Antibody-drug conjugates (ADCs) present formulation challenges that extend beyond those of conventional monoclonal antibodies. Conjugation influences molecular stability throughout development, requiring formulation strategies tailored to the characteristics of each molecule.
This whitepaper explores how Samsung Biologics approaches ADC formulation development by integrating analytical characterization, formulation development, and process considerations to support more robust manufacturing outcomes.
Key highlights include:
How conjugation influences critical stability attributes and drives molecule-specific formulation strategies
Considerations for buffer selection, excipient screening, process-stress studies, lyophilization development, and photostability assessment
Strategies for identifying formulation vulnerabilities early and connecting analytical insights to process controls
Discover how an integrated approach to ADC formulation development can support more robust development and manufacturing.
Antibody-drug conjugates (ADCs) present formulation challenges that extend beyond those of conventional monoclonal antibodies. Conjugation influences molecular stability throughout development, requiring formulation strategies tailored to the characteristics of each molecule.
This whitepaper explores how Samsung Biologics approaches ADC formulation development by integrating analytical characterization, formulation development, and process considerations to support more robust manufacturing outcomes.
Key highlights include:
- How conjugation influences critical stability attributes and drives molecule-specific formulation strategies
- Considerations for buffer selection, excipient screening, process-stress studies, lyophilization development, and photostability assessment
- Strategies for identifying formulation vulnerabilities early and connecting analytical insights to process controls
Discover how an integrated approach to ADC formulation development can support more robust development and manufacturing.
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