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

  • Mitarbeiterzahl

    9
  • Kategorien
    • Auftragsforschung
  • Gegründet

    2010
  • Aktualisiert am

    26.07.2024