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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)定量分析有助于評估ADC 藥效，并有助于評估payload 在靶點的暴露情況，且確定DAR 分布和平均DAR 值的變化對于提供ADC 的穩(wěn)定性等整體評估至關(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/血清動力學(xué)分析、藥物結(jié)合親和力的測定、DAR值分析以及ADC藥物的療效評估。

抗Payload抗體類型

ADC 各成分與其對應(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

DXD-新一代ADC最具前景的有效荷載

圖1. DXD-新一代ADC最具前景的有效荷載 [1]

應(yīng)用場景

藥代動力學(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發(fā)

產(chǎn)品優(yōu)勢

高純度

純度經(jīng)SDS-PAGE驗證大于90%

高特異性

能夠特異性識別小分子毒素

高靈敏度，高親和性

經(jīng)ADC藥物結(jié)合驗證表現(xiàn)出顯著活性

易于檢測，節(jié)省成本

經(jīng)過HRP標記的抗DXD抗體方便檢測，且無需再與二抗結(jié)合

專業(yè)技術(shù)團隊

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產(chǎn)品列表

產(chǎn)品名稱 產(chǎn)品貨號 應(yīng)用類型 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
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

驗證數(shù)據(jù)

High purity verified by SEC-HPLC and SDS-PAGE
(Code: CSB-MA996977I2m)
SDS-PAGE驗證

The Mouse Anti-DXD Antibody (Code: CSB-MA996977I2m) has a purity of more than 90% as determined by SEC-HPLC and SDS-PAGE.

High purity verified by SEC-HPLC and SDS-PAGE
(Code: CSB-MA943989I1m)
SDS-PAGE驗證

The Mouse Anti-DXD Antibody (Code: CSB-MA943989I1m) has a purity of more than 98% as determined by SEC-HPLC and SDS-PAGE.

The Binding Activity of Disitamab vedotin (Synonyms: RC48) with Anti-MMAE antibody
(Code: CSB-MA903890I1m)
活性驗證

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.

The Binding Activity of T-DXd(DS-8201) with Anti-DXD antibody
(Code: CSB-MA996977I2m)
活性驗證

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，以滿足客戶的個性化需求。

參考文獻：

[1] Kumar, Seema, ed. An Introduction to Bioanalysis of Biopharmaceuticals. Vol. 57. Springer Nature, 2022.