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The process of plasmid production consists of a complex series of steps including fermentation, alkaline lysis, clarification, concentration, chromatography, purification, and concentration & replacement. Any one of these steps is critical to the quality and purity of the final product. Creative Biogene offers process development services to help optimize the plasmid production process and maximize the yield, purity and reproducibility of plasmid products. Our project experts are in constant communication and collaboration with our clients to optimize their plasmid production process and to ensure consistent and reproducible quality.
Upstream fermentation process development
The fermentation process development approach for plasmid GMP (Good Manufacturing Practice) production can vary depending on the specific requirements and goals of production process which mainly include the following:
Among them, fermentation is optimized in the areas of media, culture methods, nutrients, dissolved oxygen, pH, temperature, and metabolites. In addition, Creative Biogene carefully optimizes the processes and conditions involved in each step of the upstream process in GMP plasmid production to ensure high quality and consistent product yields.
Downstream purification process development
In order to obtain high-quality plasmid products, the best solution is to have a robust overall process in which each step is well optimized. A well-optimized downstream process is essential to purify the superhelical plasmid DNA in high yield to obtain the desired therapeutic/transfected form. Creative Biogene offers unique solutions for multiple steps of the downstream process of plasmid production to ensure optimal plasmid yield and purity, including the following:
The most critical process for plasmid process development is the lysis process, which takes advantage of the intracellular release of nucleic acids after lysis to separate the plasmid from the chromosomal DNA by taking advantage of the differences in denaturation and repetition characteristics of the plasmid and chromosomal DNA. Creative Biogene's lysis process uses classical alkaline lysis with a lysis efficiency of over 80%, ensuring better results for subsequent production.
The role of this part of lysis is mainly the release of plasmids and HCD removal, which is the most critical and core step of the whole downstream process recovery and HCD control. Creative Biogene has realized an industrially scalable continuous cracking process through a proprietary design device, and by optimizing key parameters such as dilution times, cracking ratios, cracking times, and neutralization times, the continuous cracking process can achieve a stable cracking efficiency of over 90% and HCD control at 0.5% after crude purification, with a stable process and scalable feasibility.
The application part of the TFF process tangential flow, including bacteriophage collection, lysis clarification, and concentration replacement. Creative Biogene's TFF process selects hollow fiber membrane columns and packs that can replace traditional centrifugation and ethanol precipitation methods. Improves process scalability and compliance during large-scale plasmid scale-up.
Most existing purification processes include a chromatography step. Creative Biogene's plasmid purification chromatography methods include anion exchange chromatography (AEC) and hydrophobic interaction chromatography (HIC), both techniques have been used for capture or intermediate purification, and are often used in combination.
Quality testing methods development
The quality and purity of plasmids are critical for successful transfection and other subsequent applications. To determine quality, Creative Biogene has developed and established a series of assessment methods and programs for rapid, accurate and reproducible testing of sample quality.
As your trusted partner, Creative Biogene can enhance your plasmid production process while ensuring high quality with our portfolio of proven solutions from process development to large-scale commercial production. 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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