Table 1

Examples of modifiable biological critical quality attributes (CQA) of a monoclonal antibody

Biological CQAExample
Binding
  • Affinity

  • Avidity

  • Cross-reactivity

Effector function
  • Complement interaction

  • Neonatal Fc receptor interaction

  • Fcγ receptor interaction

  • Mannan binding lectin interaction

  • Mannose receptor interaction

Other biological properties
  • Pharmacokinetic properties

  • Immunogenicity