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Sie suchen in allen Bereichen nach dem Autor Gaderer S.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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MerkenSurface Plasmon Resonance for Determination of Potency
Rubrik: Wissenschaft
(Treffer aus pharmind, Nr. 07, Seite 909 (2022))
Surface Plasmon Resonance for Determination of Potency / Gaderer • Surface Plasmon Resonance · Gaderer S · VelaLabs GmbH, Wien (Austria)
Determination of biological activity is a key criterion when examining the quality of biological products. The ICH Guideline Q6B [ 1 ] defines the requirements for specifications for characterization, release, and stability testing of biological products to ensure safety and efficacy. Besides biological activity, other critical quality attributes (CQAs) have to be evaluated. These include physicochemical and immunochemical properties, quantity, purity, impurities, and contaminants. The quantitative measurement of biological activity is referred to as potency. An essential requirement for potency assays is the depiction of the mechanism of action (MOA) of the biological product by the test system. Applicability of specific ...
