulation and manufacturing process development for injectable drug products: biologics (rec. proteins, antibodies, fusion proteins), peptides, ADCs, cytotoxics, small molecules, generics, viral therapeutics, ATMPs, VLPs, and other nanoparticular drug delivery systems. We apply innovative, quality-by-design based, rational concepts of pharmaceutical development according to ICHQ8 and other guidelines. We support our global customers in developing a consistently high-quality pharmaceutical product that is transferable, scalable and manufacturable under GMP conditions.

Drug formulation services:

• Predictive formulation analytics – a QbD-based high-throughput approach for accelerated development
• Pre-formulation, early state and late phase formulation
• Liquid and lyophilized formulation (DoE-based)
• High concentration formulation (DoE)
• UF/DF process development
• Particle size distribution & aggregate analysis
• Sub-visible particles
• Viscosity & syringeability determination
• Liposomal encapsulation
• Analytical characterization

Freeze drying:

• Lyo cycle development
• Bulk lyophilization (solid, powder)
• Freeze drying out of organic solvents
• Time lapse video & IR thermal camera monitoring
• Robustness & design space evaluation
• Smooth technology transfer to GMP

Process development and manufacturing:

• Container closure compatibility testing
• Forced stress, in-use & accelerated stability studies
• Sterile filtration study
• Fill&finish process mock-up
• Manufacturability assessment
• Aseptic pre-clinical batch manufacturing

Fill&finish:

Partnered with German CMO for liquid filling into vials and for lyophilization of DP for clinic and market