Puresyn, Inc.
Optimizing Life Science Research with High- Quality Plasmid-DNA

The ever-evolving cell and gene therapy domain drives the need for rapid and reliable plasmid- DNA development. Achieving this without a partner capable of overcoming the inherently slow and expensive production process is an uphill task.

The oldest plasmid purification company in the U.S., Puresyn Inc., addresses this need with its expertise-backed contract plasmid-DNA production services, which have proven to boost life science research.

“We optimize and scale client projects by providing high-quality plasmid-DNA for all phases of GMP vector production,” says Leslie F. Orischak, VP and General Manager at Puresyn.

Puresyn’s comprehensive plasmid-DNA manufacturing services, INDReady^®, ResearchReady, and TransfectionReady, enable Puresyn to produce plasmids across different research and project specifications. Whether the need is for GMP-like, high-quality, or fast and convenient plasmid DNA, Puresyn’s services satisfy all the requirements.

The timely delivery of starting materials for critical manufacturing stages, typically for the development of viral vectors, Puresyn helps to prepare for the next research phase. It eliminates bottlenecks in plasmid manufacturing as the fast turnaround time provides clients with much-needed peace of mind.

Puresyn performs its plasmid-DNA services under a stringent quality system. Puresyn has a team of experts who possess a quality mindset and strive to achieve excellence throughout production.

PolyFlo^®, a proprietary polymer technology, is another key facet of its emphasis on quality. It purifies plasmids that produce highly pure DNA that meets and exceeds the specifications of a project.

Puresyn’s quick and reliable turnaround assures customers that they can proactively plan subsequent manufacturing steps or clinical trial milestones. The company also benefits clients looking to develop a forward-looking compliance posture for their future GMP manufacturing objectives.

Puresyn excels at helping collaborators remain compliant with evolving regulations on starting materials. Puresyn routinely supports collaborators and provides answers from regulatory agencies regarding the plasmid starting material. Michael Moxley, Director of Business and Process Development, adds, “Puresyn has ensured that our INDReady sup>® services adhere to regulatory mandates and help keep collaborators in compliance for their future downstream GMP manufacturing.”

Puresyn has supported collaborators’ filings in Phase I, II, and BLA submissions. The company’s expertise and dedication proved invaluable for the client, Puresyn’s VP of Quality and Operations Manager, Dana Rosencrance, highlights how they act as a ‘collaborator’ and work closely with every client throughout a research project. From signing a confidential disclosure agreement (CDA) and understanding their needs and project requirements to delivering the final plasmid, the company provides a transparent and reliable process. It also keeps clients updated on the status of their orders, emerging issues or questions, and the expected delivery date.

“We meet client needs with our unmatched timeline flexibility. Our collaborators call us frequently during production and ask for a change or urgent delivery. Whether they want to send samples to another location or change their shipping requirements, we adapt our whole team to any last-minute requests and ensure the samples or final product reaches their destination on time,” says Dana Rosencrance.

Denise Ortlip, Director of Production, also notes, “As far as the production timeline, we make sure that we are on schedule, and we’re in constant communication to ensure that we’re meeting those timelines. We always work with an urgency and quality mindset.”

Puresyn understands that success does not solely lie in the quality of the final product but also in the experience it delivers to customers. This principle drives superior customer-centricity and excellent service, empowering the company to defy the odds and outlast market competitors.

Its leadership combined cell and gene therapy expertise and valuable insights propel Puresyn as a key accelerator of scientific discoveries. The company aims to empower more researchers to achieve their goals and bring life-changing therapies to the market through collaborative and expertise-backed plasmid-DNA services.