先导抗体分子优化与检测

服务内容（以单抗为例）

服务名称 服务目录 交付 周期
基础成药性分析 质量属性 检测项目 加压条件

报告:

  • Tagg
  • 浓度
  • 纯度
 6-8周
无 40℃ 低pH 3.5
Tagg DLS ✔ - -
浓度 UV280 ✔ ✔ ✔
纯度 SEC-HPLC ✔ ✔ ✔
纯度 CE-SDS-NR ✔ ✔ ✔
升级成药性分析 质量属性 检测项目 加压条件

报告:

  • Tagg
  • Tm
  • 浓度
  • 纯度
  • 电荷变异体
 6-8周
无 40℃ 低pH 3.5 反复冻融
Tagg DLS ✔ - - -
Tm DSC ✔ - - -
浓度 UV280 ✔ ✔ ✔ ✔
纯度 SEC-HPLC ✔ ✔ ✔ ✔
纯度 CE-SDS-NR ✔ ✔ ✔ ✔
电荷变异体 icIEF ✔ ✔ ✔ ✔

部分仪器展示

  • HPLC/UHPLC

  • 毛细管电泳仪

  • 成像毛细管等电聚焦

案例分享

成药性分析为CMC候选分子的选择提供依据。在该案例中，分子C最终被选为CMC候选分子

Stability Analytical methods Changes from Tday0 and Tend
Candidate A Candidate B Candidate C
Free-thaw Appearance Remain the same Remain the same Remain the same
Stressful (40oC & 2 weeks) Appearance Remain the same Remain the same Remain the same
CE-SDS-NR Decrease ca.10% Remain the same Remain the same
SEC-HPLC Remain the same Remain the same Remain the same
PTM by MS ~ 10% deamidation (not CDR) ~ 10% deamidation (not CDR) ~ 5% Oxidation (not CDR)
cIEF Acidic and basic increased Main peak changed Acidic and basic increased
Bioactivity Remain the same Remain the same Remain the same
Acidic condtion (pH3.5 & 25°C & 4h) Appearance Remain the same slight suspension slight suspension
SEC-HPLC Decreased ca. 70% Decrease ca.40% Decrease ca.5%
PTM by MS ~ 10% deamidation (not CDR) ~ 20% Oxidation ( CDR) Remain the same
cIEF Remain the same Main peak changed Remain the same
Bioactivity Remain the same Decreased Remain the same