2024
DOI: 10.1515/pthp-2024-0001
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Focused physicochemical stability study of reconstituted trastuzumab biosimilar SB3 (Ontruzant®) stored in the original vials over 28 days

Laura Knoll,
Judith Thiesen,
Irene Krämer

Abstract: Objective Trastuzumab biosimilar SB3 (Ontruzant®), a HER2 binding monoclonal antibody, is available as powder for concentrate for solution for infusion. According to the summary of product characteristics, the reconstituted solution (21 mg/mL) is physicochemically stable for 7 days when stored refrigerated at 2–8 °C. The objective of this focused study was to determine the extended physicochemical stability of trastuzumab SB3 reconstituted with water for injection and stored in the original g… Show more

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