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
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The combination of oxygen, water, and warmth speeds these transformations
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The incumbent supply line has been monopolized by a single company for over 100 years) and while many companies have tried, theyre not getting product from that supply line 2) commercial traction: the company had intended to expand production from current levels by a factor of 10
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