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. (1st February 2022)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Expert opinion on biological therapy. Volume 22:Number 2(2022)
• Page Start: 299
• Page End: 311
• Publication Date: 2022-02-01
• Subjects: Biosimilar -- MYL-1401O -- physicochemical -- biological activity -- stability -- trastuzumab; Gene therapy -- Periodicals; Protein drugs -- Periodicals; Peptide drugs -- Periodicals; Immunotherapy -- Periodicals; Drug delivery systems -- Periodicals; 615.5
• DOI: 10.1080/14712598.2021.1917546
• Languages: English
• ISSNs: 1471-2598

Abstract

ABSTRACT: Background: MYL-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. Methods: The 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. Results: At all storage conditions tested, MYL-1401O was physicochemically and biologically stable for extended duration and under various temperature and humidity conditions. Conclusions: MYL-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.