From Label to Launch: Formulation & CMC Lessons from FDA Approved Bispecific & Multispecific Antibodies
- Leveraging insights from FDA-approved Bispecific and Mult Specific Antibodies as a reference to define realistic pH ranges, protein concentrations, excipients and formulation design space from the outset
- Proactively understanding the aggregation risks and atypical stability profiles of complex formats to better anticipate and mitigate key developability challenges
- Applying a stability-first formulation strategy to support faster development by reducing the need for late-stage reformulation and streamlining overall CMC readiness