Anti-Ramucirumab ELISA Kit

Sample

Serum, plasma

Species Reactivity

Human

Detection Method

sELISA

Intended Use

Qualitative Antibodies to Ramucirumab ELSA has been especially developed for the qualitative analysis of antibodies to ramucirumab in serum and plasma samples.

Contents of Kit

1. Microtiter Plate: 1 × 12 × 8
Break apart strips. Microtiter plate with 12 rows each of 8 wells coated with ramucirumab.
2. Controls 1.0 mL (negative); 1.0 mL (positive)
Ready to use. Contains human serum and stabilizer, <0.1% NaN₃.
3. Assay Buffer 1 × 50 mL
Ready to use. Blue coloured. Contains proteins, <0.1% NaN₃.
4. Conjugate 1 × 12 mL
Horse radish peroxidase conjugated probe. Ready to use. Red coloured. Contains HRP conjugated probe, stabilizer and preservatives.
5. Substrate 1 × 12 mL
TMB substrate solution Ready to use. Contains 3,3´,5,5´-Tetramethylbenzidine (TMB).
6. Stop Buffer 1 × 12 mL
TMB stop solution. Ready to use. 1N HCl.
7. Wash Buffer 1 × 50 mL
Prepared concentrated (20×) and should be diluted with the dilution rate given in the "Reagent Preparation" before the test. Contains buffer with tween 20.
8. Foil 2 × 1
Adhesive Foil. For covering microtiter plate during incubation.

Storage

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. The strips of microtiter plate are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2-8°C.

Precision

Intra-assay and inter-assay CVs <30%

General Description

Ramucirumab is a human monoclonal antibody (IgG1) against vascular endothelial growth factor receptor 2 (VEGFR2), a type II trans-membrane tyrosine kinase receptor expressed on endothelial cells. By binding to VEGFR2, ramucirumab prevents binding of its ligands (VEGF-A, VEGF-C, and VEGF-D), thereby preventing VEGF-stimulated receptor phosphorylation and downstream ligand-induced proliferation, permeability, and migration of human endothelial cells. VEGFR stimulation also mediates downstream signalling required for angiogenesis and is postulated to be heavily involved in cancer progression, making it a highly likely drug target. In contrast to other agents directed against VEGFR-2, ramucirumab binds a specific epitope on the extracellular domain of VEGFR-2, thereby blocking all VEGF ligands from binding to it.
Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. The indications for drug monitoring include efficacy, compliance, drug-drug interactions, toxicity avoidance, and therapy cessation monitoring. Additionally, TDM can help to identify problems with medication compliance among noncompliant patient cases.
Biologic medicinal products (biologics) have transformed treatment landscapes worldwide for patients with haematological or solid malignancies with the 21st century. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products (i.e., biologics that are considered to be similar in terms of quality, safety and efficacy to an approved 'reference' biologic) 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.
When administered to patients, all therapeutic proteins have the potential to induce an unwanted immune response (i.e., to stimulate the formation of antidrug antibodies [ADAs]). The impact of immune responses can range from no apparent effect to changes in pharmacokinetics, loss of effect and serious adverse events. Furthermore, the immunogenicity profile of a biologic can be significantly altered by even small differences in its manufacturing process that are accompanied by a change in product attributes, as well as differences in dosing schedules, administration routes or patient populations.

General Notes

Ramucirumab is a human monoclonal antibody (IgG1) against vascular endothelial growth factor receptor 2 (VEGFR2), a type II trans-membrane tyrosine kinase receptor expressed on endothelial cells. By binding to VEGFR2, ramucirumab prevents binding of its ligands (VEGF-A, VEGF-C, and VEGF-D), thereby preventing VEGF-stimulated receptor phosphorylation and downstream ligand-induced proliferation, permeability, and migration of human endothelial cells. VEGFR stimulation also mediates downstream signalling required for angiogenesis and is postulated to be heavily involved in cancer progression, making it a highly likely drug target. In contrast to other agents directed against VEGFR-2, ramucirumab binds a specific epitope on the extracellular domain of VEGFR-2, thereby blocking all VEGF ligands from binding to it.
Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. The indications for drug monitoring include efficacy, compliance, drug-drug interactions, toxicity avoidance, and therapy cessation monitoring. Additionally, TDM can help to identify problems with medication compliance among noncompliant patient cases.
Biologic medicinal products (biologics) have transformed treatment landscapes worldwide for patients with haematological or solid malignancies with the 21st century. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products (i.e., biologics that are considered to be similar in terms of quality, safety and efficacy to an approved 'reference' biologic) 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.
When administered to patients, all therapeutic proteins have the potential to induce an unwanted immune response (i.e., to stimulate the formation of antidrug antibodies [ADAs]). The impact of immune responses can range from no apparent effect to changes in pharmacokinetics, loss of effect and serious adverse events. Furthermore, the immunogenicity profile of a biologic can be significantly altered by even small differences in its manufacturing process that are accompanied by a change in product attributes, as well as differences in dosing schedules, administration routes or patient populations.