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Relevant EMA guidance includes EMEA/CHMP/BMWP/42832/2005 Rev 1, which supports lifecycle-based immunogenicity risk assessment

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The pellet containing the mitochondrial fraction was resuspended in incubation buffer (120 mM KCl, 10 mM Tris, 5 mM KH 2 PO 4 , adjusted to pH 7.4 with HCl)