Exogenous / Endogenous Standards
Single B-cell Antibody Pair Screening
Method Development and Validation
Method Transfer to GLP/GCP Laboratories
Antibody Pair Screening: Select biologically active antigens as immunogens; high-throughput single B-cell screening potentially improves sensitivity and specificity compared to traditional methods, accelerating R&D efficiency.
Assay Development & Validation: Fit-for-purpose biomarker assay development and full validation.
Multi-Platform Support: ELISA / FACS / TR-FRET / IHC covering cells, blood, and tissues.
Kit Production: GMP-compliant manufacturing with full IVD-grade quality control achieves batch-to-batch variation ≤8%.
RUO-to-IVD Transition: Professional regulatory support aims to expedite the FDA/CE certification process.



