Residual nucleic acid analysis

Optimize your workflows to reliably detect and monitor process-related impurities resulting from manufacturing of plasmids, cell-culture derived therapeutics and vaccines. Ensure the safety of your next-generation viral products with accurate and reproducible sizing of residual DNA and RNA and simultaneous quantitation.

Overview

Residual nucleic acids require thorough assessment due to potential safety risks. Discover intuitive workflows for analyzing host cell DNA and RNA that provide meaningful answers based on high-quality results, and execute your product development and quality control processes with confidence. 

Be empowered to tackle the analytical challenges of plasmids, vaccines and therapeutic proteins derived from bacterial, insect or mammalian cells.

Residual DNA analysis

Workflow

Host cell DNA poses a potential safety risk for cell culture-derived vaccines and therapeutic products. Reliable size determination and simultaneous quantitation of residual DNA are crucial to enable risk assessment and ensure product safety.

Be empowered to address safety concerns linked to residual DNA with high-quality solutions based on capillary gel electrophoresis. Understand your product changes and be confident in determining risks more easily and reproducibly.

  • Determine risk based on the quantity and size of impurities
  • Customize size ranges to your product needs
  • Benefit from an intuitive and highly sensitive solution
  • Increase confidence in DNA assessments with excellent quantitative performance
  • Cover compliance needs through compatibility with the Empower Chromatography Data System (CDS)

Solution

Residual DNA analysis

PA 800 Plus system

Characterize therapeutic molecules with confidence with the kit-based system.

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dsDNA 1000 kit

Analysis of double-stranded linearized fragments and plasmid isoforms.

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Residual RNA analysis

Workflow

Residual host cell RNA can affect product quality and pose risks, such as eliciting undesired immune responses.

Take control of process-related nucleic acid impurities with accurate, reliable and high-quality data. Assess size distribution over a wide range and determine associated quantities with confidence. Be empowered to make informed decisions for risk assessments with turnkey solutions that meet your needs.

  • Determine risk based on the quantity and size of impurities
  • Avoid the sequence bias associated with methods based on polymerase chain reaction (PCR)
  • Benefit from an intuitive and highly sensitive solution
  • Increase confidence in impurity assessments with excellent quantitative performance
  • Cover compliance needs through compatibility with the Empower CDS

Residual RNA analysis

BioPhase 8800 system

Purpose-built for the biopharmaceutical scientist for efficiency and quality, enabling multiple samples to be run in parallel.

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RNA 9000 Purity & Integrity kit

Purity and integrity analysis of RNA therapeutics, vaccines and single stranded oligos.

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BioPhase BFS capillary cartridge

Pre-assembled bare-fused silica 8-capillary cartridge for the BioPhase 8800 system.

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Residual RNA analysis

PA 800 Plus system

Characterize therapeutic molecules with confidence with the kit-based system.

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RNA 9000 Purity & Integrity kit

Purity and integrity analysis of RNA therapeutics, vaccines and single stranded oligos.

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BFS capillary cartridge for the PA 800 Plus system

Pre-assembled bare-fused silica capillary cartridge for the PA 800 Plus system.

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Associated applications

Viral vector characterization

Optimize your processes with solutions that overcome the analytical challenges of viral vector-based drugs. Take control of full and empty ratios and protein and genome profiles. Break down the boundaries of protein and post-translational modification (PTM) characterization with dedicated high-resolution workflows offering unprecedented depth.

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Plasmid and DNA analysis

Advance your projects with purpose-built solutions for the analysis of plasmid DNA (pDNA) and double-stranded DNA (dsDNA) to support the development of your messenger RNA (mRNA), viral vectors, recombinant proteins and other new modalities.

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