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.
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Take back your time by separating linear, supercoiled, and open circular dsDNA plasmid variants with baseline resolution within minutes
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Determine and monitor the purity and stability of supercoiled pDNA, reproducibly
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Ensure consistent quality for subsequent IVT with reproducible sizing up to 15,000 bp
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Efficiently transfer assays to quality control with highly reproducible, precise and robust solutions
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Streamline data management and compliance needs through compatiblity with the Empower Chromatography Data System (CDS)
pDNA isoforms
Solution
PA 800 Plus system
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.
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Achieve high-resolution, accurate and reproducible dsDNA analysis
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Accurately determine pDNA fragment sizes from 100 to 15,000 bp
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Assess encoded poly-A tail lengths for IVT mRNA production
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Simplify DNA analysis with a turnkey, kit-based solution
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Streamline data management and compliance needs through compatiblity with the Empower CDS
pDNA restriction fragment analysis
Solution
PA 800 Plus system
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.
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Obtain high-quality sequencing results using linear polyacrylamide gels and coated capillaries
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Limit background signal and achieve high signal-to-noise ratios with near-infrared dyes
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Enable routine sequencing analyses with reduced GC compression
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Accomplish accurate readthroughs of stop sequences using dGTP chemistry
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Confidently gather pDNA sequencing results using an established, compliant-ready solution
pDNA sequencing
Solution
GenomeLab GeXP system
DTCS Quick Start kit
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.
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Achieve high-quality sequencing results for DNA and cDNA using linear polyacrylamide gels and coated capillaries
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Obtain high signal-to-noise ratios by limiting background signals with near-infrared dyes
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Comfortably rely on routine sequencing analyses with reduced GC compression
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Enable accurate readthroughs of stop sequences using dGTP chemistry
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Confidently accomplish pDNA sequencing results using an established, compliant-ready solution
Microbial identification and typing
Solution
GenomeLab GeXP system
DTCS Quick Start kit
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.
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Understand minor differences in gene expression down to 0.5-fold changes
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Have confidence in your analyses regardless of sample amounts
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Obtain gene expression analysis results with superior linearity and precision
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Confidently gather gene expression results using an established, compliant-ready solution
Gene expression analysis
Solution
GenomeLab GeXP system
DTCS Quick Start kit
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.
Associated applications
Cell therapy
Take chimeric antigen receptor (CAR) T-cell therapy and other cell therapy programs to the next level with tailored analytical solutions that provide actionable answers. Evaluate lentiviral vectors and lipid nanoparticles for gene editing and understand proteome changes with a collaborative team of experts.
Messenger RNA analysis
Break through barriers and extend the frontiers of messenger RNA (mRNA), self-amplifying RNA (saRNA) and circular RNA (circRNA) development with intuitive analytical solutions. Confidently innovate with high-quality, sensitive and accurate data to assess integrity, purity and critical quality attributes (CQAs).
Protein therapeutics
Tackle the next frontier in protein therapeutics with analytical strategies ignited by collaboration.
Residual nucleic acid analysis
Optimize workflows to reliably detect and monitor process-related impurities. Ensure the safety of next-generation viral products with accurate, reproducible sizing of residual DNA and RNA and simultaneous quantitation.
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.