Sample
Biopharmaceutical samples
Detection Method
Sandwich-ELISA
Intended Use
This product is a universal detection kit used for quantitative detection of residue Alkali Resistant Protein A (MabSelect SuReTM Protein A) concentration in biopharmaceutical samples.
Contents of Kit
| No. | Components | Size | Storage Conditions |
| 1 | Protein A Microwell Plate | 12×8 | 2-8°C |
| 2 | Alkali-Resistant Protein A Standard | 3 vials, lyophilized | 2-8°C |
| 3 | Protein A 100× HRP-Antibody | 2×30 μL | 2-8°C. |
| 4 | Assay Diluent | 2×25 mL | 2-8°C. |
| 5 | 20× Wash Buffer Concentrate | 30 mL | 2-8°C. |
| 6 | Substrate Solution | 12 mL | 2-8°C in the dark. |
| 7 | Stop Solution | 12 mL | 2-8°C. |
| 8 | Adhesive plate cover | 2 sheets | |
Storage
Stored at 2-8°C until the expiration date.
Precision
Intra-assay Precision (Precision within an assay): ≤10%. Inter-assay Precision (Precision between assays) : ≤10%.
Sensitivity
LOD: 6.6 pg/mL
LOQ: 13.7 pg/mL
General Description
Protein A affinity chromatography resin is a commonly used tool for separating and purifying antibodies in the production and purification process of antibody products. However, during the antibody purification process, Protein A may leach, resulting in the presence of Protein A in the antibody products, which affects the purity and potency of the products and brings significant problems to the pharmaceutical industry.
Protein A includes natural Protein A, recombinant Protein A, and alkali resistant recombinant Protein A with significantly different structures from natural Protein A, such as GE's MabSelect SuReTM Protein A.
Standard Curve
This standard curve is for demonstration only. A standard curve must be generated for each assay.


Citations
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