High-Sensitivity Residual Protein A Detection Kit Empowering the Whole Quality Control Workflow of Antibody Drugs

In the industrial production of monoclonal antibodies, Fc fusion proteins and other biotherapeutics, Protein A affinity chromatography serves as the core purification process. However, leached residual Protein A will directly affect the safety and efficacy of drugs, making it a critical testing item for in-process quality control and batch release.Our Universal Test Kit for Residual Protein A is developed based on the double-antibody sandwich ELISA principle. Featuring ultra-high sensitivity, wide compatibility and streamlined operation, it delivers a compliant, accurate and efficient solution for residual detection. It helps biopharmaceutical enterprises strictly control quality risks, accelerate R&D progress and improve production and delivery efficiency.🧪

🌟Core Advantages — Leading Quality Control Detection

1. Ultra-high Sensitivity for Trace Residue Tracing 📈

Adopting a high-specificity antibody pairing system, it is fully compatible with mainstream commercial affinity chromatography media. The limit of quantitation (LOQ) is as low as 10 pg/mL, with spike recovery ranging from 80% to 120%. It fully meets the stringent specifications for trace residue detection of biotherapeutics stipulated in the Chinese Pharmacopoeia and regulatory requirements of Europe, America and other global authorities, delivering accurate assurance for enterprise trace residue testing.

2. Wide Compatibility for Full-scenario Coverage🌐

No separate adaptation for different brands of chromatography media is required. Equipped with universal reference standards as well as exclusive standards for mainstream ligands, it is fully compatible with Protein A affinity resins from mainstream brands at home and abroad including Cytiva, Merck, Nano-Micro and Sepax.

It is applicable to in-process monitoring, intermediate testing and final batch release testing of therapeutic antibodies and Fc fusion proteins. One kit for multiple applications greatly reduces corporate procurement, validation and labor costs.

3. Simple & Efficient Operation Adapted to High-throughput QC⏱️

Complicated sample pretreatment procedures required by conventional methods such as high-temperature boiling, protein denaturation and repeated centrifugation are eliminated. Routine samples can be loaded directly after appropriate dilution.

The overall assay time is within 2 hours. Adopting a 96-well plate format, it supports parallel batch testing, effectively shortening the experimental cycle and reducing human operational errors. It perfectly adapts to large-scale biopharmaceutical production and daily high-throughput quality control scenarios, helping enterprises improve QC efficiency.

4. Traceable Compliance with Stable & Reliable Data🛡️

Core raw materials are independently developed and self-controlled with excellent inter-batch variation, outstanding batch stability and reproducibility.

The methodology has been verified in laboratories of multiple biopharmaceutical enterprises. A complete package of methodological validation documents is provided to fully meet the compliance requirements for R&D, production and drug registration declaration worldwide, escorting enterprise compliant quality control.

📋Application Scenarios

• 🔬Process optimization testing for monoclonal antibodies, bispecific antibodies, Fc fusion proteins and other biotherapeutics in the R&D stage;
• 🧫Real-time monitoring of residual Protein A in chromatographic eluates and intermediates during production;
• ✅Final product release testing to ensure residual levels comply with pharmacopoeia and regulatory standards;
• 📊Routine testing and method validation demands of research institutions, CDMOs and QC laboratories of pharmaceutical enterprises.