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Safety concerns included uncharacterized immunogenicity risks, inadequate impurity and endotoxin testing in available raw material, the unresolved free-base versus acetate salt form distinction, and, for BPC-157 specifically, an angiogenesis mechanism that raises theoretical concerns for patients with undiagnosed tumors

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It was first isolated from human plasma, where it naturally occurs at concentrations of around 200 ng/mL at age 20, declining to approximately 80 ng/mL by age 60