Plasmid DNA manufacturing plays an essential role in biopharmaceutical research as well as the production of a wide range of innovative treatments and therapies. Because pDNA is such a flexible carrier for genetic material, it plays a vital role in viral vector and mRNA-based approaches.
Puresyn plasmid DNA manufacturing for early- to late-stage development
For early-stage development and preclinical studies, researchers rely on plasmid DNA manufacturing to produce pDNA to their precise specifications under controlled lab conditions. Our ResearchReady research-grade plasmids are useful for transfection experiments, protein production, gene expression studies, antibody generation, and toxicology studies.
Moving into clinical trials, plasmids transition into in-vivo use. As a result, plasmid DNA manufacturing might scale up to larger quantities while adhering to more stringent quality and compliance standards. From late-stage trials through commercialization, GMP production becomes necessary to ensure the highest plasmid quality and safety.
Puresyn plasmid DNA manufacturing for clinical and commercial applications
All of our INDReady® and GMP pDNA preparation and production takes place in our ISO Certified cleanroom facilities. We have eight dedicated production suites, made up of an airlock, purification laboratory and fermentation/lysis laboratory. The facility also includes two comprehensive suites for fermentation initiation and cell bank manufacture, as well as a quality control sampling and storage lab.
INDReady® production initiation
Once an order is initiated, the first steps of any new INDReady® or cGMP plasmid DNA production are focused on evaluating our collaborator’s starting material and completing a pilot run.
The Puresyn plasmid production process
All ResearchReady, INDReady® and cGMP plasmid DNA manufacturing utilize our patented PolyFlo® resin for exceptional purification control, process efficiency and exceptionally high quality.
Leverage our expertise and dedication to quality
Puresyn incorporates a stringent quality system in every aspect of our products and services and is committed to providing our collaborators with products and services of the highest quality. To meet that goal, all Puresyn functions are performed under the umbrella of our quality system.
- Puresyn maintains high standards to ensure that products meet or exceed our established specifications and those of our collaborators.
- We work with our collaborators to ensure the products and services we provide are of the highest quality possible to advance research.
- Puresyn achieves high quality through adherence to all applicable Puresyn policies and procedures, utilizing good scientific practices, and adhering to all applicable government regulations.
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Let our experienced team help you take the next steps to meet your plasmid DNA needs.