ProJect Pharmaceutics GmbH

ProJect Pharmaceutics is one of the leading European CRO service providers specialized in formulation and manufacturing process development for parenteral drug products, including biologics (rec. proteins, antibodies, fusion proteins), peptides, ADCs, cytotoxics, small molecules, generics, viral therapeutics, cell & gene therapy products, GMOs, ATMPs, VLPs, and other nanoparticular drug delivery systems. We pursue innovative, quality-by-design based, rational concepts of pharmaceutical development following ICHQ8 and other guidelines. We support our worldwide clients to develop a consistently high-quality pharmaceutical product, transferable, scalable and manufacturable under GMP conditions.

Drug formulation services:

• Accelerated development (DoE)
• Preformulation, early state and late phase formulation
• Liquid and lyophilized forms › High concentration formulation
• Low viscosity formulation (DoE)
• UF/DF process development
• Particle size distribution & aggregate analysis
• Sub-visible particles
• Viscosity & syringeability determination
• Liposomal encapsulation
• Analytical characterization

Process and manufacturing:

• Container closure compatibility testing
• Thermal characterization
• Forced stress studies, real-time, accelerated and in-use stability studies
• Fill&finish process mock-up
• Manufacturability assessment
• Aseptic pre-clinical batch manufacturing

Freeze drying:

• Lyo cycle development
• Bulk lyophilization
• Freeze drying out of organic solvents
• Robustness testing & definition of design space
• Smooth technology transfer

Fill&finish: Partnered with German CMO for liquid filling into vials and for lyophilization of DP for clinic and market