ELISA is a powerful immunoassay that can qualitatively or quantitatively detect the chemicals, drug residual and other microbial toxins.
Creative diagnostics provides a variety of ELISA kits for the quantitative detection of chemical materials, therapeutic drugs and many other chemical and biological toxins.
Immunogenicity is an immune response by an organism against a therapeutic antigen. For example, protein therapeutics has been known to provoke adverse immune responses. The anti-drug antibodies may neutralize the drug activity, affect drug clearance, interfere with the drug pharmacokinetics, thus the efficacy and toxicity of drugs directly observed in non-clinical studies is usually inaccurate. Besides, the production of anti-drug antibodies may induce unwanted side effects, such as allergic reactions, anaphylactic shock, or autoimmunity in patients.
Because of the severity of these unwanted side effects, mandatory provision has been made by U.S. Food and Drug Administration (FDA) that immunogenicity studies should be a part of biological development programs, as well as immunogenicity assays must be custom developed and optimized for each therapeutic. Therefore, studies on immunogenicity assay have become necessary in the development of bio-therapeutic drug.
Creative Diagnostics have successfully developed a series of immunogenicity ELISA kits. With superior sensitivity, promising drug tolerance and ability to detect after acid dissociation of drug antibodies conjugates, our immunogenicity ELISA kits combine a fast, user-friendly format with a sensitive and specific assay.
Pharmacokinetics is physiologically and pharmacologically based science, describing “what the body does to the drug”. Typically, the pharmacokinetics of a drug should always be related to the pharmacodynamics, which provide drug concentration data over time and presents drug efficacy in three basic processes: adsorption, distribution and elimination. By testing non-clinical pharmacokinetic properties, the overall risk of failure in therapeutic development can be determined and the side effect thresholds can be established.
As the essential and basic part of drug safety program for each drug and drug candidate, pharmacokinetics assay allow the drug developer to comprehend efficacy and safety, which are required for new drug regulatory approval. Besides, pharmacokinetics have impact on almost all stages of the drug discovery and development process within the pharmaceutical industry and biotechnology laboratory, as well as regulatory authorities such as the U.S. Food and Drug Administration (FDA). Therefore, studies on pharmacokinetics assay have become very important in the drug development process.
Creative Diagnostics have successfully developed ready-to-use pharmacokinetics ELISA kits. With ability to test samples in serum and plasma, our fast and easy pharmacokinetics ELISA kits exhibit promising properties as useful tools for in vitro pharmacokinetics testing in drug development processes.