| Autor: |
Vats, Bhavesh, Goyal, Parag, Mathew, Zacharia, Ghosh, Ranendu, Babu, Moram Narendra, Jadav, Rahul Singh, Nair, Arya M., Subbarao, Malini, Bera, Arnab, Prakash Sadasivappa, Kirthi, Kabadi, Pradeep, Sarkar, Anindya, Honnappa, Chethan Gejjalagere, Patnaik, Uma Sankar, Singh, Ankita, Parambath, Anusha Valiya, Ullanat, Rajesh |
| Zdroj: |
Expert Opinion on Biological Therapy; February 2022, Vol. 22 Issue: 2 p299-311, 13p |
| Abstrakt: |
ABSTRACTBackgroundMYL-1401O; trastuzumab-dkst (Ogivri™; Mylan Inc.) is a biosimilar to the trastuzumab reference product (Herceptin®; Genentech, USA). Assessment of physicochemical stability and biological activity for the non-reconstituted, reconstituted, and infused solution over an extended, clinically relevant duration is critical for ensuring optimal patient outcomes and health resource utilization.MethodsThe physicochemical and biological stability of MYL-1401O was assessed in non-reconstituted vials stored at 25 °C ± 2 °C/60% ± 5% relative humidity (RH) for 6 months, reconstituted 21 mg/mL solution in vials stored at 2 °C to 8 °C for 10 days, and diluted in 0.9% saline-containing infusion bags at 0.3 mg/mL and 4.0 mg/mL stored for 77 days at 2 °C to 8 °C, plus an additional 2 days at 25 °C ± 2 °C/60% ± 5% RH.ResultsAt all storage conditions tested, MYL-1401O was physicochemically and biologically stable for extended duration and under various temperature and humidity conditions.ConclusionsMYL-1401O retained its physicochemical and biological stability under different storage conditions, which supports advanced preparation of MYL-1401O, better efficiency, less wastage, and cost-savings for better patient management. |
| Databáze: |
Supplemental Index |
| Externí odkaz: |
|
