Therapeutic Drug Monitoring ELISA Kits

Therapeutic Drug Monitoring (TDM) ELISA Kits

Therapeutic Antibody Monitoring (TDM) ELISA Kits - Key Information

The ELISA Genie Therapeutic Antibody, Biosimilar & Anti-Drug Antibody (ADA) ELISA kits are a premium range of kits designed to detect free therapeutic antibodies, biosimilars and Anti-Drug Antibodies in serum & plasma samples. ELISA Genie Therapeutic Drug Monitoring ELISA Kits provide quantitative ELISA kits for the measurement of the World’s leading therapeutic antibodies & biosimilars.

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

Premium Quality Validated Assays

  • Manufactured in Europe under ISO 13485 quality systems
  • Kits for Research-Use-Only
  • Inter and intra assay CV meet requirements for FDA & EMEA
  • Validation, verification and lot release performed according to best-in-class scientific guidelines and literature

Quantitative & Qualitative Screening Kits

  • Quantitative ELISA kits for the measurement of the World’s leading
    therapeutic antibodies & biosimilars
  • Qualitative kits enabling the screening of deleterious ADAs
  • Dual kits allowing for the screening of ADAs and free therapeutic antibodies


Optimized Format & Protocol

  • 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

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

ELISA 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. ELISA Genie provides a range of immunogenicity assays for anti-drug antibody (ADA) analysis.

Key Anti-Drug Antibody ELISA Kits

ELISA 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.

ELISA 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 ELISA 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

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


Therapeutic Drug Monitoring ELISA (TDM) Step-By-Step

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


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.

Therapeutic Drug Monitoring ELISA Kits 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?

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

For more ELISA troubleshooting tips click here

Therapeutic Drug Monitoring ELISA Kits

Code Product Total Time (min)

HUMB00001

70

HUMB00002

140

HUMB00003

140

HUMB00004

95

HUMB00005

70

HUMB00006

140

HUMB00007

140

HUMB00008

95

HUMB00009

70

HUMB00010

140

HUMB00011

140

HUMB00012

95

HUMB00013

70

HUMB00014

140

HUMB00015

70

HUMB00016

140

HUMB00017

70

HUMB00018

140

HUMB00019

140

HUMB00020

70

HUMB00021

140

HUMB00022

70

HUMB00023

140

HUMB00024

70

HUMB00025

140

HUMB00026

140

HUMB00027

135

HUMB00028

140

HUMB00029

140

HUMB00030

70

HUMB00031

140

HUMB00032

140

HUMB00033

70

HUMB00034

140

HUMB00035

140

HUMB00036

70

HUMB00037

140

HUMB00038

140

HUMB00039

70

HUMB00040

140

HUMB00041

70

HUMB00042

70

HUMB00043

140

HUMB00044

70

HUMB00045

140

HUMB00046

140

HUMB00047

140

HUMB00048

70

HUMB00049

140