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항이디오타입 항체
항-이디오타입 항체는 다른 항체의 가변 영역을 인식하고 특이적 결합을 생성하는 항체입니다. 항-이디오타입 항체는 의약품 개발에 널리 사용되며 면역원성 분석에 중요한 참고로 사용될 수 있으며 생체 내 항체 약물 수준을 특이적으로 검출할 수 있으며 약물동태학 연구에 중요한 시약입니다.
위의 연구를 지원하기 위해 ACROBiosystems는 면역원성 분석 및 약물동태학 연구를 위한 일련의 고친화성, 고특이성 항이디오타입 항체를 개발했습니다. 각각의 항이디오타입 항체에 대해, 우리는 약물 개발 과정을 최대한 가속화하기 위해 다양한 응용 시나리오에 따라 해당 실험 프로토콜을 개발할 것입니다.현재 제품은 adalim*mab, Ritux*mab, Cetux*mab, Trastuz*mab, and Bevaciz*mab, bevacizumab 등과 같은 많은 인기있는 항체 약물을 커버했습니다.
Molecule | Cat. No. | Antigen | Neutralizing Activity | Application |
---|---|---|---|---|
Adalimu*ab | ADB-Y19 | Anti-Adalimu*ab Antibodies (AY19) | Neutralizing Antibody | ADA assay; Neutralizing assay; Indirect ELISA |
Adalimu*ab | ADB-Y23b | Anti-Adalimu*ab Antibodies (AY23b) (recommended for PK/PD) | Non-Neutralizing Antibody | PK bridging ELISA; Indirect ELISA |
Bevacizu*ab | BEB-Y10 | Anti-Bevacizu*ab Antibodies (AY10) (MALS verified, recommended for PK/PD) | Neutralizing Antibody | PK bridging ELISA; Neutralizing assay; Indirect ELISA |
Bevacizu*ab | BEB-Y12 | Anti-Bevacizu*ab Antibodies (AY12) (recommended for neutralizing assay) | Neutralizing Antibody | ADA assay; Neutralizing assay; Indirect ELISA |
Bevacizu*ab | BEB-Y9 | Anti-Bevacizu*ab Antibodies (AY9) (recommended for ADA assay) | Neutralizing Antibody | ADA assay; Neutralizing assay; Indirect ELISA |
Bevacizu*ab | BEB-BY13 | Biotinylated Anti-Bevacizu*ab Antibodies (AY13) (recommended for PK/PD) | Neutralizing Antibody | PK bridging ELISA;Neutralizing assay; Indirect ELISA |
Cetuxi*ab | CEB-Y27 | Anti-Cetuxi*ab Antibodies (AY27) (recommended for ADA assay) | Neutralizing Antibody | ADA assay; Neutralizing assay; Indirect ELISA |
Cetuxi*ab | CEB-Y31 | Anti-Cetuxi*ab Antibodies (AY31) (Non-Neutralizing) | Non-Neutralizing Antibody | ADA assay; Indirect ELISA |
Cetuxi*ab | CEB-Y28 | Anti-Cetuxi*ab Antibodies (AY28) | Neutralizing Antibody | ADA assay; Neutralizing assay; Indirect ELISA |
Cetuxi*ab | CEB-BY31 | Biotinylated Anti-Cetuxi*ab Antibodies (AY31) (recommended for PK/PD) | Non-Neutralizing Antibody | PK bridging ELISA; Indirect ELISA |
Rituxi*ab | RIB-Y36 | Anti-Rituxi*ab Antibodies (AY36) (recommended for ADA assay) | Neutralizing Antibody | ADA assay;Neutralizing assay; Indirect ELISA |
Rituxi*ab | RIB-Y37 | Anti-Rituxi*ab Antibodies (AY37) (recommended for PK/PD) | Neutralizing Antibody | PK bridging ELISA;Neutralizing assay;Indirect ELISA |
Rituxi*ab | RIB-FY35c | FITC-Labeled Anti-Rituxi*ab Antibodies, Mouse IgG1 | Neutralizing Antibody | ADA assay;Neutralizing assay; Indirect ELISA |
Rituxi*ab | RIB-Y35c | Anti-Rituxi*ab Antibodies (MALS verified) | Non-Neutralizing Antibody | ADA assay; Indirect ELISA |
Trastuzu*ab | TRB-Y5b | Anti-Trastuzu*ab Antibodies (AY5b) (recommended for PK/PD) | Non-Neutralizing Antibody | Neutralizing Antibody |
Trastuzu*ab | TRB-Y1b | Anti-Trastuzu*ab Antibodies (AY1b) (recommended for PK/PD) | Neutralizing Antibody | PK bridging ELISA; Neutralizing assay; Indirect ELISA |
거의 모든 생물학적 제제는 특정 항약물 항체(ADA)를 생성하며, ADA의 생성은 약물의 효능을 감소시키거나 심각한 부작용을 유발할 수 있습니다. 전임상 연구에 따르면 ADA는 약물 노출, 약물 독성, 약물동태학 및 약력학에 영향을 미칠 수 있습니다. 생물학적 분자의 면역원성을 평가하고 실험 결과를 임상 사건과 연결하기 위해서는 전임상 및 임상 연구 모두에서 ADA 반응을 효과적으로 평가할 수 있는 신뢰할 수 있는 실험 방법을 개발할 필요가 있습니다.
ADA 검출 방법은 표준화된 ADA표준품이 없어서 일반적으로 비정량적 실험입니다. 양성 대조군은 일반적으로 사내에서 개발된 단클론 또는 다클론 항체를 사용하니까 시간이 많이 걸립니다. 이 문제를 해결하기 위해 ACROBiosystems는 해당 항체 및 바이오시밀러의 ADA 검출 표준으로 일련의 ADA를 개발했습니다.
Anti-Ritux*mab Antibodies bridging ELISA for Anti-Drug Antibody (ADA) assay development. Immobilized Ritux*mab at 1 µg/ml, added increasing concentrations of Anti-Ritux*mab Antibodies (Cat. No. RIB-Y36, 10% human serum) and then added biotinylated Ritux*mab at 2 µg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 9.7 ng/mL.
Anti-Ritux*mab Antibodies bridging MSD for Anti-Drug Antibody (ADA) assay development. Added the mix solution (biotinylated Ritux*mab at 5 µg/mL, SULFO-Ritux*mab at 5Nµg/mL and increasing concentrations of Anti-Ritux*mab Antibodies (Cat. No. RIB-Y36, 100% human serum). Detection was performed using MSD Assay with a sensitivity of 0.97 ng/mL.
Anti-Adalim*mab Antibodies bridging ELISA for Anti-Drug Antibody (ADA) assay development. Immobilized adalim*mab at 1 µg/ml, add increasing concentrations of Anti-Adalim*mab Antibodies (Cat. No. ADB-Y19, 10% human serum) and then add biotinylated adalim*mab at 5 µg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 0.6 ng/mL.
Comparison between anti-idiotypic capture ELISA and anti-idiotypic bridging ELISA for Ritux*mab detection in patient samples. Left: anti-idiotypic capture ELISA; Right: anti-idiotypic bridging ELISA.
Detection of Ritux*mab by bridging ELISA in serum. Immobilized Anti-Ritux*mab Antibodies (Cat. No. RIB-Y37) at 2 μg/ml, added increasing concentrations of Ritux*mab (10% human serum) and then added biotinylated Anti-Ritux*mab Antibodies (Cat. No. RIB-BY35) at 1 μg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 1 ng/ml.
Anti-Adalim*mab Antibodies (mouse IgG1, Cat. No. ADB-Y19) captured on CM5 chip via anti-mouse antibodies surface, can bind human adalim*mab with an affinity constant of 1.36 pM.
Demonstration of the specificity of Anti-Cetux*mab Antibodies (Cat. No. CEB-Y28) to the Cetux*mab.
Reconstituted Anti-Trastuz*mab Antibodies were diluted to 0.4 mg/ml, aliquoted and placed at 37°C. Aliquots were removed from 37°C at every time point and placed at 4°C along with the control. No significant loss of activity was observed.
Anti-Trastuz*mab Antibodies were subjected to the indicated number of freeze-thaw cycles (FT). No significant loss of activity was observed.
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