Similarity assessment of charge variants for bevacizumab biosimilar formulations using imaged capillary isoelectric focusing

Imaged Capillary Isoelectric Focusing for Charge-Variant Analysis of Biopharmaceuticals

level: interMediAte Analyzing charge variants of therapeutic proteins is critical for characterizing and monitoring quality attributes of antibodies. Charge variants include deamidation, formation of N-terminal pyroglutamate, aggregation, isomerization, sialylated glycans, antibody fragmentation, and glycation at the lysine residues. In some cases, such changes affect binding, biological activi...

Quantification of hemoglobin variants by capillary isoelectric focusing.

Capillary isoelectric focusing (cIEF) was used to identify and quantify major and minor hemoglobin (Hb) variants. Whole blood (approximately 10 microL required) hemolysate was analyzed with a commercial instrument equipped with a 50 microns (i.d.) x 27 cm coated capillary filled with 20 g/L ampholytes (pH 6-8) in 4 g/L methylcellulose (MC). Cathode and anode solutions were 20 mol/L NaOH and 100...

Capillary Isoelectric Focusing

Beale SC (1998) Capillary electrophoresis. Analytical Chemistry 70: 279. (This journal prints every two years a review on capillary electrophoresis. The article is written by an expert in the Reld and covers more or less all developments in CE including CGE of the preceding years.) Grossmann PD and Colburn JC (eds) (1996) Capillary Electrophoresis: Theory and Practice. San Diego: Academic Press...

Optimizing Conditions for Capillary Isoelectric Focusing Separations Using

Charge Variants of an Avastin Biosimilar Isolation, Characterization, In Vitro Properties and Pharmacokinetics in Rat

The similarity between a proposed biosimilar product and the reference product can be affected by many factors. This study is designed to examine whether any subtle difference in the distribution of the charge variants of an Avastin biosimilar can affect its in vitro potency and in vivo PK. Here, the acidic, basic and main peak fractions of a biosimilar product were isolated using high-performa...