| Product Description |
Pembrolizumab, with
the brand name Keytruda, is a humanized monoclonal antibody of IgG4 isotype. It
targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes, allowing
the immune system to destroy cancer cells. Pembrolizumab is an
immunotherapy drug. It is used for the treatment of patients with lung cancer,
head and neck cancer, and stomach cancer.
Antibody drugs have
the possibility to generate anti-drug antibodies (ADAs), which may alter drug
clearance and neutralize target binding, causing reduction of drug efficacy.
The immunogenicity of antibody drugs may cause anaphylaxis, infusion
reactions, and immune complex disorders. Pembrolizumab ADAs and its impact on
exposure, safety, and efficacy should be assessed. Analysis of pembrolizumab immunogenicity
is generally carried out with a multi-tiered testing approach, which consists
of screening tier, confirmation tier, and antibody titer assessment.
GenScript
Pembrolizumab Immunogenicity Kit (Bridging ELISA) is used for detection of
anti-Pembrolizumab antibody in serum and plasma samples. It is a validated
bridging immunoassay based on the FDA, EMA and NMPA Immunogenicity Guidelines[1-5].
The kit has been proved to be highly sensitive, specific, and free from matrix
effect in the validation study. It is suitable for the analysis of ADA against
Pembrolizumab. |
| Sensitivity |
1.56 ng/ml
|
| Detection Range |
1.56-50 ng/mL
|
| Precision |
Intra-assay≤10%
Inter-assay≤15%
|
| Minimum required dilution (MRD) |
1:5, validated non-human primate plasma
|
| Conveniency |
All reagents and buffers for the test are
provided and the test can be completed within 2.5 hours
|
| Kit Contents |
| Component |
Quantity/Size |
Part No. |
| Capture Plate |
1 plate |
K1-80 |
| Standard Stock |
1 vial (50 μL) |
K1-10 |
| 100×Biotin Pembrolizumab |
1 vial (100 μL) |
K1-20 |
| Streptavidin-HRP |
1 bottle (12 mL) |
K1-30 |
| Sample Dilution Buffer |
1 bottle (60 mL) |
K1-60 |
| 20×Wash Solution |
1 bottle (60 mL) |
K1-70 |
| Stop Solution |
1 bottle (6 mL) |
A1-50 |
| TMB Solution |
1 bottle (12 mL) |
A1-40 |
| Plate Sealer |
2 pieces |
N/A |
| User Manual |
1 piece |
N/A |
|
| Storage |
The
unopened kit is stable for at least 12 months from the date of manufacture at
2°C to 8°C, and the opened kit is stable for up to 1 month from the date of
opening at 2°C to 8°C. |
| Assay Principle |
GenScript Pembrolizumab Immunogenicity ELISA Kit
is a bridging immunoassay that contains a microplate coated with the
pembrolizumab. During the first incubation period, anti-Pembrolizumab antibody and biotin conjugated Pembrolizumab are added to
each well of the plate and then incubated at the same time. After a washing
step, horseradish peroxidase conjugated streptavidin is added and to react with
the TMB substrate to develop a blue product in the solution. The reaction is
stopped by adding stop solution, which turns the color yellow and the
absorbance can be read at 450 nm by a microplate reader. The intensity of the
reaction color is directly proportional to the concentration of antibodies to
pembrolizumab in samples.
|
| Reference |
1, ImmunogenicityTesting of Therapeutic Protein Products — Developing and Validating Assays forAnti-Drug Antibody Detection.
2, Immunogenicity of pembrolizumab in patients withadvanced tumors.
3, Technical Guideline on Immunogenicityof Therapeutic Agents,NMPA, 2021.03.
4, Immunogenicity Testing of Therapeutic ProteinProducts- Developing and Validating Assays for Anti-Drug Antibody DetectionGuidance for Industry, January 2019.
5, Guide line on Immunogenicity assessment of biotechnology-derivedtherapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1), 1st Dec 2017. |
Figure 1: Pembrolizumab Immunogenicity Kit (Bridging ELISA) standard curve.
Figure 2. MRD analysis of the Kit
For research use only.
Not intended for human and animal therapeutic or diagnostic use.
