Estimation of protein aggregates in Darbepoetin alfa formulations by developing a single validated analytical method.

 0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Gurminder Bindra, Nupur Garg, Sakshi Gehlot, Krutika Goswami, Charu Mehra Kamal, Sanjay Mendiratta

Ngôn ngữ: eng

Ký hiệu phân loại: 001.4226 Research; statistical methods

Thông tin xuất bản: Netherlands : Journal of chromatography. B, Analytical technologies in the biomedical and life sciences , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 96230

Darbepoetin alfa is a new generation recombinant human erythropoiesis stimulating agent having extended half-life as compared to recombinant human erythropoietin. It is given as a life-saving drug for anemic disorders caused by chronic kidney diseases, cancer, etc. With the presence of commercial formulations of darbepoetin biosimilars in the market and non-availability of any established method in literature or testing guidelines in any compendia for their purity and quality, this research aims to develop a sensitive and robust method to determine the aggregate impurities by using size exclusion chromatographic technique. The method was optimized for sharp and high-resolution monomer peak of darbepoetin and other interferences which was further validated according to ICH Q2(R2) guidelines. The developed method was further tested on the commercial samples to verify the same. Additionally, stress testing of samples was done to simulate the after-production exposure and stability assessment. The results demonstrated that the method for analysing aggregates in darbepoetin is complying the criteria of being sensitive, specific, accurate, robust and reliable.
Tạo bộ sưu tập với mã QR

THƯ VIỆN - TRƯỜNG ĐẠI HỌC CÔNG NGHỆ TP.HCM

ĐT: (028) 36225755 | Email: tt.thuvien@hutech.edu.vn

Copyright @2024 THƯ VIỆN HUTECH