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Circular double-stranded plasmid DNA (pDNA) plays a crucial role in vaccine development, cell and gene therapy, and recombinant protein or mAb production. These small pieces of DNA carry targeted genetic material that forms the basis for the therapeutics. Given their widespread use, pDNA quality control and analytics are critical in the biopharmaceutical industry to ensure safe, effective treatments.
pDNA typically exists in one of three isoforms: supercoiled, linear, or open circular, which is where pDNA analytics and quality control come into play. Purity and/or isoform composition requirements are application-dependent. For example, high purity of the supercoiled pDNA isoform is required in gene therapy manufacturing, whereas isoform composition is usually not defined for the preparation of in vitro-transcribed (IVT) mRNA production.
Overall in clinical applications, the primary considerations for pDNA are therapeutic effectiveness, safety, and quality according to Cordula Pertl, PhD, head of molecular biology at Revvity Gene Delivery (previously Sirion Biotech). “Regulatory expectations have increased, necessitating consistent standards and comprehensive documentation,” Perlt emphasized.
Producing pDNA for clinical trials requires high-quality raw materials and rigorous pDNA quality control measures. A scalable and reproducible production process is essential to ensure consistent quality and structural integrity across different batches due to potential impacts on effectiveness and safety. Cost efficiency, both in production and characterization, is another key factor.
Streamlined pDNA Quality Control and Analytics
The new LabChip™ Plasmid DNA assay from Revvity is designed to streamline pDNA quality control and analytic workflows in upstream and downstream processing workflows. The assay separates the three primary isoforms of pDNA in under 2 minutes/sample while providing precise purity assessment based on the corrected area percentages for each conformation.
“The Revvity LabChip GX/GXII Touch™ microfluidic electrophoresis systems can efficiently process large numbers of samples and analyze different isoforms of pDNA, such as supercoiled, linear, and open circular forms,” said Pertl. “This assay provides precise control over the experimental conditions, ensuring consistent pDNA quality and facilitating controlled, reproducible manufacturing processes that satisfy both clinical and commercial demands.”
A key advantage is cost efficiency, as the system requires minimal sample preparation and reduces the need for large volumes of reagents and samples. By automating many steps of the electrophoresis process, the LabChip systems reduce labor and reagent costs, making the process more economical.
The importance of timely and precise information for appropriate bioprocessing course correction cannot be overstated due to the influence on product quality and costs. The limit of detection (LOD) of the assay is ≥ 25 pg/μL.
Fully Automated and 21 CFR Part 11 Compliant
Not only is the LabChip Plasmid DNA assay fully automated but also, importantly, both the LabChip GX Touch nucleic acid analyzer and the LabChip GXII Touch microfluidic electrophoresis system are provided with software capable of 21 CFR Part 11 compliance. Compared to traditional methods such as slab gel electrophoresis, HPLC, or capillary electrophoresis, the platforms and assays offer faster run times, simplified instrument and chip preparation, accurate results, and minimized sample handling.
The LabChip Plasmid DNA assay is compatible with a wide variety of pDNA sizes from 2-13 kbp. For 384-well plates, only 20 µL of diluted sample is needed, 40 µL for 96-well plates. Despite these low sample volumes, the LabChip plasmid DNA assay covers a linear concentration range for pDNA analytic sample input from 50 – 500 pg/µL.
Designed to streamline pDNA workflows, the LabChip Plasmid DNA assay rapidly separates the three primary isoforms of pDNA while providing precise purity assessment. The fully automated platforms cost effectively simplify pDNA quality control and analytics to advance the development and commercialization of life-saving therapeutics.
For Research Use Only. Not for use in diagnostic procedures.
Learn more www.revvity.com/LabChip-pDNA
