Effect of mobile phase composition on the analysis of aggregates of antibody drug conjugates (ADCs) using size exclusion chromatography

2018 ◽  
Vol 10 (9) ◽  
pp. 938-941 ◽  
Author(s):  
Rabin Neupane ◽  
Malin Källsten ◽  
Fredrik Lehmann ◽  
Jonas Bergquist

In this study, the effect of mobile phase composition for size exclusion chromatography (SEC) on antibody drug conjugate (ADC) aggregate analysis was investigated.

Author(s):  
Tomohiro Fujii ◽  
Calliste Reiling ◽  
Colette Quinn ◽  
Michal Kliman ◽  
Brian A. Mendelsohn ◽  
...  

Aim: Direct analytical comparison of two major drug-linkers in the antibody-drug conjugate (ADC) field was conducted. Methods: Four different analytical methods [AlogP calculation, reverse phase (RP) high-performance liquid chromatography (HPLC; RP-HPLC), size exclusion chromatography HPLC (SEC-HPLC), and differential scanning calorimetry (DSC)] were tested for this comparison. Results: Maytansinoid-based ADCs showed less hydrophobicity than auristatin-based ADCs. Regardless of the drug-linker and drug-to-antibody ratios (DARs), the stability detected by DSC was decreased by conjugation. Conclusions: The cost and time-efficient analytical comparison described in this manuscript may be useful information for an initial characterization of ADCs prior to detailed biological studies.


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