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Plasmid Physical Property Analysis

The regulatory requirements for the physical characterization of GMP-grade plasmids are intended to ensure the quality, safety and efficacy of plasmids produced for human clinical use or commercial application. Adherence to these guidelines is necessary to obtain high quality plasmids, regulatory approval and to ensure that the plasmids can be used effectively for the intended application. Creative Biogene provides comprehensive testing to accurately characterize the physical properties of the plasmids we produce, ensuring that the plasmid products we provide meet and exceed the quality and safety requirements they are expected to meet.

Plasmid Physical Property Analysis

Content and Requirements of Physical Property Identification

  • Appearance

The appearance of GMP-grade plasmids should be clear, colorless, and free of visible particles or contaminants.

  • Concentration

The concentration of GMP grade plasmids should be accurately measured and controlled within a specific range. Concentration ranges may vary depending on the intended use of the plasmid and the regulatory requirements of the country of manufacture.

  • pH

The pH range for GMP grade plasmids is typically between 6.0 and 8.0. The pH of the final plasmid product must be controlled within this range to ensure that the plasmid maintains its structural integrity and biological activity.

  • Osmotic pressure

The osmotic pressure of the plasmid solution must also be controlled during the production process. Osmotic pressure measures the concentration of solutes in solution and typically ranges from 200 to 450 mOsm/L for GMP grade plasmids.

  • Dispersibility

GMP grade plasmids should be able to disperse easily and uniformly in sterile solutions without forming aggregates or particulate matter. The dispersed solution should remain clear with no visible turbidity or precipitation. Dispersibility should be maintained over the shelf life of the plasmid.

Physical Property Identification Methods at Creative Biogene

Testing ContentTesting Method
AppearanceVisual examination
ConcentrationUV spectrophotometer
pH valuepH meter
Osmotic pressureOsmometer
DispersionTurbidity and visual examination

Creative Biogene is committed to performing comprehensive quality control testing to characterize the physical properties of the plasmids prior to release. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.
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