Shim-pack Bio HIC Butyl, 4um, 4.6x100

Shim-pack Bio HIC Column is a hydrophobic interaction chromatography (HIC) column packed with butyl bonded hydrophilic nonporous polymer particles (4 μm). HIC is suitable for the separation of anlaytes with slightly different hydrophobicity, such as antibody-drug conjugate (ADC) with different drug-antibody ratios (DAR). Shim-pack Bio HIC can be used for the analysis of DAR of ADC with relatively low pressure and high resolution.

Need for DAR Analysis in ADCs

ADCs consist of lysine and cysteine residues of a monoclonal antibody (mAb) and small-molecule drugs (Fig.1). However, since mAbs contain multiple amino acid residues involved in their binding, the mAbs are known to form heterogeneous ADCs with different binding numbers and binding sites.

These heterogeneities can affect a drug's efficacy and safety, making analysis of the drug-antibody ratio (DAR) essential to determine the quality characteristics of ADCs. In addition, maintaining the distribution of DAR within a certain range enables quality assurance in ADC manufacturing.

Excellent Reproducibility to Help Calculate DAR

Reproducibility of area values obtained from repeat injections (n= 6) of cysteine-conjugated ADC samples and an example of an automated DAR calculation report are shown below. (DAR can be calculated automatically using LabSolutions DB/CS custom reporting.) The Shim-pack BIO HIC, developed for biopharmaceutical analysis, makes it possible to detect slight differences in hydrophobicity of small-molecule drugs and perform rapid DAR analysis with high resolution.

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