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GMP plasmid production involves multiple production steps and advanced technology, requiring specialized production facilities and trained personnel. Creative Biogene has an independent GMP plasmid production facility and platform, a validated high-density fermentation process and strict quality control throughout the production process. We can provide our clients with GMP-grade plasmid products of high quality and purity. Our professional, efficient and experienced team of experts can provide flexible and variable production services to accelerate our clients' plasmid production and development projects according to their demands.
Creative Biogene has extensive experience in the development and production of plasmids strain construction, fermentation culture and purification. We have developed a production process that uses a high-density fermentation process and two-step chromatography to significantly increase plasmid yields and rapidly produce GMP-grade, high-quality plasmid products for our clients.
Creative Biogene has flexible and variable production scale with 5L-200L fermenters to meet different clients' production demands.
Cell harvesting steps typically use centrifugation or tangential flow filtration (TFF). By using hollow fiber assemblies for tangential flow filtration, we create a gentle pathway that reduces the effects of shear forces, mitigates membrane contamination and can be used to process highly viscous fermentation broth.
Creative Biogene uses a classical alkaline lysis method with optimized lysis incubation time and optimal control of lysis pH to rapidly lyse host cells, release plasmid DNA and remove cellular debris and genomic DNA.
Our advanced tangential flow filtration (TFF) equipment effectively separates impurities from high-density cell lysates and can effectively reduce shear forces to avoid damaging the structure of superhelical plasmids.
Creative Biogene offers technologies such as anion exchange chromatography (AEC) and hydrophobic interaction chromatography (HIC) that can be effectively used for capture or intermediate purification. We can provide relatively high separation resolution and efficient removal of proteins, low molecular weight RNA and endotoxins based on the use of chromatographic modes with different principles alone or in combination.
Creative Biogene offers the perfect decontamination filtration solution with our advanced decontamination filters that help customers meet the challenges of large end-product sizes, high viscosity, and shear sensitivity.
Creative Biogene has several GMP suites available to perform fermentation, purification and filtration operations, including facilities for fermenters of various sizes, continuous centrifugal cell harvesting, alkaline cell lysis, tangential flow filtration clarification, liquid chromatography purification, etc. All GMP production facilities and technologies have been inspected and certified by the relevant authorities and are approved for GMP plasmid production.
Creative Biogene's strong manufacturing capabilities allow us to provide access to difficult to produce plasmid DNA. Our extensive experience in plasmid production has allowed us to easily obtain the following plasmid products for our clients:
Creative Biogene has the flexibility to handle plasmid production projects of all sizes. Our one-stop manufacturing process minimizes lead times and provides high quality plasmid products. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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