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In the quality control program of the GMP plasmid production process, purity determination is critical to ensure the safety and efficacy of the final product. The purity of plasmid DNA is determined by assessing the level of impurities present in the final product, which may include proteins, RNA and other cellular components that have the potential to affect the efficacy and safety of the DNA product. Creative Biogene offers a variety of methods to characterize the purity of plasmids, ensuring the delivery of high-quality plasmid products to our clients.
| Test Item | Method |
| OD260/280 | Spectrophotometer |
| Plasmid superhelical ratio | Micro BCA, SDS-PAGE electrophoresis |
| Protein residues | qPCR, agarose gel electrophoresis |
| Host DNA | qPCR, agarose gel electrophoresis |
| Host RNA | Agarose gel electrophoresis, RT-PCR assay, fluorescence quantification |
| Antibiotic residues | Immunoassay |
Purity is estimated by measuring the absorption of DNA by UV light and based on the ratio of the absorption at 260 nm to that at 280 nm. a ratio of 1.8 or higher indicates high purity DNA.
Separates DNA molecules based on size and allows detection of possible impurities in the preparation.
As plasmid DNA is produced in different stages, impurities may enter. High performance liquid chromatography determines the purity of plasmid DNA samples by separating them into their respective components. By using HPLC, Creative Biogene is able to detect and purify these impurities before moving on to the next stage of production.
SDS-PAGE electrophoresis can be used to determine the purity of plasmid DNA by separating it from other cellular components. Creative Biogene performs this by loading plasmid DNA onto a polyacrylamide gel along with a labeled protein of known molecular weight, and then placing the gel in an electric field that separates the proteins based on their size. Since plasmids are smaller than most proteins, they usually show up as a band on the gel, indicating high purity.
Immunoassays are a valuable tool for detecting antibiotic residues with high sensitivity and specificity in GMP plasmid production. Creative Biogene offers immunoassays that use the interaction between antibodies and antigens to detect and quantify the presence of specific molecules or compounds in a sample. The advantage of this method is the ability to detect low concentrations of antibiotic residues, which can ensure the safety and purity of plasmids for gene therapy.
Creative Biogene offers RT-PCR technology with high sensitivity and specificity, ideal for quality control during GMP plasmid production. By detecting the presence of target genes in the plasmid product, it ensures that the final product meets regulatory standards and is suitable for its intended use.
Creative Biogene's quality control team is committed to providing high quality services in plasmid purity determination and product release to ensure the production of safe and effective plasmid products for our clients. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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