Quality and compliance
Exceptional standards for high-quality plasmid DNA at every stage of development
Puresyn has superior and well-established systems, processes and procedures to ensure high-purity plasmid DNA at the right scale and specification for your needs. We take your plasmid DNA personally.
cGMP-compliant services for late-stage clinical trials through commercialization
Puresyn’s cGMP production facility is a 10,000 sq. ft., ISO Certified (ISO 14644-1:2015) cleanroom designed around plasmid DNA regulatory compliance with Current Good Manufacturing Practices (cGMP).
GMP is the primary regulatory standard for ensuring pharmaceutical quality. As the US Food and Drug Administration states, these regulations provide for “systems that assure proper design, monitoring, and control of manufacturing processes and facilities.”
How does Puresyn ensure high-purity plasmid DNA?
Our exceptional quality system ensures that Puresyn pDNA products meet or exceed our established specifications.
Our production process follows best practices and stringent quality control to ensure high-quality plasmid DNA from fermentation and harvesting through the final quality test, aliquot and label.
Proprietary PolyFlo® resin delivers exceptional purification control
The cornerstone of Puresyn’s company history, PolyFlo® resin is used in all ResearchReady, INDReady® and cGMP plasmid DNA manufacturing. The unique properties of PolyFlo® resin help streamline the chromatography process for greater efficiency while ensuring higher quality.
PolyFlo® resin is on file with the FDA, DMF 13090.
Our quality system maintains strict governance to ensure purity, consistency, stability and integrity.
We work with our collaborators to ensure the products and services we provide are of the highest quality possible to advance their research. We do this by utilizing good scientific practices and adhering to all applicable government regulations.
To ensure traceability and accountability, Puresyn keeps proper records of every detail in the production and quality control process. We also maintain comprehensive document management procedures to keep those records safe and available, for all INDReady® and cGMP contracts.
- All contract documentation is stored on-site, with restricted access, in fireproof storage
- Contract documentation is scanned and stored electronically indefinitely
- All electronic data is backed up daily and stored in a cloud-based archive
- Regulatory documentation package available for INDReady® and cGMP plasmid DNA
Our proactive QA procedures are built into the production cycle at every stage. This approach helps Puresyn maximize plasmid yields and systematically detect, address and prevent quality issues. Our quality assurance procedures include:
- Process deviation system (PDR)
- Process change control (PCC)
- Laboratory investigations (OOS)
- Corrective and preventive action (CAPA)
- Equipment maintenance and relocation tracking
- SOPs and controlled document procedures for drafting and revising
- Internal quality audits
- Management review of quality audits
- Product recall procedure
- Business continuity and disaster recovery plan
- Risk management
- Contamination control
INDReady® plasmids exceed FDA and EMA regulatory guidelines for GMP vector production
We are dedicated to continual improvement
Through collaborator input and ingenuity, we constantly seek out ways to improve our products and services. Our dedication to achieving the highest levels of quality through teamwork and innovation shows in everything we do.
The future of cell and gene therapy depends on GMP plasmids
As demand for GMP production continues to rise, providers who have yet to upgrade may fall behind. The time and cost required to deliver cGMP production may prove too difficult.
On the other hand, those manufacturers who have already taken the steps to full GMP production are well-poised to serve clients across the entire development cycle and into the future.
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.
