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Bioprocess lmpurity ELISA Kits

Bluegene Biotech/Cellgene Bioscience offers several new ELISA Kits for pharmaceutical enterprises to detect drug residues in different kinds of samples. There are several ways to detect drug residues, such as  LC-MS, FIA, TRFIA, and ELISA. Especially ELISA has high sensitivity, high specificity with simple procedures, and lower cost. Our ELISA kits for the drug residue test are all applied to the double antibody sandwich Enzyme-Linked Immunosorbent Assay.

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Drug Residue Test Kits Types

Reliable Quality, End-to-End Control

• With 20 years of deep technical expertise, we possess a professional and efficient R&D team with extensive problem-solving experience.


• Equipped with professional 2D-AAE and LC-MS combined coverage validation analysis software, capable of providing coverage detection for antibody raw materials from different batches.


• Establish a complete electronic archiving system for research and development data. All data are electronically retained in accordance with standards, and the complete set of data required for customer audits can be provided at any time. Ensure that the data results are true and reliable, with full traceability throughout the process, and fully meet the requirements of audit compliance.


• Supported by sufficient strategic reserves of key raw materials to eliminate batch-change risks at source, our highly streamlined production system has demonstrated extreme stability across numerous historical batches, providing robust assurance for quality and efficiency.


• From R&D to production, we maintain complete autonomy over the entire process—including core technologies, the manufacturing system, and quality control. This integrated self-sufficiency guarantees reliable supply stability.


• Establish an ISO13485:2016 medical device quality management system, covering the entire lifecycle management of product development, production, delivery, and after-sales.


Introduction of lmmunoglobulin

Immunoglobulin is a group of globulins with a special chemical structure and immune function that exists in the body fluids and on the surface of lymphocytes, it is a material base for antibodies. The five major classes of immunoglobulin defined by their different structures and functions are IgG, IgM, IgA, IgD and IgE. Their molecular size, charge, amino acid composition and carbohydrate content are very uneven. Immunoglobulin molecule carries out dual tasks—binding to antigens and stimulating antibody production.

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