An Introduction Bispecific Antibody Therapeutics Bispecific antibodies, as the name…
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Sep
Bispecific Antibody Drug Assays
Bispecific antibodies, as the name suggests, are antibodies with two binding sites – directed against two different antigens, or in some cases, two different epitopes on the same antigen. While mAbs have become mainstays in various therapies, they have several limitations – not including failed treatment responses and the development of drug resistance. Tumors are multi-factorial, with multiple signaling pathways implicated in pathogenesis, that often doesn’t allow for single-drug treatments to be as powerful a therapeutic option.
Following years of R&D, the approval of catumaxomab (anti-EpCAM and anti-CD3) and blinatumomab (anti-CD19 and anti-CD3) was a major milestone in the development of bsAbs., with four more being approved globally to date. Structural diversity has been fast-growing in the bispecific antibody field, creating a plethora of novel bispecific antibody scaffolds, which provide great functional variety. Over 230 are in pre-clinical studies or clinical investigations.
For those working with existing targets for development of new indications, combinations and biosimilars / biologic generics, Krishgen offers a range of 40+ ELISA to quantify drug levels accurately and quickly in serum and plasma samples. These bispecific antibody drug ELISA can be used for pharmacokinetic analysis and therapeutic drug monitoring.
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Unique
Sensitive and Highly Specific
Validated and Robust
Unique
- Currently the only ELISA in the world available for detection of bispecific antibody drugs
- Wide range of specific assays available for various bispecific antibodies
Sensitive and Highly Specific
- These ELISA employ anti-idiotypic monoclonal antibodies in a dual capture sandwich assay format, ensuring exceptional specificity and sensitivity in drug detection, even at low concentrations.
- Calibrated against innovator drugs to ensure a high degree of accuracy.
- To ensure no matrix interference and reproducible dilutional linearity, we run several serum and plasma spiking experiments at various dilutions to optimize. Additionally, our team ensures that precision is maintained at CV <10%.
Validated and Robust
- Validated against ICH / EMA guidelines under the ISO 13485 certification.
- Where available, validation of the kit against international standards from NIBSC / WHO
- 96 well plates with break apart strips includes lyophilized standards for stability.
- Expiry period of a minimum 10 months.
Performance Characteristics and Validation Information:
Sensitivity:The limit of detection is defined as the lowest detectable concentration corresponding to a signal of Mean of ‘0’ standard plus 2* SD. Each kit mentions sensitivity in the datasheet.
Calibration: Krishgen’s bsAb ELISA are calibrated against an internal calibration protocol to ensure accuracy.
Recovery and Matrix Effect:
Precision: Precision is defined as the percent coefficient of variation (%CV) i.e. standard deviation divided by the mean and multiplied by 100. Assay precision was determined by both intra and inter assay reproducibility on two pools with low, medium, and high concentrations. While actual precision may vary from laboratory to laboratory and technician to technician, it is recommended that all operators achieve precision below these design goals before reporting results.
World’s First
Krishgen’s range of Bispecific ELISA for measuring bispecific drugs is samples is the first in the world, and for many assays, we are the only company manufacturing them worldwide.
Related Research Areas
Related Blogs
Bispecific Antibody Drug Assays
BsAbs are divided into three categories according to their targets: (i) antibodies targeting two different tumor antigens; (ii) antibodies targeting one tumor antigen and one immune-related molecule; (iii) antibodies targeting two immune-related molecules. These three main bispecific antibody fragment formats are: bispecific T-cell engager (BiTE), dual-affinity re-targeting proteins (DARTs) and Tandem diabodies (TandAbs). BiTEs are connected by a linker molecule, which defines the flexibility of the construct and antigen-binding kinetics in conjunction with the specific antigens used. DARTs, on the other hand, have a similar basic structure but include a disulphide linker for additional stability. In the current research scenario. BiTE antibodies are under development with most major pharmaceutical companies for various oncology therapies.
Two other types of bsAbs: bispecific (BiKEs) and trispecific killer cell engagers (TriKEs) consist of either two (BiKE) or three (TriKE) variable antigen regions and activate natural killer cells either by binding to IL16 or containing an IL15 linker. A CD16xCD33 BiKE antibody is currently being studied for treatment of AML.
Since Bispecific antibodies have two different binding sites, their functionality can interfere with multiple surface receptors or ligands. They can also place targets into close proximity, either to support protein complex formation on one cell or trigger contact between cells. Their flexible functionality allows for four main mechanisms of action:
- Blocking immune checkpoints (a hot topic of research!)
- Activating immune cells
- Blocking dual signaling pathways
- Forcing association of protein complexes
Mode of Action of Therapeutic Bispecific Antibodies
Recruitment and Activation of Immune Cells:
Bispecific antibodies bind and activate immune cells at one binding site and recognize specific antigens on tumor cells at the other binding site, which mechanically recruit immune cells (e.g. T cells and NK cells) to the tumor area for killing. Examples include CD3×CD19 BsAbs, CD3×CD20 BsAbs, etc.
Blocking of Dual Signaling Pathways:
The onset and progression of diseases such as tumors usually involve multiple signals, and blocking a single signal may not completely inhibit tumor progression, and sometimes cause activation of other pathways. Bispecific antibodies work by targeting two receptors on the cell surface, inhibiting or activating two signals at the same time. Examples include PD-1 x CTLA-4 BsAbs, HER2 dual epitope BsAbs, etc.
Forcing Association Of Protein Complexes:
Bispecific antibodies can act on factors that are free in the body and promote the formation of protein complexes. A heterodimeric common light chain IgG connects FXIa and FX and thereby overcomes FVIII deficiency.
Products by Popular Bispecific Antibody Target Combinations
BsAb targeting CD3
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| Enzyme Immunoassay for the estimation of Acapatamab in serum and… |
BsAb targeting CD20
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| Enzyme Immunoassay for the estimation of Plamotamab in serum and… | ||
| Enzyme Immunoassay for the estimation of Epcoritamab in serum and… | ||
| Enzyme Immunoassay for the estimation of Glofitamab in serum and… | ||
| Enzyme Immunoassay for the estimation of Mosunetuzumab in serum and… |
BsAb targeting HER2 / HER3
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| Enzyme Immunoassay for the estimation of Istiratumab in serum and… | ||
| Enzyme Immunoassay for the estimation of Zenocutuzumab in serum and… | ||
| Enzyme Immunoassay for the estimation of Zanidatamab in serum and… | ||
| Enzyme Immunoassay for the estimation of Runimotamab in serum and… | ||
| Enzyme Immunoassay for the estimation of Cinrebafusp alfa in serum… |
BsAb targeting Interleukins
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| Enzyme Immunoassay for the estimation of Lutikizumab in serum and… |
BsAb targeting EGFR
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| Enzyme Immunoassay for the estimation of Amivantamab in serum and… |
BsAb targeting EpCAM
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| Enzyme Immunoassay for the estimation of Catumaxomab in serum and… | ||
| Enzyme Immunoassay for the estimation of Solitomab in serum and… |
If you are unable to locate your desired ELISA kit on our website, or have a technical query, please drop us a message and our team will come back to you with availability. If we do not have it available, we will suggest a feasible custom development option.
Require a Custom Assay?
Krishgen can develop and manufacture to your specific requirements.
Whether you require a change in the assay range or sensitivity, want an assay validated for a specific matrix or even want an novel immunoassay developed, the Krishgen team can support you. Get a free technical consultation to learn about the feasibility and timeline of your new assay.