Executive context
Most gene therapies and vector-enabled products will follow full BLA pathways; EUA is situational (e.g., emergency public-health vaccines). The Viral Vectors report tracks rising approval velocity—with >30 FDA/EMA approvals expected 2025–2030—making early alignment on CMC, comparability, and post-marketing commitments essential. itsallaboutpatents.com
Decision guardrails
• Evidence planning: IND → pivotal → BLA with validated assays and stability packages matched to vector type.
• Comparability: lock change-control; define analytics pre- and post-scale-up to avoid re-doing studies.
• Timelines & ROI: coordinate regulatory milestones with capacity booking to stay inside launch windows.
• When EUA?: narrowly scoped, benefit-risk clear, and manufacturing controls demonstrably mature.
Link back & next steps
Use the Viral Vectors report for scenario planning (base vs. accelerated vs. constrained) and to pressure-test regulatory timelines against supply readiness. Price $2,100 single-user; sample <24h.
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Next: See the Biopharma & Life Sciences guide or the full 2025–2033 report for forecasts and detailed methodology.