CN

Formulation Process Development

Extensive R&D experience in mAbs, bsAbs, fusion proteins, ADCs, and other liquid & lyophilized powder formulations.

Provides robust formulations and scalable processes to meet the formulation and process development requirements of various biopharmaceutical products.

  • Development and optimization of high-concentration formulations and lyophilized formulations
    Stability studies: stress test (High temperature, Light exposure, Repeated freeze-thaw cycles, Agitation/shaking), as well as accelerated and long-term stability studies
    Evaluation of the suitability and sealing integrity of packaging materials
    Compatibility stability studies based on ICH guidelines and pharmacopoeial standards of different countries
    Studies on sterilization processes
    Studies on freeze-thaw, mixing, and pump shear forces
    Process characterization by scale-down model

Main Equipment

31.jpg/
32.jpg/
33.jpg/
0.143376s