Endotoxin Testing in Immunoglobulin

Immunoglobulin (Ig) refers to a globulin with antibody (Ab) activity or chemical structure similar to an antibody molecule. Immunoglobulin is a tetrapeptide chain structure composed of two identical light chains and two identical heavy chains connected by interchain disulfide bonds. There are five types of immunoglobulins, namely, immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM), immunoglobulin D (IgD), and immunoglobulin E (IgE). The immune system consists of immune tissues, organs, immune cells and immune-active molecules. Immunoglobulins are a class of immune-active molecules, and immune-active molecules include immune cell membrane molecules, such as antigen recognition receptors, differentiation antigens, major histocompatibility molecules, and some other receptor molecules; they also include immune cells and Molecules synthesized and secreted by non-immune cells, such as immunoglobulin molecules, complement molecules, and cytokines. Immunoglobulin is a chemical structural concept. The chemical basis of all antibodies is immunoglobulin, but not all immunoglobulins have antibody activity.

Method

Intravenous human immunoglobulin (IVIG) is an effective intravenous drug for the treatment of primary immunodeficiency, secondary immunodeficiency, and autoimmune diseases (Kawasaki disease, idiopathic thrombocytopenic purpura). Bacterial endotoxin test is an important aspect of drug quality inspection for intravenous preparations. Bacterial endotoxin test is a method to detect or quantify endotoxins produced by Gram-negative bacteria by using limulus reagents to determine whether the limit of bacterial endotoxin in the test product meets the requirements. Generally, bacterial endotoxin testing methods include gel method and photometric method, the latter includes turbidity method and color matrix method. The rabbit method for pyrogen testing is an important part of the quality evaluation of biological products, but the rabbit method is difficult to standardize, difficult to quantify, and has poor reproducibility and sensitivity. Kinetic turbidity method (kinetic turbidimetric method) is to determine the endotoxin content from the quantitative relationship between turbidity change and endotoxin concentration by measuring the turbidity change during the gel formation process. Advantages, the method has been used for the testing of vaccines and antibiotics for injection.

Kinetic turbidimetric analysis (KTA) can be performed on a microplate reader and accompanying software. In addition to the product to be tested, effective analytical methods should include endotoxin standards, positive product controls, and negative controls included in the analysis. All test values need to be determined from at least duplicate samples.

Product interference

Prior to the regular release of products using LAL testing, it is necessary to verify the presence of product interference by performing suppression/enhancement tests on each product type. By analyzing a sample of a product spiked with a known amount of endotoxin and detecting 50-200% of the spiked endotoxin, the product can be determined to be interference-free.

Prepare a standard curve covering the test range. Spike the product to levels that are equal to or near the middle of the standard curve. If the reported endotoxin level is 50% to 200% of the spiked endotoxin concentration, the product is determined to be interference-free. For example, if the standard curve varies between 0.1 and 10 EU/mL, endotoxin should be incorporated into the product to produce a concentration of 1 EU/mL. Acceptable endotoxin recovery is between 0.5 and 2.0 EU/mL.

Our Services for endotoxin testing in immunoglobulin

Creative BioMart offers a corresponding endotoxin testing service. You can purchase the corresponding endotoxin removal kit and related accessory products according to the needs of your own samples. We guarantee that all instruments, water, reagents, and consumables used in the experiment are free of endotoxins, and the experiment is conducted in a clean room to ensure that low levels of endotoxins are returned to the sample. In addition, we can also provide you with related services including:

Our solutions

Project name Endotoxin testing in human albumin
Testing purpose Intravenous human immunoglobulin (IVIG) can be used to treat primary immunodeficiency, secondary immunodeficiency and autoimmune diseases. Bacterial endotoxin testing is an important aspect of the quality inspection of intravenous preparations.
Testing cycle 3-5 days.
Service including We provide you with raw data and test reports.
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