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Sie suchen in allen Bereichen nach dem Autor Katterle B.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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MerkenHow stable are new biologics?
Rubrik: Originale
(Treffer aus pharmind, Nr. 11, Seite 1557 (2018))
How stable are new biologics? / Insights into the stress profiles of an antibody-based biopharmaceutical drawing on the example of Adalimumab · Katterle B · Eurofins BioPharma Product Testing Munich GmbH, Munich
Stability of Biopharmaceuticals Stress Conditions Analytical Testing Chromatographic and Electrophoretic Methods This article describes the exposure of the commercially available therapeutic antibody Humira® (Adalimumab) to the various stress conditions in order to detect any possible change of the monoclonal antibody sequence and structure (monoclonal antibody – mAB). Quality control (QC) testing of protein biologics is one of the critical parts of biopharmaceutical manufacturing. The analytical results of various QC testing methods help to define and monitor the batch to batch variations [ 2 ]. Any profound structural changes in the protein will affect activity and safety. In this case, actions ...
