GMP Plasmid Production

In the last decades, both gene therapy and cell therapy have emerged as attractive treatment options for a variety of diseases. In addition to the commonly used viral vectors, non-viral gene delivery methods using plasmid DNA are particularly interesting because they are often cheaper and faster to produce. For clinical applications, Good Manufacturing Practice (GMP) grade plasmid DNA is required.

Creative Biogene has extensive experience and expertise in producing plasmid DNA for a variety of applications. We provide quality plasmid DNA development services for preclinical, clinical and commercial production. We are committed to applying our plasmid DNA development capabilities to the manufacture of viral vectors for gene therapy and also for the development of novel DNA or mRNA vaccines and non-viral gene therapy applications, thereby helping our clients to accelerate their high-end program development process.

Service Scope

Creative Biogene has accumulated over a decade of experience in the field of GMP plasmid production. Our strong development capabilities allow us to provide different levels of plasmid DNA development services to a variety of clients. Our experienced scientists have the flexibility to handle various levels of plasmid DNA development projects as follows:

Non-GMP Plasmid Production

Non-GMP plasmids are mainly used in basic research, preclinical research and drug discovery studies.

GMP-like Plasmid Production

GMP-like plasmids are suitable for use in preclinical research phases, such as researches to test drug safety and metabolism in animals. Plasmids of this grade can be used as starting material for the production of clinical viral vectors.

GMP Plasmid Production

GMP level plasmid preparation requires production in a production plant that has been validated to meet GMP requirements, mainly for the industrial production phase.

Service Process at Creative Biogene

Creative Biogene offers one-stop services for plasmid DNA production. We are committed to providing high-quality solutions to meet any of our clients' demands in the manufacturing process of plasmid DNA from bacteria to final filtration. We can minimize the time required for project delivery and provide cost-effective plasmid DNA.

Vector Identification

Enzyme digestion identification
Sequencing

Process Development

Vector optimization
Culture system optimization
Production process optimization
Analytical method development
Stability research

Cell Bank Establishment

Primary cell bank (PCB)
Master cell bank (MCB)
Working cell bank (WCB)

Plasmid Production

Plasmid non-GMP production
Plasmid GMP-like production
Plasmid GMP production

Quality Control

Physical properties
Characterization
Purity testing
Safety testing

Why Choose Us

With over 10 years of expertise in plasmid DNA manufacturing, is able to provide solutions for different levels of plasmid DNA production.
With scalable 1mg to 1kg and efficient production platform.
Low shear force for maximum plasmid DNA recovery.
Comprehensive quality assurance, contamination-free production and high batch-to-batch consistency.

As a trusted provider of GMP plasmid manufacturing services, Creative Biogene is committed to providing cost-effective, high-quality and efficient outsourcing solutions to meet any of our clients' demands and priorities in the biologics and drug development pipeline. 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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