We offer integrated and systematic formulation and process development services focusing on monoclonal antibodies, Antibody Drug Conjugate (ADC), fusion proteins, blood factors and bispecific antibodies. Quality by design approach will be used to quickly choose the appropriate formulation, and a series of researches will be performed to meet the preferential timeline for IND filing.
• Preformulation screening, consist of pH, excipient and surfactant screening
• Formulation development and optimization
• Design of Experiment (DOE) to identify optimal formulation and CQAs
• Forced degradation studies to identify degradation pathways
• Primary Container compatibility
• Clinical in-use stability study including dilution effect and injection kit compatibility
• Fill and finish support to Tox run production
• CMC dossier for IND filing