Protein A Residual Detection ELISA Kit

Cat.No. :

Kit-3967

Applications :

- Detection of Protein A leaching in purified antibody drug substances and drug products
- In-process and release testing per ICH Q6B specifications
- Biopharmaceutical product safety and purity evaluation
- Support for host cell protein and process-related impurity clearance studies

Product Overview :

This kit is intended for quantitative analysis of Protein A impurities in biopharmaceutical products. It detects both natural Protein A and recombinant Protein A variants, including alkali-resistant recombinant variants. The assay is suitable for routine quality control and process monitoring applications.

Features & Benefits :

- Validated detection of common natural and recombinant Protein A variants
- Reliable quantitative results with established accuracy and precision
- Fits standard 96-well ELISA workflow compatible with most laboratory instrumentation
- Supports compliance with regulatory expectations for residual impurity testing