- Monitoring Protein A leaching during antibody purification processes - Release and in-process testing of monoclonal antibody drug products - Process validation and clearance studies in downstream bioprocessing - Support for IND and BLA filing data packages
Product Overview :
This kit is designed 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 PLUS formulation offers an extended linear range and enhanced sensitivity for demanding analytical applications.
Features & Benefits :
- Broad detection spectrum covers natural and engineered recombinant Protein A variants - Extended dynamic range reduces the need for repeat dilutions - High sensitivity supports detection of trace-level residuals per regulatory guidelines - Compatible with samples derived from commonly used affinity purification resins
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