Skip to main content
. Author manuscript; available in PMC: 2015 Jul 8.
Published in final edited form as: Anal Methods. 2014 May 13;6(15):5427–5449. doi: 10.1039/C4AY00447G

Table 7.

CE-based analysis of biosimilars

Analyte Mode Capillary Coating BGE Detection Notes Ref.
EPO glycoforms CZE 60 cm, 50 µm id UltraTrol™ LN 1 M acetic acid TOF-MS Multivariate statistical
approach for glycoform
analysis		 [125]
(1) Rituximab. trastuzumab,
and ranibizumab
(2) Infliximab and
bevacizumab
 CZE
 40.2 (30.2) cm,
50 µm id
 Polyacrylamide
 (1) 200 mM EACA-acetic acid,
30 mM lithium acetate,
0.05% HPMC, pH 4.8
(2) 150 mM EACE-acetic acid,
20 mM lithium acetate,
0.05% HPMC, pH 5.5		 UV 214 nm
 CZE methods tested against
orthogonal techniques for
mAb characterization
 [126]
Rituximab CGE NR NR NR UV 214 nm Size heterogeneity of mAbs [127]
Anti-α1-antitrypsin
mAb		 iCIEF iCE280 Analyzer;
50 mm, 100 µm id		 Fluorocarbon
(Protein Simple)		 Pharmalyte pH 5–8 UV 280 nm Interlaboratory study for
robustness		 [128]

Capillary: Actual length (effective length), inner diameter

ε-aminocaproic acid (EACA), Hydroxypropylmethyl cellulose (HPMC), Not reported (NP)