Physicochemical stability study of MYL-1401O, a biosimilar of trastuzumab, following a transient temperature excursion
| Autor: | Guillaume Le Guyader, Victoire Vieillard, Muriel Paul |
|---|---|
| Přispěvatelé: | Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Henri Mondor, Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12) |
| Rok vydání: | 2020 |
| Předmět: |
Filgrastim
Light Stability study Drug Storage 02 engineering and technology Pharmacology Transient temperature 030226 pharmacology & pharmacy Polyethylene Glycols 03 medical and health sciences 0302 clinical medicine Drug Stability Nephelometry and Turbidimetry Trastuzumab Scattering Radiation Medicine Pharmacology (medical) Biosimilar Pharmaceuticals Chromatography High Pressure Liquid Drug Packaging business.industry Excursion Temperature Biosimilar [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences Chromatography Ion Exchange 021001 nanoscience & nanotechnology Spectrometry Fluorescence Oncology Chromatography Gel Spectrophotometry Ultraviolet Powders 0210 nano-technology business medicine.drug |
| Zdroj: | Journal of Oncology Pharmacy Practice Journal of Oncology Pharmacy Practice, 2021, 27 (4), pp.847-856. ⟨10.1177/1078155220940410⟩ |
| ISSN: | 1477-092X 1078-1552 |
| Popis: | Introduction The extended stability of the trastuzumab biosimilar Ogivri™ (MYL-1401O; trastuzumab-dkst) was studied under different storage conditions, including following reconstitution of the lyophilized powder (21 mg/mL) but undiluted and stored in vials at 4°C; after dilution at two concentrations (0.8 and 2.4 mg/mL) in polyolefin bags and stored at 4°C; and following a three-day thermal excursion to 25°C. Methods Several methods were utilized to assess the physical and chemical stability of the drug under different storage conditions. Results At all storage conditions tested, there was no change in the tertiary structure of MYL-1401O as assessed by second-derivative ultraviolet and fluorescence-derived spectral analysis, and no evidence of oligomer formation or fragmentation was observed as assessed by gel exclusion chromatography and dynamic light scattering, confirmed by assessment of quinary structures using size-exclusion chromatography. Ion-exchange chromatography showed no significant changes in the distribution of ionic variants, particularly deamidations. Thermal denaturation curves indicated no destabilization of the three-dimensional structure after 90 days at 4°C or after thermal excursion for 72 h at 25°C. Conclusion The trastuzumab biosimilar MYL-1401O maintained its physical and chemical stability for at least 90 days at 4°C or after thermal excursion to 25°C, supporting the safe use of MYL-1401O in several real-world settings, including advanced preparation for administration or when a break in the cold cycle occurs. |
| Databáze: | OpenAIRE |
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