GMP Plasmid Production Process

Creative Biogene provides a full range of integrated services to meet the demands of customers at different stages of GMP plasmid production, including plasmid strain construction, clone screening, strain building, process development, quality control and analysis, and other processes.

Challenges in GMP Plasmid Production Process

Purity and yield of plasmids. Avoid contaminants such as bacterial endotoxins, host cell DNA and RNA that affect the quality of plasmid.
The production process must be robust, reproducible, and capable of producing high yields of plasmids in a consistent manner.
Quality control. Strict quality control measures must be in place to ensure the stability of GMP plasmids, their safety and the compliance of the production process with regulatory guidelines enforced by the health authorities.
Regulatory compliance. The manufacturing process needs to comply with regulatory compliance guidelines, those by FDA, EMA or Health Canada.
Production costs. GMP production requires additional resources, including specialized equipment, facilities and trained personnel.

Services Available for Plasmid GMP Production Process

As a leading provider of GMP plasmid production services, Creative Biogene has an independent plasmid development laboratory, GMP plasmid production cell bank establishment line and GMP plasmid production line. Our flexible and scalable production platform can be adapted to meet any customer's demands and can provide excellent service in the following production processes:

Plasmid Construction

Creative Biogene can perform GMP production based on existing plasmids provided by our customers. Alternatively, we can recreate any existing plasmid to increase productivity and meet diverse production demands by cloning the gene of interest into a proprietary vector provided by Creative Biogene, depending on the client's project needs.

GMP Plasmid Production Cell Bank Establishment

Creative Biogene has developed a proven platform for plasmid strain building and production. The platform includes the entire process of validated plasmid construction, plasmid transformation, clone screening, strain bank construction, seed bank preservation and quality testing. Once the plasmid construct is completed, we can immediately provide our clients with efficient GMP plasmid strain bank establishment services through this platform.

Process Development

Process optimization of plasmid production is of great importance to improve the yield and quality of plasmids. The biggest challenge in the plasmid production process is upscaling production and purification, i.e., maintaining a high percentage of superhelical structured plasmids while maintaining high purity. Creative Biogene leverages our extensive experience and technology to provide comprehensive solutions for fermentation processes, purification processes, and plasmid production processes.

Plasmid Production

Creative Biogene's independent GMP manufacturing facility is equipped with state-of-the-art manufacturing equipment and complete disposable processes. Our strong development capabilities allow us to provide our customers with GMP-grade, high quality, high purity plasmid products to accelerate and support their project development process.

Quality Control Solutions for Plasmid Preparation

Creative Biogene conducts stringent quality control throughout the GMP plasmid manufacturing process, including general/characterization, purity and stability analysis, to ensure that we provide our customers with high quality plasmid products that meet strict regulatory standards.

Creative Biogene offers a variety of advanced production tools to help achieve efficient production of GMP plasmids. Our scientists are committed to exploring the entire process from bacteria to plasmid production and assisting you with solutions for each step of the process. 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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