膜杰作
Star Staining
产品描述（Product Details）
Human resDNA Quantitation Kit is designed for quantitative detection of residual Human DNA in biopharmaceuticals (Antibodies, cells, viruses, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA form Human cells rapid and reliable. The lower limit of quantitation is XXX fg/µL.All procedures are typically in less than 4 hours.
Use the kit after you extract host cell DNA from test samples.
产品特性（Features）
- High sensitivity for optimal product safety: LLOD (XXX fg/µL) for detection of residue host cell DNA
- High specificity: No cross-reactivity with unrelated DNA
- Validation: ICH Q2(R2) as validation of analytical procedures
- High-quality: This kit is manufactured in GMP facility and alignment with the ISO 13485 standard.
应用说明（Application）
The kit is used for quantitative detection of residual Human DNA in biopharmaceuticals.
For use in quality control/manufacturing process only.
It is for research use only.
背景（Background）
Residual host cell DNA refers to fragments of DNA from the host organism that are left behind after a biological process such as the production of a biopharmaceutical product or the cultivation of a cell line. This residual DNA can potentially contaminate the final product and affect its safety and efficacy. In the context of biopharmaceutical production, regulatory agencies such as the FDA and EMA have set limits on the amount of residual host cell DNA that is acceptable in a final product. These limits vary depending on the type of product and the route of administration, and residue host cell DNA quantitative kits are designed to ensure that the final product is safe for human use.
