抗Payload抗体
抗体药物偶联物（ADCs）是一种新型的抗癌药物，结合了单克隆抗体和小分子毒素，具有高度靶向性和高毒素性。由于ADC 给药后会发生payload 的解结合，导致未结合的payload 的增加和ADC 成分（即DAR 分布）的变化。因此，对偶联的抗体和偶联在抗体上的payload 的体内定量分析有助于评估ADC 药效，并有助于评估payload 在靶点的暴露情况，且确定DAR 分布和平均DAR 值的变化对于提供ADC 的稳定性等整体评估至关重要。
华美CUSABIO推出适用于临床前及临床阶段抗体药有效研究工具——抗Payload抗体。可用于ADC药物的血浆/血清动力学分析、药物结合亲和力的测定、DAR值分析以及ADC药物的疗效评估。
抗Payload抗体类型
- Anti DXD mAb
- Anti SN38
- DM1
- Anti MMAE
- Anti Eribulin
- DM4
ADC 各成分与其对应分析方法
ADC 的生物分析需要一种综合的生物分析方法，包括配体结合测定和高效液相色谱串联质谱联用技术（LC-MS/MS），分别用于大分子和小分子生物分析。抗payload 抗体在ADC 的免疫原性分析中至关重要，用于免疫原性分析的桥接检测方法（Bridging LBA）。
| Analyte Type | Description | Typical analytical platforms |
|---|---|---|
| Total antibody | Total antibody (conjugated or unconjugated) | LBA, hybrid LC-MS/MS |
| Total ADC | Total conjugated antibody (DAR > 1)OR | LBA |
| Total payload conjugated to antibody (DAR > 1) | LBA hybrid LC-MS/MS | |
| Unconjugated payload | Payload not conjugated to antibody | LC-MS/MS |
(Faria et al., 2022. Doi:10.1007/978-3-030-97193-9_3)
ADC有效荷载-Anti DXD
图1. DXD-新一代ADC最具前景的有效荷载 [1]
应用场景
药代动力学（PK）分析
偶联DAR值定性分析
免疫原性分析
临床前及临床阶段抗药物抗体开发
产品优势
高纯度
纯度经SDS-PAGE验证大于90%
高特异性
能够特异性识别小分子毒素
高灵敏度，高亲和性
经ADC药物结合验证表现出显著活性
易于检测，节省成本
经过HRP标记的抗DXD抗体方便检测，且无需再与二抗结合
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产品列表
| 产品名称 | 产品货号 | 应用类型 | 纯化方法 |
|---|---|---|---|
| DXD Recombinant Monoclonal Antibody | CSB-RA996977I1m | ELISA | Affinity-chromatography |
| DXD Recombinant Monoclonal Antibody | CSB-RA996977I1h | ELISA | Affinity-chromatography |
| DXD Monoclonal Antibody | CSB-MA996977I1m | ELISA | >95%, Protein G purified |
| DXD Monoclonal Antibody | CSB-MA996977I2m | ELISA | >95%, Protein G purified |
| DXD Monoclonal Antibody, HRP conjugated | CSB-MA996977I1m-B | ELISA | >95%, Protein G purified |
| DXD Monoclonal Antibody, HRP conjugated | CSB-MA996977I2m-B | ELISA | >95%, Protein G purified |
| Eribulin Recombinant Monoclonal Antibody | CSB-RA943989I1m | ELISA | Affinity-chromatography |
| Eribulin Monoclonal Antibody | CSB-MA943989I1m | ELISA | >95%, Protein G purified |
| MMAE&MMAF Recombinant Monoclonal Antibody | CSB-RA903890I1m | ELISA | Affinity-chromatography |
| MMAE&MMAF Monoclonal Antibody | CSB-MA903890I1m | ELISA | >95%, Protein G purified |
| SN38 Recombinant Monoclonal Antibody | CSB-RA187707I1m | ELISA | Affinity-chromatography |
| SN38 Monoclonal Antibody | CSB-MA187707I1m | ELISA | >95%, Protein G purified |
验证数据
(Code: CSB-MA996977I2m)
The Mouse Anti-DXD Antibody (Code: CSB-MA996977I2m) has a purity of more than 90% as determined by SEC-HPLC and SDS-PAGE.
(Code: CSB-MA943989I1m)
The Mouse Anti-DXD Antibody (Code: CSB-MA943989I1m) has a purity of more than 98% as determined by SEC-HPLC and SDS-PAGE.
(Code: CSB-MA903890I1m)
Activity: Measured by its binding ability in a functional ELISA. Immobilized Disitamab vedotin (Synonyms: RC48) at 2 μg/mL can bind Anti-MMAE antibody, the EC50 is 11.65 to 15.97 ng/mL.
(Code: CSB-MA996977I2m)
Activity: Measured by its binding ability in a functional ELISA. Immobilized T-DXd(DS-8201) at 2 μg/mL can bind Anti-DXD antibody, the activity was 4-5 times that of other companies.
定制服务
华美生物已研发多种高纯度、高灵敏度，高亲和力的抗Payload抗体，可用于ADC药物的临床前及临床阶段DAR值和PK分析，可提供定制化的抗Payload抗体，以满足客户的个性化需求。
参考文献：
[1] Kumar, Seema, ed. An Introduction to Bioanalysis of Biopharmaceuticals. Vol. 57. Springer Nature, 2022.
