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:
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Independent GMP plasmid production workshops
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High-density fermentation process with yield > 1g/L
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Highly-efficient continuous alkaline lysis technique with full parameter control. The lysis process can be scaled up linearly.
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Innovative two-step column chromatography purification optimizes time and cost efficiency
Production Technique Highlights
No animal components or antibiotics
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Single use and closed system
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Isolator for aseptic filling
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Animal components- free
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Antibiotics-free
High fermentation yield, multiple grades and scales
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High fermentation yield >1g/L
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Research-grade for in vitro or preclinical studies/GMP Plasmid for Phase 1-3 and commercialization
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Multiple scales: mg - 20g
Innovative two-step chromatography purification
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Innovative two-step chromatography purification
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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
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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.
Service | Research-Grade | IIT | IND |
|---|---|---|---|
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 | Nanodrop | >1mg/ml |
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 | A260/A280 | UV-Vis spectrophotometry | Sequence alignment is identical to the gene of interest |
Plasmid Purity | Supercoiled plasmid ratio | HPLC | 1.8-2.0 |
Plasmid Purity | Residual host protein | ELISA | >85% |
Plasmid Purity | Residual host DNA | qPCR | <1%w/w |
Plasmid Purity | Residual host RNA | Electrophoresis | <1%w/w |
Endotoxin | Endotoxin | Gel clot LAL | <10EU/mg |
Sterility | Sterility | Bacterial and fungal culture tests | Negative |
pH | pH | pH meter | 7.0-8.0 |
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.
