GMP grade plasmid DNA by NXBio
NXBio is dedicated to providing high-quality GMP grade plasmid DNA for clinical and commercial applications. Our GMP grade plasmid is manufactured according to full Good Manufacturing Practice (GMP) standards in qualified clean rooms, ensuring the highest level of quality and safety for use in applications such as DNA vaccines, direct-delivered gene therapy, and late-phase viral vector products.
Learn more about plasmid DNA by NXBio
What is plasmid DNA?
Plasmid DNA refers to small, circular, double-stranded DNA molecules found in bacterial cells. Plasmids carry antibiotic resistance genes or other functional genes and are widely used in molecular biology applications, such as gene therapy and cell therapy.
How does NXBio ensure plasmid DNA purification and plasmid DNA isolation?
NXBio uses the alkaline lysis method for the isolation of plasmid DNA from bacterial cells, followed by purification steps, including anion-exchange chromatography and ethanol precipitation. These methods ensure high-quality plasmid DNA with minimal contamination.
What are the applications of plasmid DNA?
Plasmid DNA has a wide range of applications, including gene therapy, cell therapy, DNA sequencing, molecular biology research, and clinical applications such as DNA vaccines and mRNA manufacturing.
How do I know the plasmid yield and quality?
NXBio performs comprehensive analysis, including UV analysis, AGE analysis, and restriction enzyme digestion, to determine the concentration and purity of plasmid DNA. We provide a Certificate of Analysis (CoA) that includes details about the plasmid yield, concentration, and quality.
What bacterial strains does NXBio use for plasmid DNA production?
NXBio commonly uses E. coli strains, such as E. coli DH5α, for plasmid DNA production. These strains are known for their high plasmid yields and compatibility with a wide range of resistance plasmids.
Does NXBio provide endotoxin-free plasmid DNA?
Yes, NXBio offers endotoxin-free plasmid DNA for sensitive applications, such as gene therapy and clinical applications. Our purification of plasmid DNA methods, including tangential flow filtration and chromatography steps, help to achieve endotoxin-free plasmid DNA.
Can NXBio support different plasmid DNA scales and grades?
Yes, NXBio offers a variety of plasmid DNA services, including Research Grade, High Quality Grade, and GMP Grade plasmid DNA, to accommodate different scales and applications, from pre-clinical research to clinical and commercial use.
How does NXBio ensure the quality and consistency of plasmid DNA?
NXBio utilizes single-use or reused process equipment, segregated laboratories, and fully traceable non-animal origin raw materials to maintain the quality and consistency of our plasmid DNA products. Our manufacturing processes are aligned with regulatory standards, and our plasmid DNA is provided with a Certificate of Testing.