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Accelerating ScienceLife in the Lab / Bioprocessing / Unlocking Efficiency: Utilizing Residual DNA Testing

Unlocking Efficiency: Utilizing Residual DNA Testing

Written by Life in the Lab Staff | Published: 10.19.2023

Residual DNA testing: Homebrew versus commercial off-the-shelf solution.

The benefits of commercial testing kits

Choosing the right tools for assessing safety and quality, such as residual DNA, in therapeutic products to enable compliance with regulatory guidelines is critical for manufacturers. Using commercially available kits is a wise choice as they help leverage standardized and tested components to ensure data accuracy and can help with regulatory compliance.

As biologic therapeutic development advances and becomes more complex, it is crucial to ensure product safety, quality, and compliance with regulatory agencies without increasing workflow time. Residual DNA, a byproduct of the cell-based production process, poses a significant potential risk if present in large amounts in the final product. Therefore, robust, accurate quantitation methods are essential for identifying and quantifying residual DNA. One highly effective solution adopted by biopharma companies of all sizes worldwide involves using commercially available residual DNA quantitation kits that test for-host cell DNA and plasmid DNA. Here are some considerations for integrating a commercially available for quantitating residual DNA into your bioprocessing workflow:

  • Time and cost efficiency: Developing an in-house assay requires significant internal resources, such as time, money, and in-house capabilities. It further entails identifying and validating component sources, as well as potentially multiple suppliers. On the other hand, commercially-available kits can provide tested, standardized, and optimized components, saving both time and money and mitigating potential risks during biologic manufacturing. These kits eliminate the need for time-consuming and resource-intensive in-house method development and are validatable. The Applied Biosystems™ resDNASEQ Residual DNA Quantitation Kits have been developed to help enable residual DNA testing to meet or exceed the most rigorous regulatory guidelines. The streamlined workflow typically includes instrumentation and analytical software, significantly reducing assay development and optimization.
  • Quality control: Commercially available kits, from established suppliers, adhere to standardization processes that have been rigorously validated for accuracy and consistency. Furthermore, they have been optimized to deliver exceptional sensitivity and specificity. These quality control processes help minimize the risks of contamination, variability, and other factors that can negatively impact results. This is especially crucial when transitioning beyond preclinical drug development into method development strategies.
  • Expert technical support: Commercially available kits enable the user to gain access to the developer’s expertise. This support often includes instrument installation assistance, user training, assay setup, troubleshooting, and even some data interpretation. Technical support is invaluable for researchers new to a particular assay or technique.
  • Access to new technologies: Kit manufacturers are often pioneers in developing new technologies and techniques. Therefore, using kits can provide access to innovative tools beyond one component, such as the solutions offered by Thermo Fisher Scientific leveraging qPCR for residual plasmid DNA quantitation or dPCR technologies for E1A fragment lengths within residual HEK host cell DNA. These kits enable reliable and accurate results by leveraging highly specific primers and probes.
  • Scalability: The overall workflow of the resDNASEQ Residual DNA Quantitation kit is scalable, accommodating experiments of varying sizes and easily adapting to changing needs, including specific manufacturing processes and product types. This scalability can be especially helpful to facilitate data accuracy for in-process or lot-release samples.

Arguably the most compelling reason to opt for a commercially available kit over an in-house developed assay (so called “homebrewed assay”) is convenience. Manufactured kits are designed to provide the necessary components to complete a project in a simple and easy-to-follow format. Overall, commercially available kits for residual DNA testing offer numerous advantages, including enhanced sensitivity, time and cost efficiency, improved product consistency, regulatory compliance, and access to expert technical support. Leveraging these kits can help streamline biologic manufacturing workflow processes, help implement strong quality control, and enable the safety and efficacy of the final product.

At Thermo Fisher Scientific, our commitment lies in supplying the global scientific community with the most advanced products and services that supports regulatory compliance. Thermo Fisher Scientific offers the Applied Biosystems resDNASEQ residual DNA quantitation portfolio, which provides comprehensive kits with standards and reagents, optimized sample preparation, ultrahigh sensitivity, and same-day actionable results.

To learn more about the resDNASEQ system, visit thermofisher.com/resdnaseq.

Recommended resources:

  • Application Note: Residual plasmid quantification in gene therapy manufacturing workflows using the QuantStudio Absolute Q Digital PCR System
  • Article: Addressing regulatory guidance for HEK293-cell and AAV-based therapeutics manufacturing
  • Flyer: resDNASEQ Host Cell Residual DNA Quantitation System
  • Infographic: Residual DNA testing: homebrew vs. off-the-shelf solutions
  • Poster: Streamlined High Performance Extraction and Quantitation of Host Cell Residual DNA in Bioproduction
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