抗Payload抗體
抗體藥物偶聯(lián)物（ADCs）是一種新型的抗癌藥物，結(jié)合了單克隆抗體和小分子毒素，具有高度靶向性和高毒素性。由于ADC 給藥后會(huì)發(fā)生payload 的解結(jié)合，導(dǎo)致未結(jié)合的payload 的增加和ADC 成分（即DAR 分布）的變化。因此，對(duì)偶聯(lián)的抗體和偶聯(lián)在抗體上的payload 的體內(nèi)定量分析有助于評(píng)估ADC 藥效，并有助于評(píng)估payload 在靶點(diǎn)的暴露情況，且確定DAR 分布和平均DAR 值的變化對(duì)于提供ADC 的穩(wěn)定性等整體評(píng)估至關(guān)重要。
華美CUSABIO推出適用于臨床前及臨床階段抗體藥有效研究工具——抗Payload抗體。可用于ADC藥物的血漿/血清動(dòng)力學(xué)分析、藥物結(jié)合親和力的測(cè)定、DAR值分析以及ADC藥物的療效評(píng)估。
抗Payload抗體類(lèi)型
ADC 各成分與其對(duì)應(yīng)分析方法
ADC 的生物分析需要一種綜合的生物分析方法，包括配體結(jié)合測(cè)定和高效液相色譜串聯(lián)質(zhì)譜聯(lián)用技術(shù)（LC-MS/MS），分別用于大分子和小分子生物分析。抗payload 抗體在ADC 的免疫原性分析中至關(guān)重要，用于免疫原性分析的橋接檢測(cè)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有效荷載-Anti DXD
圖1. DXD-新一代ADC最具前景的有效荷載 [1]
應(yīng)用場(chǎng)景
藥代動(dòng)力學(xué)（PK）分析
偶聯(lián)DAR值定性分析
免疫原性分析
臨床前及臨床階段抗藥物抗體開(kāi)發(fā)
產(chǎn)品優(yōu)勢(shì)
高純度
純度經(jīng)SDS-PAGE驗(yàn)證大于90%
高特異性
能夠特異性識(shí)別小分子毒素
高靈敏度，高親和性
經(jīng)ADC藥物結(jié)合驗(yàn)證表現(xiàn)出顯著活性
易于檢測(cè)，節(jié)省成本
經(jīng)過(guò)HRP標(biāo)記的抗DXD抗體方便檢測(cè)，且無(wú)需再與二抗結(jié)合
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產(chǎn)品列表
| 產(chǎn)品名稱(chēng) | 產(chǎn)品貨號(hào) | 應(yīng)用類(lèi)型 | 純化方法 |
|---|---|---|---|
| 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 |
| DM1 Monoclonal Antibody | CSB-MA989454I0m | ELISA | >95%, Protein G purified |
| DM1&DM4 Monoclonal Antibody | CSB-MA989811I0m | ELISA | >95%, Protein G purified |
| DM1&DM4 Monoclonal Antibody | CSB-MA989811I1m | ELISA | >95%, Protein G purified |
| DM1&DM4 Monoclonal Antibody | CSB-MA989811I2m | ELISA | >95%, Protein G purified |
| DM1&DM4 Monoclonal Antibody | CSB-MA989811I3m | 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 |
驗(yàn)證數(shù)據(jù)
(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.
定制服務(wù)
華美生物已研發(fā)多種高純度、高靈敏度，高親和力的抗Payload抗體，可用于ADC藥物的臨床前及臨床階段DAR值和PK分析，可提供定制化的抗Payload抗體，以滿(mǎn)足客戶(hù)的個(gè)性化需求。
參考文獻(xiàn)：
[1] Kumar, Seema, ed. An Introduction to Bioanalysis of Biopharmaceuticals. Vol. 57. Springer Nature, 2022.
