Plasmid Residual DNA Quantitation kit
$1,899.00
质粒DNA(pDNA)是一种重要的遗传工具,广泛应用于生物制药生产中,用于将特定基因导入宿主细胞,以生产重组蛋白、疫苗、病毒载体以及基因和细胞治疗产品。在病毒载体生产中,通常使用多个质粒进行瞬时转染,以提供高效载体生产所需的遗传元件。残留质粒DNA是一种工艺相关的杂质,必须有效去除并进行监测,以确保生物制药产品的质量和安全。
| Catalog number: | D24011201 |
|---|---|
| Qty: | 100 Reactions |
| Include | Assay Kit only |
Description
高精度质粒残留DNA定量试剂盒
快速取得成果和简化的工作流程
1. 告别复杂的样品制备和漫长的等待时间。我们的试剂盒只需3个简单的步骤即可完成样品制备(仅需20分钟即可完成)。

2.样品制备试剂盒的所有组件均可在室温下储存——无需昂贵的冷藏,简化了库存管理。
| 样品制备试剂盒 | 内容 | 数量 | 贮存 |
| 结合液 | 60毫升 | 15℃-25℃(室温) | |
| 洗涤液 | 100毫升 | ||
| 洗脱缓冲液 | 10毫升 | ||
| 蛋白酶K | 2×1.5毫升 | 2℃-25℃(室温) | |
| 磁珠 | 1毫升 | ||
| 用户指南 | 1 | / |
3.qPCR MIX 仅需一种试剂,整个测试(从样品制备到结果)仅需 1.5 小时——显著提高您的 QC 工作流程效率。
|
resDNASEQ 质粒 残留DNA 定量试剂盒 |
内容 | 数量 | 贮存 |
| 质粒DNA qPCR混合物 | 2×1.0 毫升 | 首次使用前请避光保存于-15℃至-25℃;
首次使用后,在 2−8℃ 下保存 1 周。 |
|
| PCR阴性对照 | 1×1.0 毫升 | -15℃至-25℃ | |
| 质粒内部阳性对照 | 1.0 毫升 | ||
| 质粒 DNA 对照,1.5E+8 ng/μL | 40μL | ||
| 稀释缓冲液 |
7毫升 |
灵敏度和准确度
The kit provides a broad linear dynamic range of 1.5 copies/μL to 1.5 × 10⁶ copies/μL, covering the range of residual DNA concentrations typically encountered in bioproduction. With a standard-curve R² ≥ 0.999 and amplification efficiencies of 100.128% and 99.567%, the assay demonstrates excellent linearity, robust amplification performance, and high reproducibility, delivering consistent and reliable results across testing batches to support critical quality control decisions.
Leveraging proven TaqMan™ qPCR technology, this kit achieves a Limit of Quantification (LoQ) of 0.75 copies/μL of Linearized Plasmid and Limit of Quantification (LoQ) of 7.5 copies/μL of Circular Plasmid—enabling femtogram-level Plasmid DNA detection that outperforms industry standards.
Spiked sample tests confirm a recovery rate between 70% and 130%—ensuring accurate quantification even in complex matrices.
Why Choose Our Plasmid Residual DNA Kit?
Applications
- Biopharmaceutical production (monoclonal antibodies, recombinant proteins, fusion proteins)
- Viral and subunit vaccine manufacturing
- Plasmid-derived production cell line quality control
- Plasmid DNA residual quantitation in bioprocesses
- Regulatory compliance testing (aligns with WHO, FDA, and EMA guidelines)
- Bioprocess development and scale-up QC
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Frequently Asked Questions (FAQs)
1.What is the detection limit of the resDNASEQ Plasmid Residual DNA Quantitation Kit?
Answer: The kit offers an ultra-high sensitivity with a Limit of Quantification (LoQ) of 0.75 copies/μL—making it capable of femtogram-level Plasmid DNA detection, which exceeds global regulatory requirements.
2.How long does it take to complete a full Plasmid residual DNA test with this kit?
答:整个过程仅需1.5小时。样品制备仅需20分钟(3个简单步骤),qPCR扩增和定量步骤无缝衔接——与传统试剂盒相比,节省了宝贵的时间。
3.该试剂盒是否适用于疫苗生产过程中残留DNA的检测?
答:是的,它广泛应用于疫苗生产的质量控制流程,包括病毒疫苗和亚单位疫苗。它能有效定量疫苗底物和最终产品中的质粒残留DNA,从而支持符合世界卫生组织和区域监管标准。
4.样品制备组件是否需要冷藏?
答:不——样品制备试剂盒的所有组件都可以在室温下储存,这简化了储存和运输,降低了冷链成本,并确保在标准实验室条件下的稳定性。
5.该试剂盒是否符合世界卫生组织关于残留质粒DNA的指导原则?
答:当然。该试剂盒是专门为满足世界卫生组织规定的灵敏度要求(每治疗剂量10纳克质粒DNA)而开发的,因此是生物制药和疫苗生产中符合监管要求的可靠选择。
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