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Werkzeuge für die ADC-PK-Analyse - Anti-Payload-Antikörper

Product Features

High Purity (>95%): SDS-PAGE & SEC-MALS validation
High affinity: Verified by ADCs binding assay
High sensitivity: Specifically recognizes small molecule toxins
Comprehensive data:Provides thorough PK validation data references.
Complete technical support: Assists in establishing PK methodologies.
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Research Applications

ELISA PK/PD studies on ADCs in preclinical and clinical

Background

Antibody-drug conjugates (ADCs) consist of monoclonal antibodies (mAbs), cytotoxic payloads, and linkers. This complexity engenders heightened drug heterogeneity, thereby rendering the pharmacokinetic (PK) studies of ADCs notably intricate.

PK studies entail the meticulous examination and characterization of drug absorption, distribution, metabolism, and excretion (ADME) processes. Analytes for ADCs typically encompass total antibodies (both conjugated and unconjugated with cytotoxic payloads, DAR≥0); conjugated antibodies (antibody conjugated to payload, DAR≥1), the antibody-conjugated drug, free drugs, and their analogs.

The quantification of total antibodies and conjugated antibodies commonly employs ELISA (Enzyme-linked Immunosorbent Assay), while the analysis of antibody-conjugated drugs, free drugs, and their metabolites frequently involves LC-MS (Liquid Chromatograph Mass Spectrometer).

To support your ADCs PK studies in preclinical or clinical stages, we now offer multiple anti-payload antibodies with high affinity. These antibodies specifically bind to DXD, MMAE, DM-1, SN38, Eribuli*, and other molecules, ideal for ELISA assays in your ADC PK studies!

Type	Analyte Detail	Typical Method
Total Antibody	Conjugated, partially unconjugated, and fully unconjugated (DAR ≥ 0)	Ligand Binding Assay
Conjugated Antibody	Antibody with minimum DAR ≥ 1	Ligand Binding Assay
Antibody-conjugated Drug	Total small-molecule drug conjugated to Antibody	Affinity LC-MS / Ligand Binding Assay
Unconjugated Drug	Small molecule drug not conjugated to antibody	LC-MS
Total Drug	Total unconjugated and conjugated Drug	LC-MS

ADC molecule type and typical analytical methods for evaluation. ¹

Different LBA formats to analyze ADCs in serum ²

Produktliste

Ergänzende Daten

Case study: PK method development and sample Detection

Immobilized with anti-DXD antibody for quantitative detection of T-Dxd concentration in serum.

Immobilized Mouse Anti-DXD&Exatecan Antibody, Mouse IgG1, mAb (Cat. No. DXD-M684) at 1 μg/mL, add Trastuzum*b deruxtecan in the 50% Human serum and then add Biotinylated Human Her2, His,Avitag, premium grade (Cat. No. HE2-H82E2) at 0.5 μg/mL. Detection was performed using HRP-conjugated Streptavidin (Acro, Cat. No. STN-NH913) (Routinely tested).

Protocol

Immobilized with HER2, and adds Biotinylated anti-DXD antibody as the secondary antibody for quantitative measurement of T-Dxd concentration in serum.

Immobilized Human Her2, His Tag (Cat. No. HE2-H5225) at 1 μg/mL, add Trastuzum*b Deruxtecan in the 100% Human Serum and then add Biotinylated Anti-DXD Antibody, Mouse IgG1, Avitag (Cat. No. DXD-BVM807) at 0.05 μg/mL. Detection was performed using HRP-conjugated Streptavidin (Acro, Cat. No. STN-NH913) (QC tested).

Protocol

Immobilized with anti-MMAE antibody for quantitative detection of RC48 concentration in serum.

Immobilized Mouse Anti-MMAE&MMAF Antibody, Mouse IgG1 (Cat. No. MME-M5252) at 5 μg/mL, add Disitamab Vedotin (RC48) in the 50% Mouse serum and then add Biotinylated Human Her2, His,Avitag, premium grade (Cat. No. HE2-H82E2) at 0.5 μg/mL. Detection was performed using HRP-conjugated Streptavidin (Acro, Cat. No. STN-NH913) (Routinely tested).

Protocol

Immobilized with anti-DM1 antibody for quantitative detection of Trastuzum*b-DM1 concentration in serum.

Immobilized Monoclonal Anti-DM-1&DM-4 Antibody, Mouse IgG1 (Cat. No. DM1-Y73) at 5 μg/mL, add Trastuzum*b-DM1 in the 50% Human serum and then add Biotinylated Human Her2, His,Avitag, premium grade (Cat. No. HE2-H82E2) at 0.5 μg/mL. Detection was performed using HRP-conjugated Streptavidin (Acro, Cat. No. STN-NH913) (Routinely tested).

Protocol

Purity over 90% verified by SEC-MALS

The purity of Monoclonal Anti-DXD&Exatecan Antibody, Mouse IgG1 (Cat. No. DXD-M684) is more than 90% and the molecular weight of this protein is around 135-160 kDa verified by SEC-MALS.

The purity of Monoclonal Anti-MMAE&MMAF Antibody, Mouse IgG1 (Cat. No. MME-M5252) is more than 90% and the molecular weight of this protein is around 134-163 kDa verified by SEC-MALS.

High affinity with ADCs verified by ELISA

Immobilized ADC-DXD at 1 μg/mL (100 μL/well) can bind Mouse Anti-DXD&Exatecan Antibody, Mouse IgG1, mAb (Cat. No. DXD-M684) with a linear range of 0.1-4 ng/mL (Routinely tested).

Protocol

Immobilized Disitamab Vedotin (RC48) at 0.2 μg/mL (100 μL/well) can bind Monoclonal Anti-MMAE&MMAF Antibody, Mouse IgG1 (Cat. No. MME-M5252) with a linear range of 0.1-2 ng/mL (QC tested).

Protocol

Immobilized ADC-DM4 at 2 μg/mL (100 μL/well) can bind Monoclonal Anti-DM-1&DM-4 Antibody, Mouse IgG1 (Cat. No. DM1-Y73) with a linear range of 0.20-6.25ng/mL (Routinely tested).

Protocol

Immobilized ADC-DXD at 1 μg/mL (100 μL/well) can bind HRP conjugated Mouse Anti-DXD&Exatecan Antibody, Mouse IgG1 (Cat. No. DXD-PLM684) with a linear range of 0.5-31 ng/mL (Routinely tested).

Protocol

Anti-Idiotypic Antibody and Development Service

Anti-idiotypic antibodies are antibodies that target the variable region of another antibody to produce specific binding. These antibodies are widely used in drug development: they can be used as an important reference standard for immunogenicity analysis or can be developed to specifically detect antibody drug levels for pharmacokinetic studies.

We have developed a series of anti-idiotype antibodies with high affinity, high specificity and high sensitivity for immunogenicity analysis and pharmacokinetics studies.

Anti-Idiotypic Antibody

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

Anti-Idiotypic Antibody Development Service

To meet the more unique needs of our customers, we also provide a one-stop service, starting from antigen preparation to monoclonal / polyclonal anti-idiotype antibody and pharmacokinetic / immunogenicity test kit development.

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

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.

Click to Learn More Information about Anti-Idiotypic Antibody Development Service

Resources

Webinar playback and appointment

Addressing Challenges in Antibody-Drug Conjugate Development

Here is the brief recap of the webinar:ADCs have the potential to enable 'precision medicine' with a wide market reach.Challenges in ADCs include managing Target Affinity, enhancing payload conjugation, and assessing Payload Delivery in vivo Pharmacokinetics. We can provide high-quality solutions to address these challenges.

Watch Now

Building the Perfect Antibody-based Therapeutic from Selection to Engineering and Manufacturing

In this webinar, discover how advanced techniques such as Al-driven candidate selection optimization of antibody sequences, and precise conjugation methods come together to address some of the current challenges in antibody-based therapeutics.