Overview
Plasmid and DNA analysis challenges can be a thing of the past.
Whether you need high-quality supercoiled plasmid DNA (pDNA) for protein and viral vector production or linearized double-stranded DNA (dsDNA) for in vitro transcription (IVT), you and your team can rely on workflows that bring value to your double-stranded nucleic acid analyses.
Using restriction enzyme digestion paired with high separation power lets you determine the gene insert, regulatory regions, nuclease sites or encoded poly-A tails of your raw material pDNA with confidence.
Solutions that cover sequencing, microbial typing and gene expression analysis provide you with the needed flexibility to overcome future challenges.
Workflow
pDNA isoforms
Ensuring the correct isoform of plasmid DNA (pDNA) is crucial for the production of proteins, viral vectors and IVT RNA. Reliable and reproducible analysis and quantitation of topological variants of pDNA are key to determining the quality of intermediate products during development. An efficient transfer to quality control (QC) is desirable, however, and requires highly robust workflows.
Explore how to confirm linearized dsDNA size, quantity and purity simultaneously. Determine the purity of covalently-closed circular/supercoiled pDNA and monitor pDNA stability with high quality and robustness.
pDNA isoforms
Solution
Featured resources
Help ensure purity requirements are met for plasmid DNA with sensitive, accurate and reproducible workflows for the determination of supercoiled, open-circular and linear pDNA isoforms.
Look into how scientists at Pfizer are ensuring plasmid quality with a sensitive and robust workflow suitable for pDNA purity assessment and degradation monitoring.
Workflow
pDNA restriction fragment analysis
Information on gene inserts, regulatory regions, and nuclease sites of pDNA is important for investigational new drug (IND) submissions for viral vectors and protein therapeutics. Furthermore, poly-A tails for IVT mRNA are frequently encoded in the pDNA template and their lengths and potential heterogeneity requires assessment.
While these attributes can be analyzed with restriction fragment assays, accurate and reproducible sizing over an extended size range are challenges analytical scientists face.
pDNA restriction fragment analysis
Solution
Workflow
pDNA sequencing
Recombinant DNA technology has revolutionized drug product manufacturing. The verification of the coding information of the expression product through pDNA sequencing is an important step along the way. It mitigates the need for maintaining cell banks and reduces the risk of losing relevant information. High-quality data obtained in a routine manner is required for such analyses.
pDNA sequencing
Solution
Featured resources
Reduce the risk of losing relevant information and avoid the need to maintain cell banks using an established, compliant-ready DNA sequencing solution to verify the coding information of your expression products.
Workflow
Microbial identification and typing
Microbial contamination is a major risk to biopharmaceutical production that must be avoided. The introduction of sterile, single-use technology certainly helps to ensure products are free from unwanted microbial and viral contaminants that could affect safety and product quality. In addition to the final product, raw materials also need to be tested. High-quality DNA and complementary DNA (cDNA) sequencing using routine workflows can reliably assist with ensuring the necessary quality of raw materials and final products.
Microbial identification and typing
Solution
Featured resources
Read how DNA and cDNA sequencing can be used to monitor raw materials, cell lines and finished products for mycoplasma, other bacteria, fungi, viruses and virus-like particles to ensure their sterility.
Workflow
Gene expression analysis
The answer lies in the genes – but which genes are being expressed?
Gene expression analysis can advance biomarker discovery, vaccine development and other research and development efforts. Highly accurate and reproducible results using a low-cost solution with multiplexing capabilities can reduce bottlenecks and advance your research programs.
Take charge by bringing a multipurpose genetic analysis solution in-house.
Gene expression analysis
Solution
Featured resources
Discover how to monitor and compare the expression patterns of alternatively spliced genes in tissues and cell lines using simultaneous amplification of transcript variants.
All resources
Break through the barriers to developing better LNP-based drugs and make better use of your time with streamlined CE and MS workflows for mRNA-LNPs.
Explore the flexibility afforded by the GeXP Genetic Analysis system for quantitative gene expression, plasmid sequencing, genotyping, microbial identification and fragment analyses.
Help ensure purity requirements are met for plasmid DNA with sensitive, accurate and reproducible workflows for the determination of supercoiled, open-circular and linear pDNA isoforms.
Look into how scientists at Pfizer are ensuring plasmid quality with a sensitive and robust workflow suitable for pDNA purity assessment and degradation monitoring.
Hear from the CEO of PlasmidFactory GmbH about how CE solutions are used for characterization of supercoiled minicircle DNA for CAR-T and viral-vector manufacturing.
Investigate a high-resolution workflow for sensitive size determination of plasmid fragments. Obtain results over a wide range, from 100 bp to 15,000 bp, with great accuracy, repeatability and precision.
Reduce the risk of losing relevant information and avoid the need to maintain cell banks using an established, compliant-ready DNA sequencing solution to verify the coding information of your expression products.
Read how DNA and cDNA sequencing can be used to monitor raw materials, cell lines and finished products for mycoplasma, other bacteria, fungi, viruses and virus-like particles to ensure their sterility.