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These considerations are managed by trial sponsors under Good Manufacturing Practice (GMP) conditions and are not applicable to unregulated powder products, for which no validated stability data exist
Animal studies have revealed that secondary bile acids may impair the integrity of the BBB
Yeasts such as Saccharomyces cerevisiae and Pichia pastoris provide simple, fast and scalable culture, but their hypermannosylated glycosylation patterns may affect pharmacokinetics and promote immunogenicity of the product [44]
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