Ensure quality control and compliance throughout production
Puresyn experts are always ready to advance your research through our sophisticated evaluation, cell banking, sequencing and testing services. It’s all part of our commitment to stand side-by-side with you, serve the unique needs of your work and provide the highest quality plasmid DNA for your needs.
Production optimization evaluation
As you’re looking to move into INDReady® or GMP production, we’re happy to evaluate your plasmid to assess a host cell and growth temperature for quality and yield.
Our 3-step evaluation process
Evaluate provided plasmid
- Perform up to four restriction digests on your plasmid.
- Compare results with the expected fragments.
- Sequence confirmation is optional.
Manufacture a cell bank
Using your requested host cell and temperature (or our recommendation)
- Select two colonies for glycerol manufacture — or — produce a master cell bank and working cell bank for cell banking requests.
- Run a TransfectionReady prep for each glycerol and confirm the identity with restriction digest analysis.
- Sequence confirmation is optional.
Initiate a pilot run
(12L fermentation)
- Confirm plasmid identity with restriction digest.
- Sequence confirmation is optional.
At each step, we can conduct sequencing analysis to confirm plasmid identity and rule out potential variants and cross-contamination. Multiple host cells and/or temperatures can be requested for additional fees.
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 at any stage of development
Our team can provide sequencing and testing to help maintain integrity and compliance in your final product. Our decades of experience across thousands of different plasmids ensure streamlined performance. Sequencing can confirm your plasmid identity and rule out potential variants.
Mycoplasma testing
Verify the absence of prokaryotic organisms in your final product.
Sterility testing
Ensure your final product is free of microorganism contamination.
Stability testing
Plasmid storage tracking and advanced analytics are built into our on-site, state-of-the-art monitoring system, providing real-time data on potential variations. Using this data, we provide detailed, comprehensive stability reports to help you demonstrate regulatory compliance.
Plasmid DNA services for every stage of development
Quick-turn purifications at a small scale
Larger-scale research plasmid service
GMP-like services for clinical trials
