IBR Inc. provides end-to-end bioanalytical support, including assay development, validation, and sample analysis for pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and immunogenicity, including anti-drug antibody (ADA) assessments. Our expertise covers cytokines, chemokines, soluble and cellular biomarkers, drug–target interactions, and a broad range of functional and mechanistic cell-based assays.

We perform cell-based assays using primary cells, established and transfected cell lines, and reporter-gene systems, supported by diverse analytical readouts. Our technology platforms include Alpha Technology, time-resolved fluorescence (TRF), MSD® electrochemiluminescence (ECL), Gyrolab™, state-of-the-art flow cytometry and cytometric bead arrays, real-time PCR, alongside a broad portfolio of established analytical techniques.

In addition, IBR Inc. offers GMP-compliant analytical support for lot release testing within the approved scope, including methods for product identity, potency, and contamination testing.

All activities are performed under an integrated quality system aligned with applicable GLP, GCP, and GMP requirements and follow recognized regulatory and scientific standards, including ICH Q2 (R2), applicable elements of ICH M10, ICH E6 (R3), relevant USP chapters (<1032>, <1033>, <1034>), and EU GMP expectations, as appropriate to the study scope and regulatory context.