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™ (https://www.ibr-inc.com/gyrolab/) 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:
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. present themselves:
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
The recent outbreak of the novel coronavirus disease (COVID-19) has resulted in a worldwide pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Efforts to slow the spread of the virus and to develop vaccines and treatments require SARS-CoV-2 antibody testing. To meet this need, we have developed a Gyrolab immunoassay for qualitative detection of total antibodies generated against the receptor binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in human serum samples.
Protein biomarkers are utilized in all phases of the drug development process from discovery to clinical studies to evaluate a drug’s effectiveness or potential toxicity. Immunoassays remain the most selective, specific, and sensitive method to determine protein biomarker levels. However, the development of these assays can be challenging due to the high sensitivity required and serum matrix interference.
We have developed immunoassays with supporting data to provide a foundation to speed up your biomarker immunoassay development.
As biologic drugs come off-patent and biosimilar versions become available it is vital to ensure that the biosimilars have similar PK, efficacy, and safety profiles to their branded equivalents. The equivalence of biosimilars is a point of concern since the tight relationship between structure and function of biologics means that pharmacology can be affected by even minor changes during the manufacturing process. We have therefore developed a set of robust Gyrolab PK assay protocols to support the development of biosimilars from nonclinical to human clinical studies.
A key requirement in biopharmaceutical manufacturing is the development of a robust, sensitive, and high-quality bioanalytical method for the detection of impurities that inevitably carry over from the production process. These impurities can originate from the culture media or additives, from the purification process such as protein A leaching from a purification column, or from the host cells. The presence of host cell proteins (HCPs) is of particular concern, as these contaminants pose an immunogenicity reaction risk to the patients.
To assist with the development of immunoassays for bioprocess impurity analysis, we have developed robust assay protocols to determine process-related impurities in bioprocessing samples.
Measuring anti-drug antibody (ADA) levels is an essential part of developing new biologics. The clinical implication of the presence of anti-drug-antibodies in treated patients may include allergic reactions, immune complex toxicity, autoimmune reactions and reduction of efficacy.
Recently regulatory agencies have lowered the sensitivity requirement for ADA detection, from 250-500 ng/mL to 100 ng/mL. To reach such sensitivity levels without affecting the assay drug tolerance, sample pre-treatment steps may be necessary. Gyrolab ADA Solution streamlines ADA assay workflows and automates acid dissociation steps to improve sensitivity and drug tolerance of ADA assays while reducing variability and saving time. ADA assays can also be developed using overnight incubation protocols to dissociate the drug-ADA complexes prior to determination of ADA levels in clinical samples using Gyrolab Bioaffy 200 or 1000 CD.
To meet the needs of immunogenicity evaluation during biotherapeutic development, we have developed Gyrolab protocols to determine ADAs in clinical or preclinical samples that have been treated with marketed biopharmaceuticals.