As the long-term pioneer as well as market leader in the field of therapeutic antibody development, Creative Biolabs has successfully established and commercialized a wide spectrum of functional assays to illustrate antibody bioactivity and mechanism of action. Particularly, we offer this unique opportunity for our worldwide customers to adopt impeccable antibody binding assay service.
Binding assays are commonly required by the regulatory departments, like FDA and EMA, to quantify antibody-target interactions and obtain functional profiles, especially for therapeutic antibodies. It represents one critical approach for not only affinity evaluation but also immunogenicity and cytotoxicity assessment. To develop and validate highly robust and sensitive binding assay strategies is of great importance during antibody drug discovery and development.
Fully understanding its significance, Creative Biolabs has combined extensive knowledge and experience in therapeutic antibody exploitation with multiple state-of-the-art techniques and established a novel binding assay platform. We provide diverse assay formats by employing various technical approaches, including but not limited to:
Taking advantage of these sophisticated methodologies, we have developed, optimized and validated a panel of binding assays, which can generally be sorted into two distinct types:
Non Cell-Based Ligand-Binding Assay
Ligand-binding assay, termly LBA, is an easy and robust method to evaluate the binding ability of an antibody to its specific target. A recombinant antigen or target will act as the ligand to capture antibodies with adequate affinity. The binding activities can be real-time monitored and analyzed, with simultaneous-generated kinetic data including PK, PD, TK, etc. Creative Biolabs is well-qualified for conducting LBA in GLP-compliant laboratories under strict regulatory guidelines, providing solid support for downstream research and submission.
As further complement of LBA, cell-based binding assays (CBA) acts as an indispensable part in determining the exact mechanism of action for your antibody. Regulatory agencies demand that cell-free LBA outcomes must be eventually translated into a cell-based format, so that antibody potency and bioactivity can be better assessed in a more physiologically relevant environment. The cell-based system can offer many advantages, such as preservation of the native target form, and higher sensitivity towards physiochemical changes (i.e. glycosylation patterns and conformational alternations). Creative Biolabs brings out a comprehensive portfolio of CBA, for characterizing antibody-target interactions in living whole cells, or cell lysates.
Antibody Cross-Reactivity Testing Service
Antibody cross-reactivity testing is performed to identify any unforeseen binding of therapeutic or diagnostic antibodies to human tissues that do not correspond to the target antigen. Cross-reactivity testing of therapeutic and diagnostic antibodies is a necessary step in clinical application. Creative Biolabs provides an antibody cross-reactivity testing service with diverse testing technologies for the benefit of customers worldwide, enabling a comprehensive pre-clinical assessment of therapeutic and diagnostic antibodies.
Taken together, our exhaustive service of antibody binding assays can guarantee our clients with most compelling and reproducible outcomes, offering absolute confidence for subsequent investigations. Additionally, experienced experts in Creative Biolabs are also specialized in designing and performing high-quality custom assays, with different formats, endpoints, parameters, to satisfy any specific requirement. We also provide alternative immunogenicity detection service and Fc binding profiling service using our elegant binding assay platform at most competitive price. For more detailed information, please feel free to contact us or directly sent us an inquiry.
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