논문 (학술지)
A single liquid chromatography-quadrupole time-of-flight mass spectrometric method for the quantification of total antibody, antibody-conjugated drug and free payload of antibody-drug conjugates
| 등록번호 | RPMS-2019-0190755864 | SCI 구분
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※구분 : SCI(SCIE포함), 비SCI |
SCI |
|---|---|---|---|
| 저자명 (주·공동저자) | Byeon Jin‐ Ho; Shin Seok‐Ho; Lee Byeong ill; Park Yuri; Choi Jangmi; Kim Nahye; Kang Yeonjae; Shin Young G. | ||
| 논문구분 | 국외전문학술지 | 학술지명 | BIOMEDICAL CHROMATOGRAPHY |
| ISSN | 0269-3879 | 학술지 출판일자 | 2018-03-30 |
| 학술지 볼륨번호 | 32 | 논문페이지 | e4229 ~ - |
| 학술지 임팩트팩터 | 0.0 | 기여율 | 100 % |
| DOI | 10.1002/bmc.4229 | ||
| 초록 | A single hybrid affinity-captured-LC-TOF-MS/MS method was developed and applied for the quantification of total antibody, antibody conjugated drug and free payload of antibody drug conjugate (ADC). Adcetris®, one of the valine-citrulline MMAE (vc-MMAE) conjugated ADC, was used as a model ADC compound. A quadratic regression (weighted 1/concentration) was used to fit calibration curves over the concentration range of 30.65-613.00 ng/mL with an equation y=ax2+bx+c for the acDrug of Adcetris®. The qualification run met the acceptance criteria of ± 25% accuracy and precision values for quality control samples. For the analysis of total antibody, a signature peptide (TTPPVLDSDGSFFLYSK, M.W. 1874) was used after affinity-capture using magnetic beads and on-bead trypsin digestion. A quadratic regression (weighted 1/concentration) was used to fit calibration curves over the concentration range of 5.00-100.00 μg/ml with an equation y=ax2+bx+c for total antibody. For free payload analysis of MMAE, a protein precipitation method followed by LC-TOF-MS/MS analysis was used. A quadratic regression (weighted 1/concentration) was used to fit calibration curves over the concentration range of 1.01-2200 ng/ml with an equation y=ax2+bx+c for free payload. Pharmacokinetic study samples and in vitro stability samples in rat were successfully analyzed by this a hybrid affinity-captured-LC-TOF-MS/MS method. This single platform method was a useful complementary method for the pharmacokinetics study of ADC with valine-citrulline linker at the early drug discovery stage. | ||
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