Built for In Vivo Performance and Safety

GenScript provides Tier 3 high-quality plasmid DNA optimized for in vivo applications. Produced by high-density fermentation, these plasmids undergo stringent quality controls, including ≥90% supercoiling, endotoxin levels ≤0.005 EU/µg, and quantitative analysis of host cell DNA and protein impurities. Guarantee yields from 5 mg to gram scale, with optional QC enhancements available to support research and translational studies.

≥ 90% DNA Supercoil Endotoxin ≤ 0.005 EU/μg Total Protein ≤ 1% Host gDNA ≤ 5% (qPCR) Scalable Yield (5 mg–grams) 72 hrs. Bioburden Test

Key Features & Benefits

Integrated Production Process icon

Verified DNA Structure
& Purity

  • ≥90% Supercoiled DNA
  • Endotoxin free: ≤0.005 EU/µg
  • Ultra-low host impurities: ≤5% genomic DNA, ≤1% total protein

Enhanced Safety & Regulatory Options

  • GLP-like production
  • Animal-origin–free production
  • Antibiotics-free production
  • TSE/BSE certification

Tier 3 Plasmid DNA Preparation Workflow

High-density fermentation

Alkaline lysis (P1/P2/P3)

Filtration, Centrifugation, Ultrafiltration

AKTA capture & Gel Filtration

Precipitation & Final Formulation

Core Specifications & QC Standards

QC Tests Specification
Default QC Items Quantity (Guarantee yield) ≥5 mg
Homogeneity ≥ 90% supercoil
Endotoxin Level ≤ 0.005 EU/µg
Appearance Clear, colorless, and free from precipitates or foreign particles
A260/230; A260/280 A260/230 ≥2 ; A260/280: 1.8-2.0 
Sequence Accuracy 100% alignment to reference (insert sequence)
Restriction Analysis DNA bands with expected sizes detected by agarose gel electrophoresis
Residual RNA Not visible on agarose gel
E. coli Genomic DNA ≤ 5% by qPCR
Total Protein ≤ 1% by NanoOrange Assay
Bio-Burden Test No viable microorganisms in/on culture media after 72hrs
Add-On QC Items pH 8.0±0.5
Mycoplasma Detection Negative
Ampicillin/ Kanamycin Detection Negative
Phage Detection Negative
Advanced 3-Step Purification AC + IEX + Gel Filtration
Sterile Filtration (Guarantee yield) 0.22uM
Animal-free Production Animal-free & TSE/BSE statement
GLP-like Production Full documentation/study report with trained personnel and verified instruments
Poly(A) Guarantee Polyadenylation purity and length guaranteed
AAV ITR Guarantee ITR sequence integrity guaranteed
Whole Plasmid Sequencing Sanger/NGS/Nanopore sequencing 

Custom Add-Ons, Take Your Plasmid Further

Whole Plasmid Verification (NGS & Nanopore)

Gain full-length sequence confidence with deep coverage across your entire construct

Enhanced Three-Step Purification

Gel Filtration, Affinity Chromatography, and Anion Exchange Chromatography for ultra-clean DNA with minimized host gDNA and total protein impurities

Animal-Free & GLP-like Production

Animal-origin-free production and GLP-style workflows with full documentation to support regulatory submissions and ensure compliance confidence

Custom QC Controls

Tailored QC options including sterile filtration, antibiotic residue testing (ampicillin/kanamycin), mycoplasma/phage detection aligned to your specific release criteria

FAQ

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