Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration

Vats, Bhavesh; Goyal, Parag; Zacharia, Mathew; Ghosh, Rabindra; Babu, Moram Narendra; Jadav, Rahul Singh; Nair, Arya M; Subbarao, Malini; Bera, Arnab; Sadasivappa, Kirthi Prakash; Kabadi, Pradeep; Sarkar, Anindya; Honnappa, Chethan Gejjalagere; Patnaik, Uma Sankar; Singh, Ankita; Parambath, Anusha Valiya; Ullanat, Rajesh

doi:10.1080/14712598.2021.1917546

Expert Opinion on Biological Therapy

2021

DOI: 10.1080/14712598.2021.1917546

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Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration

Bhavesh Vats

Parag Goyal

Mathew Zacharia

et al.

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Physicochemical stability of durvalumab (Imfinzi^®) concentrate for solution in original vials after first opening

Almasi,

Thiesen,

Krämer

2023

Pharmaceutical Technology in Hospital Pharmacy

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Objectives Durvalumab (Imfinzi®), a PD-L1 monoclonal antibody (mAb) medication is available as concentrate (50 mg/mL) for solution for infusion. The summary of product characteristics provides information about the physicochemical stability of ready-to-administer durvalumab preparations (vehicle solution 0.9 % NaCl, G5%), but not about the concentrate after first opening. The objective of this study was to determine the physicochemical stability of durvalumab concentrate for solution after first opening over a period of 28 days. Methods Imfinzi® vials were punctured and stored refrigerated (2–8 °C) or at room temperature (20–25 °C) light protected. At predefined time points (day 0, 7, 14, 21, 28) the physicochemical stability of the concentrated solution was determined by ion-exchange/size-exclusion high-performance liquid chromatography (IE-/SE-HPLC) with photodiode array detection and pH measurement. Vials were inspected with regard to changes of color, clarity, and visible particles at any time point. Results Regardless of the storage temperature, durvalumab 50 mg/mL solutions remained physiochemically stable for 28 days in punctured vials. The concentrations of durvalumab monomer remained unchanged and no secondary peaks (fragments, aggregates) were observed in any of the SE-HPLC chromatograms. The IE-HPLC test results showed no substantial changes of the peak areas of the main peak and of the acidic and basic charge variants during the whole storage period. Appearance and pH of the test solutions remained unchanged until the end of the study. Conclusions Regardless of storage conditions none of the analytical methods indicated physicochemical instability of the intact durvalumab monomer over the 28 days of the study. To avoid microbiological instability storage under refrigeration is recommended.

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Physicochemical stability of durvalumab (Imfinzi^®) concentrate for solution in original vials after first opening

Almasi,

Thiesen,

Krämer

2023

Pharmaceutical Technology in Hospital Pharmacy

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Focused physicochemical stability study of reconstituted trastuzumab biosimilar SB3 (Ontruzant^®) stored in the original vials over 28 days

Knoll,

Thiesen,

Krämer

2024

Pharmaceutical Technology in Hospital Pharmacy

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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 glass vials under refrigeration or at room temperature over a period of 28 days. Methods Ontruzant® vials were reconstituted with sterile water for injection and stored light protected at 2–8 °C in the refrigerator or at room temperature (15–25 °C, Ph. Eur.) over a maximum period of 28 days. At predefined time points (day 0, 7, 14, (21), 28) samples were withdrawn and analyzed by size-exclusion high-performance liquid chromatography with photodiode array detection, ultraviolet spectroscopy, and pH measurement. Test solutions were inspected for colour changes, clarity, and visible particles at each sampling time point. Results According to the size-exclusion chromatography assay, trastuzumab SB3 monomer concentrations exceeded 95 % of the initially measured concentrations over the entire study period. pH values and trastuzumab concentrations measured by UV remained unchanged. No colour changes or visible particles were detected. Results were independent from storage temperature. Conclusions According to the stability indicating methods used, physicochemical stability of reconstituted trastuzumab SB3 Ontruzant® solution in original glass vials is given over a period of 28 days either stored refrigerated or at room temperature. Results have to be substantiated by IE-HPLC or icIEF. To avoid microbiological instability storage under refrigeration is recommended.

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Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration

Cited by 2 publications

References 11 publications

Physicochemical stability of durvalumab (Imfinzi^®) concentrate for solution in original vials after first opening

Physicochemical stability of durvalumab (Imfinzi^®) concentrate for solution in original vials after first opening

Focused physicochemical stability study of reconstituted trastuzumab biosimilar SB3 (Ontruzant^®) stored in the original vials over 28 days

Contact Info

Product

Resources

About

Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration

Cited by 2 publications

References 11 publications

Physicochemical stability of durvalumab (Imfinzi®) concentrate for solution in original vials after first opening

Physicochemical stability of durvalumab (Imfinzi®) concentrate for solution in original vials after first opening

Focused physicochemical stability study of reconstituted trastuzumab biosimilar SB3 (Ontruzant®) stored in the original vials over 28 days

Contact Info

Product

Resources

About

Physicochemical stability of durvalumab (Imfinzi^®) concentrate for solution in original vials after first opening

Physicochemical stability of durvalumab (Imfinzi^®) concentrate for solution in original vials after first opening

Focused physicochemical stability study of reconstituted trastuzumab biosimilar SB3 (Ontruzant^®) stored in the original vials over 28 days