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For biological sample processing inside the manufacture of therapeutic proteins or cell and gene therapies, to circumvent downstream contaminationEndotoxin amounts of the drug substance have been subsequently lowered if the microbiological levels of the procedure water ended up lowered and the procedure water system was managed.Cite Although each e
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) where the active component comprises A significant percentage of the pill and in which Charge of excess weight can be presumed to become an satisfactory control of drug material uniformity. Body weight variation just isn't an satisfactory indication of material uniformity in which the drug compound comprises a relatively insignificant percentage
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