We use cookies to make your experience better. To comply with the new e-Privacy directive, we need to ask for your consent to set the cookies. Learn more.
GenScript Mmae Adc Pharmacokinetic Elisa Kit; 96Tests
List Price
$498.00
Your Price
$498.00
GenScript Mmae Adc Pharmacokinetic Elisa Kit - GSCRPT (Additional S&H or Hazmat Fees May Apply)
NETA PART:
GSCRPT-L00991
MFG.PART:
L00991
UNSPSC:
41116126
Manufacturer:
GenScript USA Inc
Overview
| Product Description | Monomethyl auristatin E (MMAE) is a synthetic antineoplastic agent. It inhibits cell division by blocking the polymerisation of tubulin.It is linked to a monoclonal antibody as a payload in MMAE conjugated antibody drug (MMAE-ADC) development [1-3]. There are several FDA approved MMAE-ADC drugs, such as Disitamab vedotin, Tivdak, Padcev, Polivy and Adcetris. MMAE-ADC can activate the antimitotic mechanism by cathepsin cleavage after it has entered a tumor cell, thus [4]. GenScript has comprehensively developed and validated the MMAE ADC Pharmacokinetic ELISA Kit for the quantitative measurement of MMAE-ADC in cynomolgus monkey serum and plasma. This kit is based on the ICH M10 and the FDA bioanalytical method validation guidance for industry, ensuring its precision, accuracy, dilutional linearity, specificity, selectivity, stability, and hook effect were acceptable [5-8]. The ELISA kit is a validated tool for MMAE-ADC quantification in biological matrices for drug research and development. |
Product Introduction
| LLOQ | 15.6 ng/mL | |||||||||||||||||||||||||||
| ULOQ | 1,000 ng/mL | |||||||||||||||||||||||||||
| Precision | Intra-assay: CV≤10% Inter-assay: CV≤15% | |||||||||||||||||||||||||||
| Minimum required dilution (MRD) | 1: 20, validated non-human primate plasma | |||||||||||||||||||||||||||
| Kit Contents |
| |||||||||||||||||||||||||||
| 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
| Assay Principle | MMAE ADC Pharmacokinetic ELISA Kit is a sandwich ELISA assay that utilizes an anti-MMAE monoclonal antibody as the capture antibody and an anti-human IgG monoclonal antibody as the detection antibody. When standards or samples are added to the capture plate, the anti-MMAE monoclonal antibody coating on the plate can capture the MMAE-ADC present in the sample. Then the Horseradish Peroxidase (HRP) conjugated Anti-human IgG monoclonal antibody is added to interact with the MMAE-ADC bound on the plate. After the washing steps, 3,3,5,5-Tetramethylbenzidine solution (TMB Solution) is added, resulting in the formation of blue color. The reaction is stopped by adding Stop Solution. Adding the Stop Solution changes the color from blue to yellow. The intensity of the color can be read at 450 nm and 630 nm by a microplate reader. The quantity of MMAE-ADC in the sample is accurately determined against a MMAE-ADC standard curve. |
| Reference | 1. Francisco JA, Cerveny CG, Meyer DL, et al. cAC10-vcMMAE, ananti-CD30-monomethyl auristatin E conjugate with potent and selective antitumoractivity. Blood. 2003 Aug 15;102(4):1458-65. Epub 2003 Apr 24. 2. Junutula JR, Raab H, Clark S, et al. Site-specificconjugation of a cytotoxic drug to an antibody improves the therapeutic index.Nat Biotechnol. 2008 Aug;26(8):925-32. 3. Doronina SO, Toki BE, Torgov MY, et al. Development of potent monoclonalantibody auristatin conjugates for cancer therapy. Nat Biotechnol. 2003Jul;21(7):778-84. 4. Joseph A Francisco 1, Charles G Cerveny, Damon L Meyer, et al. cAC10-vcMMAE,an anti-CD30-monomethyl auristatin E conjugate with potent and selectiveantitumor activity. Blood 2003 Aug 15;102(4):1458-65. 5. International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use. ICH Harmonised Guideline, Bioanalytical MethodValidation M10 (2019). 6. US FDA. Bioanalytical Method Validation Guidance for Industry (2018). 7. European Medicines Agency. Guideline on Bioanalytical Method Validation(2011). 8. |
For research use only. Not intended for human and animal therapeutic or diagnostic use.
| SKU | GSCRPT-L00991 |
|---|---|
| Supplier Part Number | L00991 |
| UM | EA |
| UNSPSC | 41116126 |
| Manufacturer | GenScript USA Inc |
| Temperature | 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. |
| ProductLine | GSCRPT |
| Qty | 1 |
| MinOrderQty | 1 |
| Weight | 7.000000 |
| Lead Time | 7 |
| Hazardous | Y |
| Energy Star | No |
| Green | No |
| Controlled | N |