A scientific review describes how lyophilization and formulation optimization—supported by process analytics—help stabilize antibody-drug conjugates (ADCs) across formulation and manufacturing stages. The report focuses on structural stability risks during processing, aiming to reduce degradation pathways that can affect potency and safety. The discussion emphasizes the practical toolbox for sponsors: selecting stabilizers and process conditions, then validating stability with advanced analytics suitable for complex, heterogeneous ADCs. By framing lyophilization as a defensible strategy rather than an afterthought, the review targets a known translational bottleneck in ADC scale-up. For development teams, the report supports evidence-based process decisions that can influence final product consistency and lifecycle economics.
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