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GMP Plasmids

Plasmids are one of the most important tools in the field of gene therapy. The rapid growth of the gene therapy industry, including the rise of mRNA vaccines, has greatly stimulated the market demand for GMP plasmids. uBriGene focuses on developing mass-production techniques for clinical-grade GMP plasmids. We offer a platform of integrated production techniques and quality control systems to provide you with GMP plasmids from milligram- to gram-scale.

Production Workflow

uBriGene’s GMP plasmid production process includes upstream and downstream fermentation processes. We have:

  • Independent GMP plasmid production workshops

  • High-density fermentation process with yield > 1g/L

  • Highly-efficient continuous alkaline lysis technique with full parameter control. The lysis process can be scaled up linearly.

  • Innovative two-step column chromatography purification optimizes time and cost efficiency


Production Technique Highlights

No animal components or antibiotics
  • Single use and closed system

  • Isolator for aseptic filling

  • Animal components- free

  • Antibiotics-free

High fermentation yield, multiple grades and scales
  • High fermentation yield >1g/L

  • Research-grade for in vitro or preclinical studies/GMP Plasmid for Phase 1-3 and commercialization

  • Multiple scales: mg - 20g 

Innovative two-step chromatography purification
  • Innovative two-step chromatography purification

  • Same quality standard as the three-step process, faster and with only 15% of the cost

Scaled up while ensuring plasmid purity, efficacy and yield
  • Can be scaled up while ensuring plasmid purity, efficacy and yield

IIT and IND Filing Services

IIT non-registered clinical study / investigational new drug (IND) application / gene therapy commercialization

uBriGene has proficient and experienced Regulatory Affair teams in North America and China. We filed 2 out of the 4 approved IND applications for AAV gene therapy products in China in 2021.[client names]  In 2022, we will file four more IND applications to FDA on behalf of our clients.

PCB Construction and Inspection
MCB and WCB Construction and Inspection
Based on client's inquiry
Cell Bank Passage Stability Analysis
Based on client's inquiry
Plasmid Production Optimization
Manufacturing Process Confirmation; Batch Production
Based on client's inquiry
Plasmid Production And Verification (For Application)
Batch Production Records
Based on client's inquiry
Batch Inspection Records
Based on client's inquiry
Quality Inspection Records
Relevant Traceable Documentation
Based on client's inquiry

Quality Control and Quality Assurance

uBriGene's one-stop gene therapy CDMO service platform has rigorous and professional QA and QC teams to meet the testing requirements of all GMP plasmid projects. We have completed the methodological development and verification of more than ten GMP plasmid products. We also provide relevant data used for your IND application. Some testing items and methods for GMP plasmids are listed below.

QC Category
QC Category
QC Method
QC Standard
Plasmid Appearance
Plasmid Appearance
Visual inspection
Clear, colorless liquid, free of foreign particles, turbidity or precipitates
Plasmid Concentration
Plasmid Concentration
Plasmid Identity
Plasmid Identity
Restriction digest analysis
Product size is consistent with insert fragment
Plasmid Identity
Plasmid Identity
Sanger sequencing
Sequence alignment is identical to the gene of interest
Plasmid Purity
UV-Vis spectrophotometry
Sequence alignment is identical to the gene of interest
Plasmid Purity
Supercoiled plasmid ratio
Plasmid Purity
Residual host protein
Plasmid Purity
Residual host DNA
Plasmid Purity
Residual host RNA
Gel clot LAL
Bacterial and fungal culture tests
pH meter

Project Cycle

uBriGene has extensive experience in GMP virus production and release, and can provide complete clinical-grade viral product manufacturing services, including cell bank construction, technology and methodology development, stability studies, pilot batch production, and customized services to be provided based on project needs. In addition, in order to meet the requirements of IND application, uBriGene also provides clinical-grade AAV batch production documentation, batch inspection records and related certification. Please see the table below for a typical project cycle outline.

ProjectCycle-GMP Plasmid.png
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