Mycenax Biotech Inc.


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Formulation Development

Mycenax has developed numerous formulations for complex biopharmaceutical products by using reliable formulation development strategies. We have an in-depth understanding of the challenges and characteristics of biopharmaceutical formulations and have established a superior formulation database to shorten the development time.

Our approach for formulation development consists of three steps:

  1. Pre-formulation study: physicochemical characterization under process related stress to gather the physical and chemical degradation pattern
  2. Formulation optimization study: statistical experimental design to identify optimal conditions and to evaluate the impact of additional stabilizers on product stability
  3. Stability study: pilot stability study in the selected container closure system to confirm compatibility and to generate data for real-time stability

Our Capabilities

  • Design and execution of formulation development strategies for complex biopharmaceutical formulations
  • Conduct of accelerated and stress studies to identify suitable formulations under process related stress and to understand the physical and chemical degradation pathway
  • Identification of excipients and optimal conditions to maintain protein properties and long-term product stability
  • Comprehensive analytical physicochemical characterization of formulations

Equipment and Technology

  • Purity determination by size exclusion chromatography (SEC), ion exchange chromatography, reversed phase chromatography (RP-HPLC), hydrophobic interaction chromatography (HIC), SDS-PAGE, capillary electrophoresis
  • Particulate matter analysis by FlowCam, DLS
  • Structure analysis by CD, DSC
  • Viscosity analysis
  • Binding assays