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Non-GMP Plasmid Production

In the past years, the demand for small batches of clinical grade plasmid DNA has been growing. Creative Biogene's diverse plasmid development platform allows us to provide our customers with flexible and reliable non-GMP production of plasmids that can be used for basic research and early-stage drug discovery studies. Our non-GMP grade plasmids are manufactured under standard laboratory conditions with strict quality control throughout to ensure high quality product delivery for our clients.

Non-GMP Plasmid Production

Features of Non-GMP Plasmid Production

Creative Biogene's non-GMP plasmid production provides customers with high quality plasmid products ideal for your preclinical in vivo animal studies, gene therapy, cell therapy, and vaccine development. Our Non-GMP Plasmid products have the following features:

  • Non-GMP bacteria library generation
  • 2 L to 10 L glass bioreactors
  • Ultrafiltration and purification systems
  • Plasmid Process Development
  • IND filing document preparation

Non-GMP Plasmid Production Process

Creative Biogene uses well-sourced plasmid host strains according to our customers' demands. Our experienced scientists have developed a well-established non-GMP plasmid production Process to quickly deliver high quality and competitive custom plasmid products to our clients.

Non-GMP Plasmid Production

  • Seed culture

Creative Biogene uses our advanced plasmid development platform to select high-yield clones and seed them to provide sufficient cell numbers for inoculation into bioreactors.

  • Upstream fermentation

Creative Biogene offers flexible and reliable fermentation solutions from 2 L to 10 L fermentation batches. In addition, our experienced scientists can help clients optimize cell growth conditions quickly and reliably and maximize plasmid yields for robust and efficient production.

  • Harvest

After fermentation, we usually harvest the cells by centrifugation for subsequent development and production.

  • Bacterial lysis

The purpose of cell lysis is to release plasmid DNA and remove cellular debris and genomic DNA. Creative Biogene extracts plasmid DNA by alkaline lysis and uses it for subsequent production.

  • Clarification

Creative Biogene is committed to providing our clients with the best plasmid DNA clarification solutions through our advanced processes and proprietary platforms for purifying plasmid DNA in high-density cell cultures and removing cellular debris and impurity contaminants.

  • Ultrafiltration concentration

Steps such as concentration of plasmid DNA, removal of contaminants and buffer changes are critical in plasmid DNA production. Creative Biogene's innovative technology combines low-shear operation with fully containment processing to achieve the highest recovery rates in a closed system and to create the ideal environment for plasmid DNA production.

  • Downstream purification

Optimization of the purification process can improve plasmid yields and reduce costs. Creative Biogene provides comprehensive plasmid DNA purification solutions through a multi-step efficient and robust purification process, ultimately producing high-quality plasmid DNA extracts reliably for our clients.

  • Quality control analysis

Creative Biogene performs analysis throughout the purification process to determine the presence of impurities and to quantify the product. The information provided supports a robust, high-quality product.

Advantages of Creative Biogene

  • Expert team
  • Efficient and stable production
  • Strict quality control
  • Cost-effective

Creative Biogene's experienced team of experts has established a comprehensive and stable plasmid production service system to ensure high yields and quality non-GMP plasmid products for our customers. We can provide customized development solutions based on specific customer demands. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.
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