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MerkenProtein-Reactive Extractables
Rubrik: Originale
(Treffer aus pharmind, Nr. 01, Seite 104 (2018))
Haep R | Stratmann A | Watt S | Martens L
Protein-Reactive Extractables / A Screening Assay Which Adds Additional Value to the Traditional E/L Workflow · Haep R, Stratmann A, Watt S, Martens L · A&M STABTEST GmbH, Bergheim und
Extractable Leachable Product Quality Research Institute (PQRI) protein-reactive rubber oligomer polysulfanes Most protein-based biopharmaceutical drug products with market authorization to date are administered parenterally and have to be formulated accordingly – either as a liquid for injection or as a lyophilisate which has to be reconstituted with a suitable diluent prior to administration. If the stability of the drug product permits, the formulation favored by the industry is a liquid for injection which is easier to develop, more cost effective to manufacture and easier as well as safer to use for healthcare professionals. For these products, glass vials with rubber ...
