ProJect Pharmaceutics isa leading European CRO service providerspecialized in formulation and manufacturing process development for injectabledrug products: biologics (rec. proteins, antibodies, fusion proteins), peptides, ADCs,cytotoxics, small molecules, generics, viral therapeutics, ATMPs, VLPs, and othernanoparticular drug delivery systems.We apply innovative, quality-by-designbased, rational concepts of pharmaceutical development according to ICHQ8 andother guidelines. We support our globalcustomers in developing a consistentlyhigh-quality pharmaceutical product thatis transferable, scalable and manufacturable under GMP conditions.

Drug formulation services:

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

Freeze drying:

• Lyo cycle development
• Bulk lyophilization (solid, powder)
• Freezedrying 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 & acceleratedstability studies
• Sterile filtration study
• Fill&finish process mock-up
• Manufacturability assessment
• Aseptic pre-clinicalbatch manufacturing

Fill&finish:

Partnered with GermanCMO for liquid filling into vials and forlyophilization of DP for clinic and market