Analyses of Antibody Drugs Using Ultra High Performance Liquid Chromatography

User Benefits

- Highly reproducible data can be acquired by suppressing the interaction between antibody drugs and stationary phase. - Highly stable data can be acquired even when using a mobile phase containing high concentrations of corrosive salts.

Introduction

Biopharmaceuticals are being developed using biotechnology techniques such as genome editing and cell fusion. Recently, some of them have been spread worldwide due to be expected to be effective in treating various diseases including refractory diseases. Antibody drugs, such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), are known to offer high therapeutic efficacy and reduced side effects due to their specificity and affinity for target molecules. However, because these biopharmaceuticals are manufactured using animal cells, the challenge is to ensure their structural homogeneity that is not encountered in small molecule pharmaceuticals manufactured by chemical synthesis. Accordingly, biopharmaceuticals require appropriate quality controls at every production step. For example, ICH-Q6B, which proposes specifications and test procedures for biological products, stipulates that product-related impurities should be separated and/or determined the percentage levels in the manufacturing process. In most cases, these analyses are performed using liquid chromatography. This article introduces analyses of mAbs and ADCs for quality control using an inert UHPLC system “Nexera XS inert” that is extremely resistant to mobile phases containing high salt concentrations. The type of impurities and their amount are different depending on the type of antibody. Therefore, it is noteworthy that analytical conditions should be optimized for each sample. Thus, the optimization techniques will also be described in this article. In this article, we determined to use an appropriate column for each analysis.

March 1, 2022 GMT