Molecular Weight Analysis of Glatiramer Acetate and Related Compounds by Size-Exclusion Chromatography with Multi-Angle Light Scattering Detection (SEC-MALS)

被引：0

作者：

Glajch, Joseph L. ^{[1
]}

Li, Ying ^{[1
]}

Fu, Wing-Yee ^{[1
]}

Coleman, Claire ^{[1
]}

Lyer, Mani ^{[1
]}

Kaminski, Harper ^{[1
]}

Todd, Jason ^{[2
]}

Rumfeldt, Timothy ^{[2
]}

机构：

[1] Momenta Pharmaceut Inc, Cambridge, MA 02142 USA

[2] Polymer Solut Inc, Christiansburg, VA USA

来源：

LC GC NORTH AMERICA | 2020年 / 38卷 / 02期

关键词：

D O I：

暂无

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The molecular weight characterization of heterogeneous polymer mixtures is complicated by the fact the molecular weight standards are often not available, or not appropriate, for a specific polymer. In cases such as heparins and glatiramer acetate, single molecular structures are not adequate for creating a molecular weight calibration curve. This work reports on the use of size-exclusion chromatography with multi-angle light scattering detection (SEC-MALS) for the accurate determination of molecular weight and distribution for the polypeptide mixture glatiramer acetate and higher molecular weight precursors. Method development is described, along with the analysis of multiple samples to demonstrate method validation and application to process samples.

引用

页码：89 / 97

页数：9

共 3 条

[1] Demonstration of equivalence of a generic glatiramer acetate (Glatopa™) [J].