Our Tiered Data-Driven ELISA CDMO Optimization Workflow
Our dedicated ELISA platform addresses every core limitation of conventional in-house assay development via a tiered, data-driven antibody & immunoassay engineering pipeline built exclusively for IVD CDMO clients. We begin with target epitope mapping and clone screening across our fully traceable antibody library, isolating high-affinity capture and detection pairs pre-screened against common matrix interferents. Next, our immunochemistry team optimizes solid-phase microplate coating buffers, blocking formulations, and HRP/AP conjugate conjugation chemistry to minimize off-target binding and maximize signal amplitude.
We deploy automated liquid handler high-throughput assay screening to test hundreds of parameter combinations in parallel—incubation times, pH gradients, salt concentrations, wash stringency, and substrate chemistries—cutting manual lab trial timelines by over 60%. Every prototype ELISA undergoes full analytical performance validation (limit of detection, limit of quantitation, linear range, precision, spike recovery, cross-reactivity, shelf-life stability) aligned with ISO 13485 and IVD regulatory guidelines (FDA, CE-IVD, NMPA). This standardized, compliant development framework delivers a robust, transferable ELISA workflow ready for pilot scale-up and commercial kit manufacturing without downstream re-optimization.
For global diagnostic partners without in-house immunology teams, we deliver a fully turnkey solution: target antigen production → antibody generation & purification → assay optimization → analytical validation → GMP transfer manufacturing, eliminating fragmented third-party vendor coordination.
