IBR & Gyrolab^®

IBR Inc. is a fully independent, privately owned CRO with twenty years of operational experience and scientific excellence that enables them to offer an advanced panel of bioanalytical services. Their recent expansion of the bioanalytical business has included acquiring Gyrolab xPlore™ to meet new technical challenges, especially in immunogenicity evaluation and affinity measurements.

Gyrolab xPlore is one of the most recent additions to IBR Inc.’s growing range of technology platforms. The bioanalytical team has chosen Gyrolab system since they recognized the system’s ability to save time, miniaturize assays and deliver a broader dynamic range than conventional ELISA. These benefits make Gyrolab xPlore suitable for a broad range of applications, including:

• Pharmacokinetics and toxicokinetics
• Affinity determination and potency estimation of drug–target interactions
• Assessment of anti-drug antibodies (ADA) and drug-neutralizing antibodies (NAb) using the competitive ligand binding approach
• Monitoring of cytokines, chemokines and other biomarkers
• Detection of impurity levels

As René Moser, CEO and CSO, points out, “The ability of Gyrolab systems to generate reliable data based on small sample volumes is a clear advantage in preclinical studies using small research animals, but also in clinical studies since many biomarkers and chemical parameters need to be measured on the same sample.”

Immunogenicity is a particularly important area where they believe Gyrolab technology will offer them clear technical advantages, including high sensitivity, accuracy, robustness, reduced assay time and sample consumption, better drug- and target tolerance, dynamic range, and detection of low affinity anti-drug antibodies (ADA). They plan to use the system to offer their clients the possibility to generate safety data for ADA and drug-neutralizing antibodies (NAb) under GxP, thus making use of Gyrolab’s great advantages.

Laura Morra, Head of Innovation Bioanalytics, also highlighted another application area that they will be pursuing with Gyrolab technology: affinity measurements. “We really appreciate the versatility of Gyrolab xPlore, including its ability to determine the affinity of therapeutic antibodies and other biologicals. This will help us to meet increasing requests for support in the investigation of mechanism of action and potency.”

IBR Inc., Institute for Biopharmaceutical Research is a Swiss GxP-compliant contract research organization founded in 1998 (https://www.ibr-inc.com). We are a first-in-class site in the field of bioanalytical services for therapeutic antibodies, biologics, biosimilars, antibody-drug conjugates and vaccines covering the bioanalytical needs from pre-clinical to clinical development.

We are experienced in driving studies on cytokines, chemokines and other biomarkers, drug-target binding and immunogenicity. Furthermore, we perform cell-based assays with a broad variety of readouts. Our team has vast experience with primary cells, transformed cell lines, transfected cells, reporter-gene cell systems and 3D cell-based assays.

IBR Inc. moves on with rapid and constantly growing advances in technology and offers advanced platforms including Alpha Technology, Time Resolved Fluorescence (TRF), MSD® ECL, Gyrolab™, state-of-the-art Flow Cytometry/Cytometric Bead Array and real time PCR, beside a broad range of classical techniques.

With IBR Inc. your studies are supported from assay development to assay validation and sample measurement. We have capability to perform studies in compliance with regulatory guidelines for GLP and GCP quality standards, following the principles of ICH Q2 (R1), USP 1032, 1033 and 1034. Our study reports are compliant with eCTD requirements.

Find out more at www.ibr-inc.com