Creative Biolabs is offering the most comprehensive services for antibody development projects. With strict regulation and effective execution, we are dedicated to providing the most valuable solutions to complete your projects.
HighlightsWith over a decade of experience in phage display technology, Creative Biolabs can provide a series of antibody or peptide libraries that are available for licensing or direct screening. These ready-to-use libraries are invaluable resources for isolating target-specific binders for various research, diagnostic or therapeutic applications. Highlights
Creative Biolabs has established a broad range of platforms for developing novel antibodies or equivalents. These cutting-edge technologies enable our scientists to meet your demands from different aspects and tailor the most appropriate solution that contributes to the success of your projects.
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HighlightsImmunogenicity refers to the nature of drugs that stimulate the body to form specific antibodies or sensitized lymphocytes. In the development of biotechnological drugs, immunogenicity testing is an important task. Immunogenicity can affect the safety and efficacy of drugs, and even life-threatening risks due to the intersection of drug-resistant antibodies and endogenous proteins. Properly designing and validating a method for detecting anti-drug antibodies (ADA) and accurately interpreting the results of sample analysis is an indispensable part of the development of biosimilar drugs. Creative Biolabs can offer experienced guidance about ADA assay method development & validation and provide theoretical basis and technical support for clinical drug delivery and reduction of a drug-induced immune response.
Protein drugs often trigger an inevitable immune response in the body of the patient, producing ADA. Current methods for immunogenicity detection and screening are based on a variety of immunoassays to confirm the type of ADA. In other words, the reaction mechanism of the drug in vivo is observed by detecting the neutralizing antibody on the positive sample of ADA. The commonly used assay to detect immunogenicity is a bridging immunoassay. In this assay, the drugs can be labeled separately, with different labels, and any drug-resistant antibodies present in the sample will form a bridge between the two labeled molecules. The biggest advantage of this method is the ability to simultaneously detect multiple types of markers, such as IgG, IgM, and IgA. This method is also applicable to multiple species because all immunoglobulins are capable of forming immune complexes with two labeled drugs.
Fig.1 Acid dissociation to detect ADA and drug. (Kelley, 2013)
In recent studies, ADA assays have been widely used in developing recombinant human thrombopoietin mimetic peptide-Fc fusion protein (TMP-Fc). It is a candidate drug for the treatment of chronic idiopathic thrombocytopenic purpura. In general, TMP-Fc is injected into the body as a recombinant protein, which usually triggers the body to produce the drug itself and even an antibody to an endogenous protein. Scientists have established and validated immunogenicity assays based on surface plasmon resonance (SPR) technology for the immunogenicity of two TMP-Fc proteins in cynomolgus monkeys in a comparative study. The results showed that the two methods (anti-L, anti-R) were highly consistent with the positive samples of R samples and their detection time points. Therefore, the instant messaging (IM) analysis method based on the SPR system has met the requirements of biological product research and has successfully applied to the ADA detection of two TMP-Fc biological samples.
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