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Regulatory environment (external): Active uncertainty - FDA's April 2026 proposal to restrict 503B compounding remains open for public comment through June 29, 2026

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Material can appear clean by conventional chromatography while still containing sequence variants, deamidation, oxidation, acylation variants or other subtle modifications that could affect potency, stability and potentially immunogenicity

Were covering what they are, their functions in the body, and which ones take the reins for the best immune-supporter