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Consequently, regulatory focus will center on providing strain-specific evidence of genetic stability, absence of toxin production, and a complete safety dossier for the final product, constituting a substantial regulatory threshold prior to market approval

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A mildly acidic to near-neutral pH window is generally preferred, and compatibility trials with the specific preservative system, chelator, and surfactant package are recommended

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Konopleva M, McQueen T, Tsao T, Monaco G, Lapillonne H, R-Y W, Younes A, Belmont J, Sporn MB, Andreeff M

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