Welcome to the home page for Immunoassay and Cell Based Assay Services.
BioReliance offers a wide range of immuno and cell based assays to support drug development throughout all stages of your product’s life cycle, from pre-clinical and clinical phases to lot release and stability testing. Our services support essential testing that establishes the safety and potency of biopharmaceuticals as well as determines pharmacokinetic profiles.
BioReliance offers the following Cell based and Immunoassay Services:
Numerous assay endpoint possibilities are supported by the following available technologies
BioReliance works with clients to develop, transfer, and validate custom assays to meet specific client needs and perform customized clinical sample analysis. With an experienced team of dedicated scientists and multiple technology platforms and offerings, we generate reliable data with quick turn around times to push your project forward.
Below you will find more information about each of our service areas as well as links to individual pages with additional details.
Potency assays measure product specific biological activity related to the mechanism of action (MOA) of the drug. Typically, biopotency is evaluated through cell based in vivo and in vitro assays as opposed to physical characterization techniques. At BioReliance, we have extensive experience developing as well as transferring and validating potency assays to support client needs in this essential step in the development and manufacture of biopharmaceuticals.
Immunogenicity testing is of vital importance in the development of therapeutic proteins. Anti-drug antibodies (ADA) triggered by therapeutics can cause changes in drug efficacy, pharmacokinetics and pose potential risk to patient safety. BioReliance provides a variety of assays, including traditional ELISA assays as well as Meso Scale Discovery (MSD) platforms, to give you a reliable overview of your therapeutic’s immunogenicity.
BioReliance has considerable experience in conducting immuno-based assays with both traditional ELISA methods and Meso Scale Discovery (MSD) technology. Whether you need a custom developed assay or a routine analysis, we provide multiple platforms to meet your assay requirements. With knowledgeable scientists and cutting edge technology, we are well positioned to provide you service that is fast, reliable, and guarantees that your product is safe and effective.
BioReliance provides neutralization assay development and validation services in support of biopharmaceutical development. Neutralization assays are routinely developed to detect and measure neutralizing antibodies (Nab) that can potentially interfere with, or may be required for, the therapeutic action of a biologic. These assays are custom developed for each unique biologic to provide a comprehensive approach to assay development and validation.
Host Cell Protein (HCP) Testing is critically important in the safety evaluation of biopharmaceuticals. Accurate identification and quantitation of HCPs is essential in minimizing the risk of potential immunogenicity effects to patients. BioReliance offers a wide variety of effective HCP assays to safeguard the purity and quality of your therapeutic from the preclinical development phase to customized assays suitable for later stage clinical studies.
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