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Service zur Anti-Idiotypischen Antikörperentwicklung

Anti-idiotypische Antikörper sind Antikörper, die die variable Region eines anderen Antikörpers erkennen und so eine spezifische Bindung herstellen. Anti-idiotypische Antikörper werden in der Arzneimittelentwicklung häufig eingesetzt. Sie können als wichtige Referenz für die Immunogenitätsanalyse verwendet werden und sind in der Lage, spezifisch Antikörperspiegel von Arzneimitteln im Körper nachzuweisen. Daher sind anti-idiotypische Antikörper ein wichtiges Reagenz für die Pharmakokinetikforschung.

Als globale Marke, die sich auf Proteintechnologie, Produkte und Dienstleistungen für die Entwicklung biologischer Arzneimittel konzentriert, ist ACROBiosystems bestrebt, qualitativ hochwertige Zielantigene und Schlüsselreagenzien sowie damit verbundene Dienstleistungen anzubieten, die für die Entwicklung zielgerichteter therapeutischer Arzneimittel erforderlich sind. ACRO bietet eine Reihe von anti-idiotypischen Antikörpern mit hoher Affinität, hoher Spezifität und hoher Empfindlichkeit. Um den unterschiedlichen Bedürfnissen der Kunden gerecht zu werden, bietet ACRO ebenso Dienstleistungen aus einer Hand an, von der Antigenpräparation über die Entwicklung von monoklonalen Anti-Idiotyp-Antikörpern und polyklonalen Anti-Idiotyp-Antikörpern bis hin zur Entwicklung von Pharmakokinetik- und Immunogenitätstests.

Vorteil


Hardware Strength

Through the international AAALAC certification, we can standardize the management and use of animals to ensure the quality of antibodies.


Efficient Project Management

Dedicated one-on-one service with our project team with fast response and follow-up.


High Quality Materials

Key reagents for PK/ADA analysis are provided for a variety of different types of therapeutic drugs including monoclonal antibodies, bispecific antibodies, ADCs, and CAR-T).


Multifunctional Service

Services starting from antigen preparation to monoclonal / polyclonal anti-idiotype antibody development and PK/immunogenicity testing kit development.


Compliant with Regulatory Guidelines

We ensure that our PK/ADA test kits are delivered with sensitivity that meets regulatory requirements.

Überblick über die Serviceleistungen

Monoclonal anti-idiotypic antibodies preparation service mouse

We provide custom development of anti-idiotypic antibodies that are either antigen-neutralizing, non-neutralizing or drug target compound types. Depending on your application, these monoclonal anti-idiotypic antibodies can be used in the detection of free, bound, or total drug concentration in pharmacokinetic studies.

ada_2
Antigen blocking type(Neutralizing)
Paratope specific
Block antigen-antibody binding
Detection of free antibody drugs
Detection of neutralizing antibodies
ada_3
Antigen non-blocking type (Non-neutralizing)
Paratope non-specific
Not block antigen-antibody binding
Detection of total antibody drugs (free, semi-bound, bound)
ada_4
Drug target compound type
Specific binding drug target complex
Not block antigen- antibody binding
Specific detection of bound antibody drugs
Polyclonal anti-idiotypic antibody preparation service mouse

For immunogenicity studies, we provide high-affinity and specific polyclonal anti-idiotypic antibody development services. These highly sensitive and diverse polyclonal anti-idiotypic antibodies can be used as a positive reference in immunogenicity studies, simulating the production of ADA inside the human body.

Development of blood drug concentration/immunogenicity detection kit

In order to further support and facilitate your preclinical and clinical research of antibody drugs, we also offer our ELISA kit development services for immunogenicity (anti-drug antibody, ADA) or pharmacokinetic (PK) assays. Immunogenicity assays are used to quantify the level of immune response against the targeted therapeutic, while pharmacokinetic assays are used to elucidate the drug concentration and drug clearance within the body. Both assays are critical regulatory requirements for drug development, IND applications, clinical trials and post-marketing monitoring.

ACROBiosystems provides custom development services for both drug concentration and ADA detection kits for customers' diversified needs and applications while also providing key reagents for PK and immunogenicity analysis of biological drugs.

CAR-T
Name Period Delivery Price

Anti-idiotypic rabbit polyclonal antibody preparation

8-10 weeks

  • 1. Rabbit antiserum;

  • 2. Immunoaffinity chromatography purified polyclonal antibody (specific amount according to customer's demand), liquid/lyophilised product available,  buffer customised ;

  • 3. 1-3mg of synthetic antigen;

  • 4. Quality inspection report (COA);

  • 5. Complete experiment report.

One-on-one service of the project team
According to your needs
Issue a customized plan for you


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Anti-idiotypic mouse monoclonal antibody preparation

4-5 months

  • 1. positive cell lines;

  • 2. Ascites;

  • 3. purified antibodies (specific amount customised according to customer requirements);

  • 4. Quality inspection report (COA);

  • 5. Complete experiment report.

Development of a quantitative detection kit for blood drug concentration

5-7 weeks

  • 1. Methodology verification report;

  • 2. Instructions, COA;

  • 3. ELISA kit

ACRO Anti-idiotypic Antibody Products
Molecule Cat. No. Product Description 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) 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

Development Process

Fallstudie

PK assay——Specific detection of antibody drug levels in vivo
Case study: bispecific antibody drug under PK assay with a sensitivity of 0.24ng/ml.
Immunization with full-length bispecific antibodies yielded blocking clones against Arm1 and Arm2.
Screened blocking clones against Arm 1

Clone1 Clone2 Clone3 Clone4 Clone5 Clone6 Clone7 Clone8 Clone9 Clone10 A0
OD 0.142 0.063 0.107 0.143 0.208 0.264 0.23 0.148 0.149 0.22 1.601
blocking rate 91.13% 96.06% 93.32% 91.07% 87.01% 83.51% 85.63% 90.76% 90.69% 86.26% /

Clone11 Clone12 Clone13 Clone14 Clone15 Clone16 Clone17 Clone18 Clone19 Clone20 A0
OD 0.295 0.228 0.119 0.098 0.078 0.229 0.516 0.709 0.923 0.965 1.601
blocking rate 81.57% 85.76% 92.57% 93.88% 95.13% 85.7% 67.77% 55.72% 42.35% 39.73% /
Screened blocking clones against Arm 2

Clone1 Clone2 Clone3 Clone4 Clone5 Clone6 Clone7 Clone8 Clone9 Clone10 A0
OD 0.109 0.232 0.178 0.158 0.146 0.276 0.245 0.106 0.165 0.198 1.546
blocking rate 92.95% 84.99% 88.49% 89.78% 90.56% 82.15% 84.15% 93.14% 89.33% 87.19% /

Clone11 Clone12 Clone13 Clone14 Clone15 Clone16 Clone17


A0
OD 0.48 0.495 0.387 0.658 0.064 0.651 1.062


1.546
blocking rate 68.95% 67.98% 74.97% 57.44% 95.86% 57.89% 31.31%


/
The paired antibodies were selected from the blocking clones of Anti-Arm1 and Anti-Arm2 for sandwich method development as well as bispecific antibody drug PK detection, the standard curve is as follows:
PK assay——Specific detection of antibody drug levels in vivo

Immobilized anti-arm1 antibody can bind Bispecific antibody drugs, and then add Biotin- anti-arm2 antibody. Detection was performed using HRP-conjugated streptavidin with sensitivity of 0.24 ng/mL (Intact Assay).

Case study：ADC drug under PK assay with a sensitivity of 0.69ng/ml.
Naked F(ab)2 was used for immunization and the anti-idiotype antibody obtained after screening, and the ADC drug PK was detected together with Mouse Anti-MMAE Antibody, Mouse IgG1 (MALS verified) (Cat. No. MME-M5252). The standard curve is as follows:
PK assay——Specific detection of antibody drug levels in vivo

Immobilized Anti- drug Antibody, Mouse IgG1 can bind ADC antibody drugs, and then add Biotin- Mouse Anti-MMAE Antibody, Mouse IgG1 (MALS verified). Detection was performed using HRP-conjugated streptavidin with sensitivity of 0.69 ng/mL (Intact Assay).

Comparison of different methods for detecting antibody drug levels in vivo
Testing method Coated Sample Testing
Antigen capture ELISA CD20 Antibodies to be tested Goat anti-human IgG
Anti-idiotypic capture ELISA Anti-Ritux*mab Antibodies Antibodies to be tested Goat anti-human IgG
Bridging ELISA by anti-idiotypic antibodies Anti-Ritux*mab Antibodies Antibodies to be tested Biotinylated Anti-Ritux*mab Antibodies
Figure1. Detection of Ritux*mab by antigen-capture ELISA (0.1% serum).
Figure2. Detection of Ritux*mab by anti-idiotypic capture ELISA (0.1% serum).
Figure3. Detection of Ritux*mab by anti-idiotypic bridging ELISA (10% serum).
Testing method Linear range
（µg/mL） 		Sensitivity
（µg/mL） 		Advantage Disadvantage
Antigen-capture ELISA — — Simple method and good versatility High background, no activity
Anti-idiotypic capture ELISA 0.156-10 0.156 Solve the difficulty in obtaining CD20, simple method High background, only suitable for Rituxa biosimilar
Bridging ELISA by anti-idiotypic antibodies 0.012-0.78 0.012 Solve the difficulty in obtaining CD20, good sensitivity and low background Only applicable to Rituxan biosimilar
ADA assay—Immunogenicity analysis
The case of rabbit polyclonal antibody
Case study: Antibody cross-reaction verification

New Zealand white rabbits were immunized with full-length monoclonal antibodies. The antiserum was affinity purified for polyclonal antibodies specific to the drug. Cross reactivity to subtype control was less than 2%.

Case study：Antidrug antibody potency test for peptides

New Zealand white rabbits were immunized with polypeptide-KLH conjugates. Antiserum was purified by affinity chromatography until antibody titer was more than 1:712,000.

The case of mouse monoclonal antibody

Anti-Adalimumab Antibodies bridging ELISA for Anti-Drug Antibody (ADA) assay development. Immobilized adalimumab at 1 µg/ml, add increasing concentrations of Anti-Adalimumab Antibodies (Cat. No. ADB-Y19, 10% human serum) and then add biotinylated adalimumab at 5 µg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 0.6 ng/mL.

Anti-Rituximab Antibodies bridging ELISA for Anti-Drug Antibody (ADA) assay development. Immobilized rituximab at 1 µg/ml, added increasing concentrations of Anti-Adalimumab Antibodies (Cat. No. RIB-Y36, 10% human serum) and then added biotinylated rituximab at 2 µg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 9.7 ng/mL.

Anfrage und Bestellung

Anfrage und Bestellung

  • Ein Wissenschaftler von ACROBiosystems wird innerhalb von 24 Stunden nach der Einreichung antworten.

  • Rufen Sie uns an: +1 800-810-0816 oder E-Mail an services@acrobiosystems.com für eine Beratung.

Sprechen Sie mit einem Wissenschaftler
  • Hintergrund
  • Vorteil
  • Überblick über die Serviceleistungen
  • Development Process
  • Fallstudie
  • Anfrage und Bestellung