Therapeutic Drug Monitoring ELISA Kits

Therapeutic drug monitoring (TDM) is routinely implemented in inflammatory diseases to improve outcome and reduce treatment costs. TDM provides a means to test the pharmacokinetic (PK) and pharmacodynamic (PD) properties of a drug, providing more robust results in patient monitoring and experimental designs. TDM increases efficacy of response, decreases chance of toxicity and immunogenicity. It also allows for the detection of anti-drug antibodies (ADAs) that can occur with the use of biological therapeutics and hinder drug efficacy. Assay Genie provide a range of ELISA for detection and monitoring of therapeutic drugs and ADAs in serum and plasma samples of any animal for the World’s leading therapeutic antibodies.

These kits use the highest quality components and are manufactured under ISO 13485 quality systems.

Features

  • Quantitative ELISA kits for the measurement of the World’s leading therapeutic antibodies & biosimilars
  • Qualitative, quantitative & free/total kits enabling full screening of deleterious Anti-Drug Antibodies (ADAs)
  • Inter and intra assay CV meet requirements for FDA & EMEA
  • Premium quality validated Research-Use-Only ELISA manufactured in Europe under ISO 13485 quality systems
  • Validation, verification and lot release performed according to best-in-class scientific guidelines and literature
  • Use as little as 10ul sample per well – excellent for clinical, mouse, rat & primate samples
  • Get your results in as little as 55 minutes for some kits
  • All kits shipped at room temperature

Anti-Cancer

With high mortality and year on year increasing rates, developments of drugs to target different cancers are vital. Current therapeutic antibodies prevent angiogenesis, immune cell evasion and apoptosis inhibition and are used in lung cancer, colon cancer, glioblastomas, solid tumours, breast cancer, colorectal cancer and multiple myeloma.

Code Name ELISA Type
HUMB00022 Ramucirumab (Cyramza®) Free drug
HUMB00023 Anti-Ramucirumab (Cyramza®) ADA Antibody screening - Qualitative
HUMB00024 Bevacizumab (Avastin®) Free drug
HUMB00025 Anti-Bevacizumab (Avastin®) ADA Antibody screening - Qualitative
HUMB00026 Anti-Bevacizumab (Avastin®) ADA Antibody screening - Quantitative
HUMB00024 Rituximab (Rituxan®, Mabthera®) Free drug
HUMB00025 Anti-Rituximab (Rituxan®, Mabthera®) ADA Antibody screening - Qualitative
HUMB00026 Anti-Rituximab (Rituxan®, Mabthera®) ADA Antibody screening - Quantitative
HUMB00027 Rituximab (Rituxan®, Mabthera®) Free drug
HUMB00028 Anti-Rituximab (Rituxan®, Mabthera®) ADA Antibody screening - Qualitative
HUMB00029 Anti-Rituximab (Rituxan®, Mabthera®) ADA Antibody screening - Quantitative
HUMB00030 Trastuzumab ELISA Kit (Herceptin®/Herclon®) Free drug
HUMB00031 Anti-Trastuzumab (Herceptin®, Herclon®) ADA Antibody screening - Qualitative
HUMB00032 Anti-Trastuzumab (Herceptin®, Herclon®) ADA Antibody screening - Quantitative
HUMB00033 Cetuximab (Erbitux®) Free drug
HUMB00034 Anti-Cetuximab (Erbitux®) ADA Antibody screening - Qualitative
HUMB00035 Anti-Cetuximab (Erbitux®) ADA Antibody screening - Quantitative
HUMB00054 Aflibercept (Eylea®) Free drug
HUMB00055 Aflibercept (Eylea®) ADA Antibody screening - Qualitative
HUMB00062 Daratumumab (Darzalex®) Free drug
HUMB00063 Daratumumab (Darzalex®) ADA Antibody screening - Qualitative

Checkpoint Inhibitors

Increasing knowledge of how tumours undergo immune evasion has led to the discovery of drugs called checkpoint inhibitors. These immunotherapies can prevent this override of the immune system, and allow the cancer to be detected and destroyed. These biologics are currently used to treat Merkel Cell Carcinoma (MCC), Melanoma, lung cancer, renal cell carcinoma and head and neck cancer.

Code Name ELISA Type
HUMB00042 Avelumab (Bavencio®) Free drug
HUMB00043 Anti-Avelumab (Bavencio®) ADA Antibody screening - Qualitative
HUMB00044 Nivolumab (Opdivo®) Free drug
HUMB00045 Anti-Nivolumab (Opdivo®) ADA Antibody screening - Qualitative
HUMB00046 Pembrolizumab (Keytruda®) Free drug
HUMB00047 Anti-Pembrolizumab (Keytruda®) ADA Antibody screening - Qualitative
HUMB00048 Ipilimumab (Yervoy®) Free drug
HUMB00049 Anti-Ipilimumab (Yervoy®) ADA Antibody screening - Qualitative
HUMB00058 Durvalumab (Imfinzi®) Free drug
HUMB00059 Durvalumab (Imfinzi®) ADA Antibody screening - Qualitative
HUMB00060 Atezolizumab (Tecentriq®) Free drug
HUMB00061 Atezolizumab (Tecentriq®) ADA Antibody screening - Qualitative

Anti-Inflammatory

While providing us defence against pathogens, the immune response can also turn inwards and trigger autoimmune disorders. Knowledge of the biochemical pathways involved in inflammation has allowed researchers to target specific agents with therapeutic antibodies/biologics to decrease disease burden, such as arthritis, inflammatory bowel disease, psoriasis, muckle wells disease and many more.

Code Name ELISA Type
HUMB00018 Vedolizumab (Entyvio®) ELISA Kit Free drug
HUMB00019 Anti-Vedolizumab (Entyvio®) ADA Qualitative ELISA Kit Antibody screening - Qualitative
HUMB00020 Ustekinumab (Stelara®) Free drug
HUMB00021 Anti-Ustekinumab (Stelara®) ADA Antibody screening - Qualitative
HUMB00050 Tocilizumab (Actemra®) Free drug
HUMB00051 Anti-Tocilizumab (Actemra®) Antibody screening - Qualitative
HUMB00052 Natalizumab (Tysabri®) Free drug
HUMB00053 Anti-Natalizumab (Tysabri®) ADA Antibody screening - Qualitative
HUMB00056 Canakinumab (Ilaris®) Free drug
HUMB00057 Anti-Canakinumab (Ilaris®) ADA Antibody screening - Qualitative
HUMB00068 Abatacept (Orencia®) Free drug
HUMB00069 Anti-Abatacept (Orencia®) ADA Antibody screening - Qualitative
HUMB00066 Secukinumab (Cosentyx® , Verxant®) Free drug
HUMB00067 Anti-Secukinumab (Cosentyx® , Verxant®) ADA Antibody screening - Qualitative

Anti-TNFα

Dysregulation in TNFα signalling is a common occurrence in inflammatory disorders. Thus, a range of therapeutic antibodies have been developed to treat a number of pathologies such as; rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis. Using TDM for these antibodies during treatment is of great benefit in monitoring patient response, optimising dosage and preventing immunogenicity.

Code Name ELISA Type
HUMB00001 Infliximab (Remicade®) Free drug
HUMB00002 Anti-Infliximab (Remicade®) ADA Antibody screening - Qualitative
HUMB00003 Anti-Infliximab (Remicade®) ADA Antibody screening - Quantitative
HUMB00004 Anti-Infliximab (Remicade®) Free Drug/ADA Dual ELISA Antibody screening - Free/Total semiquantitative
HUMB00005 Infliximab (Remsima®) Free drug
HUMB00006 Anti-Infliximab (Remsima®) ADA Antibody screening - Qualitative
HUMB00007 Anti-Infliximab (Remsima®) ADA Antibody screening - Quantitative
HUMB00008 Anti-Infliximab (Remsima®) ADA Antibody screening - Total semiquantitative
HUMB00009 Adalimumab (Humira®) Free drug
HUMB00010 Anti-Adalimumab (Humira®) ADA Antibody screening - Qualitative
HUMB00011 Anti-Adalimumab (Humira®) ADA Antibody screening - Quantitative
HUMB00012 Anti-Adalimumab (Humira®) Free Drug/ADA Dual ELISA Antibody screening - Free/Total semiquantitative
HUMB00013 Etanercept (Enbrel®) Free drug
HUMB00014 Anti-Etanercept (Enbrel®) ADA Antibody screening - Qualitative
HUMB00015 Golimumab (Simponi®) Free drug
HUMB00016 Anti-Golimumab (Simponi®) ADA Antibody screening - Qualitative
HUMB00017 Certolizumab (Cimzia®) Free drug

Wet AMD

Macular degeneration is a debilitating illness of the eye that ultimately releases in loss of central vision. Most treatments involve biologics that target VEGF or its receptors to prevent damaging angiogenesis.

Code Name ELISA Type
HUMB00041 Ranibizumab (Lucentis®) ELISA Kit Free drug
HUMB00024 Bevacizumab (Avastin®) ELISA Kit Free drug
HUMB00025 Anti-Bevacizumab (Avastin®) ADA Antibody screening - Qualitative
HUMB00026 Anti-Bevacizumab (Avastin®) ADA Antibody screening - Quantitative
HUMB00041 Ranibizumab (Lucentis®) free drug
HUMB00054 Aflibercept (Eylea®) Free drug
HUMB00055 Aflibercept (Eylea®) ADA Antibody screening - Qualitative

Anti-Allergy and Asthma

Incidences of allergy and allergic asthma are on the rise worldwide. Treatments for asthma focus on treating the secondary symptoms. Biologics have been created to bind to free IgE in the treatment of asthmatics who are unresponsive to corticosteroids.

Code Name ELISA Type
HUMB00039 Omalizumab (Xolair®) Free drug
HUMB00040 Anti-Omalizumab (Xolair®) ADA Antibody screening - Qualitative

Immune Stimulation

Neutropenia refers to an abnormally low concentration of neutrophils in the blood, and can result in a range of harmful side effects that is commonly seen in patients receiving chemotherapy and HIV. It can be treated with exogenous G-CSF.

Code Name ELISA Type
HUMB00038 Anti-Filgrastim ADA Antibody screening - Quantitative

Obesity

Biologics have been developed to combat obesity that present with hyperlypidemia to allow LDL to be removed from the blood.

Code Name ELISA Type
HUMB00064 Evolocumab (Repatha® ) Free drug
HUMB00065 Evolocumab (Repatha® ) ADA Antibody screening - Qualitative

Osteoporosis

With age and hormone changes, alterations occur in bone homeostasis that lead to degeneration of bone cells. By targeting RANK-L, it is possible to prevent the growth of osteoclasts that breakdown bone.

Code Name ELISA Type
HUMB00036 Denosumab (Prolia®) Free drug
HUMB00037 Anti-Denosumab (Prolia®) ADA Antibody screening - Qualitative

Therapeutic Antibody Monitoring (TDM) ELISA Kits - Key Information

Therapeutic Drug Monitoring (TDM)

Our range of ELISA kits have many applications, for example in therapeutic drug (antibody) monitoring (TDM). TDM is the clinical practice of measuring specific drugs at designated intervals in order to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens.

TDM kits allow clinicians to adjust therapeutic antibody dose according to the individual pharmacokinetic characteristics of each patient. The optimal therapeutic concentration can therefore be achieved more rapidly while minimizing drug toxicity. Additionally, TDM can help to identify problems with medication compliance among non-compliant patient cases.

Key Therapeutic Drug Monitoring ELISA Kits

Assay Genie Anti-Drug Antibody (ADA) ELISA Kits

As with almost all biologics, therapeutic antibodies can produce an immune response which leads to the production of anti-drug antibodies (ADA). Most ADA responses to therapeutic monoclonal antibodies (mAbs) are directed against the antigen-binding site of the biologic, and hence are neutralizing. This anti-drug antibody response explains why even fully human antibodies can still be highly immunogenic.

Anti-drug antibodies cause undesired immunogenicity, which can reduce the therapeutic effects of the biologic treatment. ADAs can also result in unwanted adverse effects in some cases. Detecting and monitoring the level of anti-drug antibodies can be of high importance when assessing adverse drug reactions. Assay Genie provides a range of immunogenicity assays for anti-drug antibody (ADA) analysis.

Key Anti-Drug Antibody ELISA Kits

Assay Genie Biosimilar ELISA Kits

A biosimilar is a biologic product with highly similar quality, safety and efficacy characteristics to an already approved biotechnological product (reference product). There are no clinically meaningful differences between the biosimilar and the reference biologic in terms of these product standards. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products are being developed or have already been approved for human use.

Like all biologics, biosimilars are structurally complex proteins that are typically manufactured using genetically engineered animal, bacterial or plant cell culture systems. As a consequence of this molecular complexity and the proprietary nature of the manufacturing process, which will inevitably result in the use of different host cell lines and expression systems as well as related differences in manufacturing conditions, it is not possible to manufacture exact copies of a reference biologic.

Assay Genie Biosimilar ELISA Kits are highly specific and sensitive assays, designed for the in vitro detection and quantification of therapeutic antibodies in biological samples including both serum and plasma. We offer a range of research-level biosimilar therapeutic antibodies and ELISA kits for your experimentation needs.

Check out our Ebook which provides and overview of the top 10 biologics and key information regarding their application, mode of action and biosimilars.

Advantages of Assay Genie Therapeutic Drug Monitoring (TDM) Kits

Advantages Description

Rapid, Simple and Inexpensive

No expensive equipment or special handling required

Highly Sensitive and Specific

No significant cross-reactivity or interface with other proteins present in native human serum or other therapeutic immunoglobulins

Accurate

Low intra and inter-assay variability

Cost savings

Can lead to the discontinuation of ineffective biologic treatments

Therapeutic Drug Monitoring ELISA (TDM) Sample Protocol

Steps Protocol

1

Pipette 100µl of Assay Buffer non-exceptionally into each of the wells to be used.

2

Pipette 10 µL of each ready-to use Standards, High Level Control, Low Level Control and Diluted Samples into the respective wells of microtiter plate.

Wells
A1: Standard A
B1: Standard B
C1: Standard C
D1: Standard D
E1: Standard E
F1: High Level Control
G1: Low Level Control
H1 and on: Sample (Serum / Plasma)

3

Cover the plate with adhesive foil. Incubate 30 min at room temperature (18- 25°C).

4

Remove adhesive foil. Discard incubation solution. Wash plate 3 times each with 300µL of diluted. Wash Buffer. Remove excess solution by tapping the inverted plate on a paper towel.

5

Pipette 100 µL of ready-to use HRP-Conjugated Probe into each well.

6

Cover the plate with adhesive foil. Incubate 30 min at room temperature (18- 25°C).

7

Remove adhesive foil. Discard incubation solution. Wash plate 3 times each with 300 µL of diluted Wash Buffer. Remove excess solution by tapping the inverted plate on a paper towel.

8

Pipette 100 µL of TMB Substrate Solution into each well.

9

Incubate 10 min (without adhesive foil) at room temperature (18-25°C) in the dark

10

Stop the substrate reaction by adding 100 µL of Stop Solution into each well. Briefly mix contents by gently shaking the plate. Colour changes from blue to yellow.

11

Measure optical density with a photometer at 450/650 nm within 30 min after pipetting of the Stop Solution.

Figure 1: Overview of Sample Preparation for Therapeutic Drug Monitoring (TDM) ELISA Kits

Figure 2: Schematic of Theraputic Drug Monitoring (TDM) ELISA kit protocol


Detection Strategies for Therapeutic Drug Monitoring ELISA Kits

The detection step in an ELISA is last step to measure the amount of analyte that you have in your sample. The signal generated during the detection step is proportional to the amount of analyte bound.

Chromogenic is the most popular and most widely used technique for ELISA detection and involves the horse radish peroxidase (HRP) substrate TMB (3, 3’, 5, 5’-tetramethylbenzidine) which yields a blue colour when oxidized and turns to yellow following the addition of sulphuric acid. Which allows samples to be read at 450nm on an ELISA plate reader.

Calculating the results using the following equation:

The relative O.D.450 = (the O.D.450 of each well) – (the O.D.450 of Zero well)

The standard curve can be plotted as the relative O.D.450 of each standard solution (Y) vs. the respective concentration of the standard solution (X). The concentration of the samples can be determined from the standard curve. It is recommended to use professional software such as curve expert 1.3.

FAQs

How should my ELISA Kit be stored?

The kit is shipped at ambient temperature (10-30°C) and should be stored at 2-8°C for long term storage. Keep away from heat or direct sunlight.

There was a weak/no signal in my ELISA results, what could have caused this?

Possible cause Possible solution

Reagents not at room temperature

All reagents should at room temperature from the start of the assay. Room temperature should be reached following 15–20 minutes on the bench.

Incubation time too short

Follow manufacturer guidelines in the technical manuals

Incorrect wavelength

Manufactured kits have optimized protocols. Make sure to use recommended wavelength. Ensure plate reader is set accurately for type of substrate being used

Target present below detection limits of assay

Decrease dilution factor or concentrate samples

Poor standard curve in results?

For more ELISA troubleshooting tips click here

Reagents are poorly mixed, the standard has degraded or pipetting errors.

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