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10.1093/eurjpc/zwad050 [DOI] [PubMed] [Google Scholar] 29.Bogers RP, Bemelmans WJE, Hoogenveen RT, Boshuizen HC, Woodward M, Knekt P, et al

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Key Analytical Concerns Solubility-related variability Non-covalent molecular association Aggregate formation Stability-indicating method validation Aggregation analysis is particularly important because molecular aggregation can affect: Product potency Pharmacokinetics Immunogenicity risk Long-term formulation stability Combining size exclusion chromatography (SEC) with MS-based analytical techniques significantly improves aggregate characterization and stability assessment accuracy

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Five half-lives is 30 days, roughly 4.5 weeks