Plasmid Residual DNA Quantitation kit

$1,899.00

Note: Price not include shipment & duty, contact us to get full quote.

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

resDNASEQ 质粒残留 DNA 定量试剂盒基于先进的 qPCR 技术,具有高分析性能、优异的重复性和简化的检测流程,并辅以全面的技术支持和售后服务。此外,我们的试剂盒还添加了内部阳性对照(简称 IPC)、UDG 酶等。更重要的是,结合我们的自动化核酸提取纯化系统,该试剂盒可实现高效、标准化的宿主细胞残留 DNA 检测自动化流程。

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?

As a professional manufacturer with deep expertise in Residual DNA testing kits, we’ve designed this kit to address the core needs of biopharmaceutical and vaccine facilities: superior quality, competitive pricing, simple operation, high precision, and rapid results. Unlike generic kits, our resDNASEQ Plasmid Residual DNA Quantitation Kit is tailored specifically for Plasmid-derived residuals, ensuring unmatched specificity and avoiding cross-reactivity with non-target DNA. The easy-to-use format reduces training time for lab technicians, while the room-temperature storage of sample prep components lowers logistical costs. Whether you’re a large biopharmaceutical company or a specialized vaccine manufacturer, this easy-to-use Plasmid residual DNA qPCR kit provides the performance and reliability you need to maintain rigorous quality standards.

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。

如需了解更多关于定价、定制或技术支持的信息,请立即联系我们的团队。我们致力于为您提供高质量的残留DNA检测解决方案,从而提高您生物生产流程的效率和信心。

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