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Analytical Services for pDNA
Reliable analytics to keep your program moving. Integrated plasmid DNA analytical testing that reduce complexity, shorten timelines and simplify project management.
Analytical services run alongside every stage, confirming identity, purity and quality across your plasmid DNA pipeline.
This service is available for:
Overview
Customized Analytical Services for Your Plasmid DNA
As a customer-focused CDMO, time and cost efficiency remain central to every pDNA program. Our analytical strategy is therefore tailored to the intended application, development stage and selected quality grade, ensuring that each project receives the appropriate level of testing and documentation without unnecessary activities.
Depending on program requirements, our analytical services can cover plasmid identity, concentration, purity, supercoiled content and other relevant isoforms, as well as process-related impurities such as residual host-cell DNA, RNA and proteins. Microbiological and safety testing, including bioburden, endotoxins or sterility where applicable, can also be incorporated into the testing plan. Only the methods, specifications, reports and quality documentation required to support the selected research-grade, high-quality or GMP material are generated, helping control costs while maintaining the scientific rigor, traceability and regulatory readiness expected at each stage.
What We Offer for the Analysis
of Your Plasmid DNA
Custom Test Panels
Define only the tests and documentation needed for your application. This tailored approach avoids unnecessary cost and complexity while ensuring you generate the data that truly adds value to your program.
Analytical Method Development
Development of tailored analytical methods to assess critical pDNA quality attributes, including identity, concentration, purity, topology and process-related impurities, according to the intended application and required quality level.
Analytical Method Adaptation
Adaptation of existing methods to the specific plasmid, sample matrix, equipment and performance requirements, optimizing parameters to ensure suitable sensitivity, accuracy, precision and reproducibility under routine laboratory conditions.
Analytical Method Validation
Validation of analytical methods according to applicable quality and regulatory requirements, demonstrating parameters such as specificity, accuracy, precision, linearity, range, robustness and limits of detection or quantification.
Technical Specifications
The Right Analytical Package for Every Plasmid DNA Quality Grade
Our analytical packages are tailored to your plasmid DNA and its intended use. The table below summarizes the testing typically performed for Research, High-Quality and GMP grades.
| Analytical test | Research Grade Plasmid | High Quality Grade Plasmid | GMP Grade Plasmid |
|---|---|---|---|
| Appearance | |||
| Appearance / visual inspection | ✓ | ✓ | ✓ |
| Quantity | |||
| DNA concentration by A260 | ✓ | ✓ | ✓ |
| DNA concentration by fluorescence assay, e.g. Qubit/PicoGreen | ○ | ✓ | ✓ |
| Purity ratios | |||
| A260/A280 ratio | ✓ | ✓ | ✓ |
| A260/A230 ratio | ✓ | ✓ | ✓ |
| Identity | |||
| Plasmid size confirmation by agarose gel | ✓ | ✓ | ✓ |
| Restriction enzyme digestion / restriction map | ✓ | ✓ | ✓ |
| Insert confirmation by PCR | ○ | ✓ | ✓ |
| Full plasmid sequencing, Sanger/NGS | ○ | ✓ | ✓ |
| Plasmid map verification / annotation review | ○ | ✓ | ✓ |
| Topology | |||
| Supercoiled plasmid DNA percentage | ○ | ✓ | ✓ |
| Open circular / linear / nicked isoforms | ○ | ✓ | ✓ |
| Purity | |||
| Residual impurities (i.e. host cell genomic DNA, RNA, proteins, antibiotics, residual solvents, detergents) | — | ✓ | ✓ |
| Residual RNA | ○ | ✓ | ✓ |
| Residual host cell protein / total protein | ○ | ✓ | ✓ |
| Safety | |||
| Endotoxin, LAL / recombinant method | ○ | ✓ | ✓ |
| Bioburden | — | ✓ | ✓ |
| Sterility | — | ○ | ✓ |
| Absence of bacteriophage contamination | — | ○ | ✓ |
| Mycoplasma | — | — | ✓ |
| Potency | |||
| In vitro expression / transfection assay | ○ | ○ | ✓ |
| Restriction/linearization efficiency, if used as mRNA template | ○ | ✓ | ✓ |
| Physicochemical | |||
| pH | ○ | ✓ | ✓ |
| Conductivity | ○ | ✓ | ✓ |
| Osmolality | — | ○ | ✓ |
| Stability | |||
| Short-term stability / shipping simulation | ○ | ✓ | ✓ |
| Freeze-thaw stability | ○ | ✓ | ✓ |
| Accelerated stability | — | ○ | ✓ |
| Long-term stability | — | ○ | ✓ |
| Retention of plasmid construct / selectable marker in production strain | — | ○ | ✓ |
Every project is unique. Our analytical packages are tailored to provide only the testing your pDNA cell bank and application require.
Why Choose 53Biologics for Plasmid DNA Manufacturing
Collaborative Analytical Planning
Work directly with the scientists responsible for your analytical program. Together, we define the critical quality attributes, specifications and testing strategy needed to support confident decisions at every project stage.
Confidence in
Every Result
Our team applies specialized expertise to assess pDNA identity, concentration, purity, topology and process-related impurities. We develop, adapt and validate analytical methods to generate reliable, scientifically meaningful data.
A Strategy Shaped
Around You
Robust analytical testing and clear documentation help ensure product quality and support confident release and development decisions.
Analytical Continuity as You Progress
Stay with one analytical partner from early characterization through method validation, release testing and stability studies. Maintaining analytical knowledge and method history with the same team supports consistency and smoother progression toward GMP.
Request a Quote for Your Plasmid DNA Analytical Project
Tell us about your plasmid DNA program and the quality grade you need — our team will get back to you as soon as possible.
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