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GMP Plasmids

As a crucial starting material for many advanced therapies, plasmids are one of the most important tools in the field of cell and gene therapy (CGT). The rapid growth of the CGT field has stimulated large demand of plasmid production. From adenovirus, adeno-associated virus, lentivirus viral vectors to chimeric antigen receptor (CAR) cell therapy, plasmids are a vital first step.

At uBriGene, our expert specialists can provide custom plasmid productions that fit your project specifications. We offer integrated manufacturing platforms and quality control systems for plasmid productions from milligrams to gram scales. Our systems allow for ease of scale-up and mass-productions for any quality of plasmids your project requires; from research-grade to non-GMP/GMP-like to full GMP grade plasmids.

Production Workflow

uBriGene’s GMP plasmid production process includes upstream fermentation and downstream purification processes. Our Isolated and separated plasmid production floor contains fermentation tanks of up to 200L capacity. Single use fermenters can also be used to further reduce risk of cross-contamination. Our high-density fermentation process can yield plasmid concentrations of >1g/L. Alkaline lysis allows for full parameter control of downstream plasmid purification process with ease to scale up linearly.

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Our two-step column chromatography purification allows for time and cost-efficient optimizations. With the same quality standard as a three-step purification process, our in-house manufactured resin provides ~85% cost reduction in plasmid production.

Production Technique Highlights

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High Sterility and Quality
  • Single use closed systems

  • Completely isolated aseptic filling systems

  • Antibiotic and animal component-free

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High Cost Efficiency
  • Innovative two-step purification process

  • Reduced time and cost of manufacturing

  • Up to 85% lower cost of plasmid purification

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Scalability
  • High linear scalability

  • High fermentation yield >1g/L

  • Multiple scales of mg to 20g capacity

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Multiple Grades
  • Research Grade

  • Non-GMP/GMP-like Grade

  • Full GMP Grade

Cell Banking

uBriGene also provides Cell Banking services with plasmid production. For Primary Cell Bank (PCB), Master Cell Bank (MCB) and Working Cell Bank (WCB) construction for plasmid production, see our Cell Banking webpage.

Quality Control and Assurance

With our one-stop shop solution to our client’s cell and gene therapy needs, we provide the highest quality QA and QC support. Our dedicated and experienced quality teams assist our clients in developing testing methods to meet even the most stringent requirements of GMP projects.

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, BriGene 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.

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