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> Anti-idiotypische Antikörper
Ein Idiotop ist die einzigartige Menge antigener Determinanten (Epitope) des variablen Teils eines Antikörpers. Ein anti-idiotypischer (Anti-ID) Antikörper bindet an das Idiotop eines anderen Antikörpers, normalerweise eines Antikörper-Medikaments, was ihn zu einem sehr leistungsfähigen Werkzeug für die Entwicklung von Antikörper-Medikamenten macht, insbesondere für die Immunogenitäts- und PK/PD-Analyse.
Zur Unterstützung der vorklinischen/klinischen Immunogenitäts- und PK-Analyse hat ACROBiosystems eine Reihe hochaffiner anti-idiotypischer Antikörper entwickelt. Unsere Pipeline umfasst fünf heiße Ziele, darunter adalim*mab, Ritux*mab, Cetux*mab, Trastuz*mab und Bevaciz*mab. Um den Arzneimittelentwicklungsprozess zu unterstützen, stellen wir Testprotokolle bereit, die auf verschiedene Anwendungsszenarien angewendet werden können.
| Molecule | Cat. No. | Antigen | Neutralizing Activity | Application |
|---|---|---|---|---|
| Adalimu*ab | ADB-Y19 | Anti-Adalimu*ab Antibodies (AY19) | Neutralizing Antibody | ADA assay; Neutralizing assay; 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 |
| 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 |
Therapeutische Proteine wie monoklonale Antikörper sind derzeit bei der Behandlung von Krebs, Autoimmunkrankheiten und anderen Krankheiten unerlässlich. Da Protein die intrinsische Eigenschaft der Immunogenität aufweist, was an seiner potenziell B-Zellen- und T-Zellen-Epitope enthaltenden Struktur liegt, haben therapeutische Proteine das Potenzial, Anti-Drug-Antikörper (ADA) zu induzieren, selbst wenn das Protein dieselbe Aminosäuresequenz hat wie der endogene human Proteine. Das Auftreten von ADA bei Patienten kann möglicherweise zu einem Wirksamkeitsverlust und/oder Nebenwirkungen führen. Daher sind während der Entwicklung therapeutischer Proteinprodukte eine Immunogenitäts-Risikobewertung und risikomindernde Strategien erforderlich.
Die interne Entwicklung eines mono-/multiklonalen Antikörpers als Positivkontrolle für den ADA-Assay ist extrem zeitaufwändig. Um dieses Problem zu lösen, hat ACROBiosystems eine Reihe von Anti-Drogen-Antikörper-Standards für ADA-Assays entwickelt.
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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