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- FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standardsThe U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
- Integrating Multiple Stability Measurements Improves Early Biologics TestingJohn Stenson of Malvern Panalytical argues that combining several stability assays on a single platform can increase both throughput and data quality for early‑stage biologics development. He note…