登录 | 注册    关注公众号  
微信公众号
搜索
 >  Kits>DNA >OPA-R019

resDetect™ PG13 resDNA Quantitation Kit (qPCR)

For research use only.
此产品为在研产品。如果您对此产品有兴趣,请直接联系我们。我们会根据您的需求相应地加速我们的研发进程,并为您进行产品预留。

产品描述(Product Details)

PG13 resDNA Quantitation Kit is designed for quantitative detection of residual PG13 DNA in biopharmaceuticals. Based on real-time quantitative PCR (qPCR) method, this kit makes the detection of the residual DNA from Pichia pastoris rapid and reliable. The lower limit of quantitation is XX 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)

  1. High sensitivity for optimal product safety: LLOD (XXX fg/µL) for detection of residue host cell DNA
  2. High specificity: No cross-reactivity with unrelated DNA
  3. Validation: ICH Q2(R2) as validation of analytical procedures
  4. 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 PG13 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 quantitation kits are designed to ensure that the final product is safe for human use.

 

前沿进展

 
 
货号/价格
文档
联系电话:
+86 400-682-2521(全国)
010-53681107(北京)
021-50850665(上海)
运输方式
订单邮箱:
order.cn@acrobiosystems.com
技术支持邮箱:
tech.cn@acrobiosystems.com
前沿进展
点击查看详细
相关产品
View All DNA View All PCR

消息提示

请输入您的联系方式,再点击提交!

确定