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> Anticuerpos Antiidiotípicos
Un idiotopo es el conjunto único de determinantes antigénicos (epítopos) de la porción variable de un anticuerpo. Un anticuerpo anti-idiotípico (Anti-ID) se une al idiotopo de otro anticuerpo, generalmente un fármaco de anticuerpos, lo que lo convierte en una herramienta muy poderosa para el desarrollo de fármacos de anticuerpos, especialmente para inmunogenicidad y análisis PK/PD.
Para respaldar la inmunogenicidad preclínica/clínica y el análisis farmacocinético, ACROBiosystems ha desarrollado una serie de anticuerpos antiidiotípicos de alta afinidad. Nuestra cartera cubre cinco objetivos principales, incluidos adalim*mab, Ritux*mab, Cetux*mab, Trastuz*mab y Bevaciz*mab. Para ayudar en el proceso de desarrollo de fármacos, proporcionamos protocolos de ensayo que se pueden aplicar a diferentes escenarios de aplicación.
| 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-Y29 | Anti-Cetuxi*ab Antibodies (AY29) (recommended for PK/PD) | Neutralizing Antibody | PK bridging ELISA; Neutralizing 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) | Neutralizing Antibody | PK bridging ELISA |
| Trastuzu*ab | TRB-Y1b | Anti-Trastuzu*ab Antibodies (AY1b) (recommended for PK/PD) | Neutralizing Antibody | PK bridging ELISA; Neutralizing assay; Indirect ELISA |
Las proteínas terapéuticas como los anticuerpos monoclonales son actualmente esenciales en el tratamiento del cáncer, enfermedades autoinmunes y otras enfermedades. Dado que la proteína tiene su característica intrínseca de inmunogenicidad debido a su estructura que contiene epítopos potenciales de células B y células T, las proteínas terapéuticas tienen el potencial de inducir anticuerpos antidrogas (AA), incluso si la proteína tiene la misma secuencia de aminoácidos que la endógena humana. proteínas La aparición de AA en pacientes puede conducir potencialmente a la pérdida de eficacia y/o eventos adversos. Por lo tanto, la evaluación del riesgo de inmunogenicidad y las estrategias de mitigación del riesgo son necesarias durante el desarrollo de productos proteicos terapéuticos.
El desarrollo interno de un anticuerpo monoclonal o multiclonal como control positivo para el ensayo AA requiere mucho tiempo. Para resolver este problema, ACROBiosystems desarrolló una serie de estándares de anticuerpos antidrogas para ensayos de AA.
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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