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Degradation of IAPs and NIK stabilisation has been extensively described by drugs called SMAC mimetics [66, 67], nonetheless degradation of IAPs and subsequent NIK accumulation was still observed when caspase-independent cell death was induced in the absence of intermembrane space proteins SMAC and OMI [38]

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At least two terminations: Related to stoppering issues and extrinsic particles Were not captured as deviations at the time of occurrence Media fills were re-executed and accepted: Without documented root cause analysis Without documented CAPA implementation Without evaluation of aseptic control failure modes SEE ALSO: Media Fill Tests: Aseptic Process Simulation (APS) in Sterile Manufacturing FDAs Core Concern The firm repeatedly relied on passing sterility, endotoxin, and environmental monitoring results to justify the conclusion that no product impact existed