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Worth the rough stretch
From a regulatory perspective, biocatalytic processes introduce novel considerations for GMP documentation: enzyme sourcing (GMO status, origin traceability), enzyme lot-to-lot variability controls, and the potential for enzyme-related impurities in the API product
Novo Nordisk's Oral Semaglutide Enters Market with Emisphere's SNAC Technology Novo Nordisk's oral formulation of the blockbuster peptide GLP-1 agonist semaglutide, is now coming to market in an orally dosed formulation
Ozempic is the brand name for semaglutide, a once-weekly GLP-1 receptor agonist used to improve blood glucose control in people with type 2 diabetes
(4) The whole process is only deprotected in the last step, and frequent deprotection is not needed, so that racemization of amino acid and introduction of other impurities are not basically caused
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