Capacity at every stage from discovery through commercialization
Puresyn offers the right grade of plasmid DNA based on your phase of development. From discovery through commercialization, there is a quality Puresyn option right for your work.
TransfectionReady plasmid DNA
Convenient and cost-effective, this small-scale TransfectionReady plasmid DNA service replaces hours of research time lost performing in-house purification kits. Available in two scales, with a rapid turnaround time to speed efficiency in the discovery phase.
ResearchReady plasmid DNA
Suitable for a variety of research applications in the Development phase, ResearchReady plasmid DNA is a large-scale service that utilizes our proprietary resin, PolyFlo® (DMF 13090), and results in highly pure DNA meeting the agreed-upon specifications. (Ready-to-ship ResearchReady packaging plasmids coming soon.)
INDReady® plasmid DNA
As your work moves to late-stage clinical trials, our quality system ensures your plasmid DNA is manufactured in compliance with fundamental cGMP principles and Puresyn SOPs. INDReady® supports preclinical and clinical applications. (Off-the-shelf INDReady® packaging plasmids coming soon.)
cGMP plasmid DNA
Driven by a comprehensive quality assurance system, we produce cGMP plasmid DNA in a fully dedicated ISO Certified cleanroom facility, ensuring the highest quality products and regulatory compliance support. Combined with our industry-leading experience and renowned customer service, Puresyn cGMP plasmid DNA meets the needs of late-phase clinical and commercialization for critical starting material and Phase I API requirements.
A resin like no other
Puresyn custom plasmid DNA services are built on our proprietary PolyFlo® resin — on file with the FDA, DMF 13090.
PolyFlo®: 30-plus year reputation for excellence
Puresyn started with the creation of our proprietary PolyFlo® resin over 30 years ago and has since earned a reputation for providing high-quality custom plasmid DNA services with an exceptional level of personal service and attention. We have never wavered from these values, and they continue to guide us as we work side-by-side with our collaborators in their quest for the next breakthrough.
Additional services
Puresyn offers a variety of services to help ensure quality and compliance for your plasmid DNA.
Production optimization evaluation
Our experts can evaluate your plasmid to assess a host cell and growth temperature for quality and yield, in order to achieve approval for INDReady® or cGMP plasmid production candidates.
On-site microbial cell banking
Puresyn can generate, store, and characterize your microbial cell banks through all clinical phases. Let our experts help you stay in compliance and ensure the longevity, purity, and accessibility of your critical starting materials.
Sequencing and testing
- Sequencing at any stage of production to ensure your plasmids are correct.
- Mycoplasma testing to verify the absence of prokaryotic organisms in your final product.
- Sterility testing to verify the absence of contamination in your final product.
- Stability testing with advanced analytics that monitor plasmid storage and provide real-time data on any potential variations.
Through all phases of clinical studies, Puresyn supports compliance by generating, storing, and characterizing the microbial cell banks used for your plasmid production, right here in our facility.
Top 5 considerations when choosing a plasmid DNA service provider
1. Experience and focus
When you’re entrusting your work to a plasmid DNA manufacturer, it’s a good idea to check their track record. How long have they been in business? How many customers have they supported through clinical trials and compliance procedures? Is plasmid DNA production their core service, or is it merely a bolt-on to a whole suite of services? Your research needs are your primary concern, and they should be the same for your provider. And deep experience with plasmid DNA means a provider that’s seen and done it all, so you can trust their advice.
2. Real, sleeves-rolled-up collaboration
Research and discovery work is a team sport. Your plasmid DNA provider should care enough to get to know your team, your process and your goals. They should be ready and willing to help you sort out your regulatory strategy and navigate complex challenges. All of that factors into delivering just the right material for your research.
3. Capacity from discovery through commercialization
Nobody should have to start over with a different plasmid DNA provider once your research moves into later stages of development. It’s a big headache (and potentially a timeline destroyer). Working with a single trusted provider can help you save time and money, while streamlining communications — because your partner already knows and understands your research.
4. Responsiveness and turnaround
There are times when your plasmid DNA needs are absolutely urgent. When considering a provider, ask whether they can manage production to your timeline. Notice whether they return calls promptly or leave you hanging. If a company can’t respond quickly to even a simple question, you may not want to trust them with your deadline.
5. Comprehensive testing
Your work deserves accurate guaranteed specifications, sequencing, contamination testing and highly advanced storage and stability capabilities to maintain your standards, address regulatory requirements and help ensure the success of your research or application.