High Sensitivity, Easy Operation | Hyasen Universal Test Kit for Residual Protein A

Native Protein A is isolated from Staphylococcus aureus (type A). By leveraging its property of high-affinity binding to the Fc region under neutral conditions and dissociation under acidic conditions, Protein A immobilized on a solid support is widely used for the industrial purification of therapeutic antibodies.

Inevitably, Protein A may leach during antibody purification, leading to residual Protein A in antibody drugs and rendering it a process-related impurity.

The Hyasen Universal Test Kit for Residual Protein A features excellent accuracy, precision and linearity. It can be applied to in-process control and release testing of residual Protein A in therapeutic antibodies and Fc-fusion proteins, fully meeting the requirements for marketing authorization applications of corresponding protein pharmaceuticals.

• Linear range: 10-640 pg/mL，R² > 0.990
• LOQ: 10 pg/mL
• Specificity:In the presence of 0.1 μg/mL HCP and 0.1 ng/mL HCD, Specificity recovery rate of 10 pg/mL protein A is 82.2%
• Accuracy: The recovery rate of spiked samples is within 80-120%.
• Precision: Both intra-assay and inter-assay precision are less than 15%.