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As a pioneer in biosafety testing, Creative Biogene provides a comprehensive residual material detection service for foods, drugs, pre-clinical and clinical products. This service aims to assist customers in detecting various residual materials produced in the manufacturing process, including but not limited to BSA, Benzonase, antibiotics, solvents, chemicals and other enzymes. Based on our excellent platform and experienced staff, you can expect to get reliable and convincing results soon.
1. Residual enzyme testing
Enzymes, like trypsin and liberase, currently are widely used in food and drug production. Since enzymes are usually derived from animal tissue, plant material and microorganisms, it is necessary to remove enzymes after the enzymatic reaction step to keep the purity of products. In the manufacturing process, a removal step is designed for this purpose. To ensure the safety of final products, it is required to quantify the residual enzyme before final product release. Creative Biogene employs an ELISA-based assay for residual enzyme detection. It is easy and quick to quantify the residual enzyme in a highly sensitive way.
2. Residual BSA testing
BSA is a common additive in serum-free culture system. Some of biological products and biopharmaceuticals are derived from cultured cells, which usually cultured with serum-free culture system for large-scale production. Therefore, BSA would be one of mainly contaminants for these products. An efficient and accurate detection assay is required for the quality control of these products. Creative Biogene employs an ELISA-based assay for residual BSA testing. It is a highly specific and sensitive assay.
3. Residual antibiotics testing
Antibiotics sometimes are used as additives in the manufacturing process of biological products. In order to decrease the effect of antibiotics, a clearance step followed by a validation step is designed in the whole process. The residual antibiotics should be tested before final products release. Creative Biogene employs an ELISA-based assay for residual antibiotics testing, especially for ampicillin and kanamycin. This approach is highly specific and sensitive.
Creative Biogene employs various assays for residual material detection, including but not limited to ELISA, GC, GC-MS, HPLC, LC-MS. With experienced scientist team and leading-edge platform, we have successfully established SOPs for detecting different residual materials.