Residual DNA Size Analysis Kit-Human cell Plus

Against the backdrop of rapid growth in the biotechnology and pharmaceutical industries, the demand for bioderived products such as monoclonal antibodies, vaccines, and gene therapies has increased significantly. These products, which are often produced using human cell lines, have revolutionized the treatment of a wide range of diseases. Despite their enormous potential, there is a pressing need to control and monitor the quality and safety of these biotherapeutic products. DNA naturally present in host cells can be inadvertently introduced into the final product during the manufacturing process. The presence of such residual DNA poses potential risks, including immunogenicity and carcinogenicity, which are important concerns for regulatory agencies such as the FDA and EMA. Therefore, strict guidelines and regulatory standards have been established requiring a thorough evaluation and quantification of residual DNA in biopharmaceutical products. The Residual DNA Size Analysis Kit - Human Cell Plus was developed to meet this critical need. It is an advanced and comprehensive solution for the detection and size determination of residual DNA in biologics derived from human cell lines. The kit utilizes state-of-the-art technologies and methods to not only quantify residual DNA but also determine the size distribution of DNA fragments.