Protein A ELISA Kit for Engineered Variant
R&D Systems, part of Bio-Techne | Catalog # BPPAEV0
Key Product Details
Assay Length
2.5 hours
Sample Type & Volume Required Per Well
Biosimilar Therapeutic Antibody (10 µL)
Sensitivity
0 pg/mL
Assay Range
23.4-1500 pg/mL (Biosimilar Therapeutic Antibody)
Product Summary for Protein A ELISA Kit for Engineered Variant
This Protein A ELISA is intended for detection of engineered Protein A constructs such as MabSelect SuRe™ in Bioprocess manufacturing applications. There are occasions where Protein A or its fragments leach from a purification column and remain bound to the Fc region of a therapeutic antibody. This must be avoided in order to preclude any adverse effects of Protein A on the patient, particularly in instances where antibodies are manufactured for pharmaceutical uses. This ELISA can be utilized as a Protein A ligand leaching quality control step in the mAb development workflow.
Product Specifications
Measurement
Quantitative ELISA
Detection Method
Colorimetric - 450nm (TMB)
Conjugate
HRP
Reactivity
N/A
Cross-reactivity
< 0.5% cross-reactivity observed with available related molecules. < 50% cross-species reactivity observed with species tested.
Interference
No significant interference observed with available related molecules.
Precision
Intra-Assay Precision (Precision within an assay) Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays) Three samples of known concentration were tested in twenty separate assays to assess inter-assay precision. Assays were performed by at least three technicians using two lots of components.
Biosimilar Therapeutic Antibody
| Intra-Assay Precision | Inter-Assay Precision | |||||
|---|---|---|---|---|---|---|
| Sample | 1 | 2 | 3 | 1 | 2 | 3 |
| n | 20 | 20 | 20 | 20 | 20 | 20 |
| Mean (pg/mL) | 70.0 | 227 | 725 | 77.7 | 239 | 753 |
| Standard Deviation | 1.70 | 6.54 | 26.6 | 6.58 | 10.3 | 28.4 |
| CV% | 2.4 | 2.9 | 3.7 | 8.5 | 4.3 | 3.8 |
Recovery for Protein A ELISA Kit for Engineered Variant
The recovery of Protein A Engineered Variant spiked into biosimilar therapeutic antibody samples to levels throughout the range of the assay was evaluated. Each user should qualify their sample matrices for accurate recovery. For sample matrices oth
| Sample Type | Average % Recovery | Range % |
|---|---|---|
| Biosimilar Therapeutic Antibody (n=4) | 96 | 84-122 |
Linearity
To assess the linearity of the assay, biosimilar therapeutic antibody samples spiked with high concentrations of Protein A Engineered Variant were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.
Scientific Data Images for Protein A ELISA Kit for Engineered Variant
Protein A Engineered Variant Standard Curve
Preparation and Storage
Shipping
The product is shipped at ambient temperature. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage
Store the unopened product at 2 - 8 °C. Do not use past expiration date.
Background: Protein A
Additional Protein A Products
Product Documents for Protein A ELISA Kit for Engineered Variant
Product Specific Notices for Protein A ELISA Kit for Engineered Variant
For research use only
Loading...
Loading...
Loading...