Understanding the inherent instabilities of multispecific antibodies and their impact on developability
02 Sept 2026
Bi/Multispecifics
- How can you identify the major liabilities unique to your bi/multispecific antibody, and how can developability assessments help detect them early?
- How are analytical methods affected by the unique challenges presented by multispecific antibodies, and when should orthogonal techniques and further characterization be leveraged?
- How can biophysical techniques and mass spectrometry be used to troubleshoot manufacturing challenges inherent to bi/multispecific antibodies?
- With limited material available, what decisive screening cascade—including pH, excipients, viscosity, and freeze–thaw studies—should be used to select a clinical formulation within two to three months?
- What criteria should trigger a liquid versus lyophilized formulation decision during early-phase development, and how should the strategy be adapted if dosing requirements change after Phase I?
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