Dana Rosencrance, VP of Quality and Operations Manager, Denise Ortlip, Director of Production, Michael Moxley, Director of Business and Process Development and Leslie F. Orischak, VP and General ManagerPuresyn’s unmatched expertise as a long-standing plasmid purification company in the U.S. has set the standard with its high quality plasmid DNA, and continues to aide in the advancements in drug research.
“We are the oldest DNA purifier in the U.S. with a rich history of working with our customers. We have a wealth of knowledge about plasmids, understanding our client needs and how best to assist them is key,” says Leslie Orischak, VP and General Manager, Puresyn.
Premium Plasmids under One Roof
Building on over three decades of DNA purification experience, Puresyn serves a diverse clientele, including biotech firms, principal investigators, and research scientists.
The contract plasmid DNA manufacturing company offers three core products and services— ResearchReady, TransfectionReady, and INDReady® DNA—distinguished for their superior quality.
For academic and research customers, the TransfectionReady program is a cost-effective means to obtain DNA for their investigative and exploratory work. Its remarkably quick turnaround time is a convenient option for customers who need small quantities of plasmid DNA.
The ResearchReady program is ideal for scientists and institutions engaged in discovery and research activities. It is highly customizable with three levels of specifications—basic, intermediate, and premium, which accommodates a wide range of research-grade DNA requirements.
Through its INDReady® program, Puresyn caters to customers developing plasmid vectors crucial for drug therapeutics targeting patients with cancer and genetic disorders. It supports the cell and gene therapy community with critical starting reagents to advance clinical trials and commercial productions. All processing components used to produce these plasmids are single-use with a cGMP mindset while adhering to the principles of GMP.
Puresyn handles numerous large-scale contracts for research institutions, and exclusively assists others aimed at treating small patient populations affected by rare orphan diseases. It works closely with customers to ensure plasmids are delivered on time, facilitating the production of essential drug products.
“Every member of our team is trained with a quality mindset. Our emphasis on delivering excellence is embedded in every step of our processes, from start to finish,” says Dana Rosencrance, VP of Quality and Operations Manager.
Its Quality Assurance Department remains actively engaged from initial contact and throughout the production process, rather than simply at the end for approval. This proactive stance is reflected in the design of its SOPs and procedures, where maintaining high standards is a fundamental and pervasive element.
Equally paramount is ensuring timely plasmid DNA manufacturing. Biotech firms often schedule virus production without considering the time required for plasmid production. Puresyn, with its rapid processing times, seamlessly coordinates with a customer’s existing product development pipelines to meet their timelines without compromising on quality.
Its deep understanding of regulatory requirements enables it to keep customers well-informed of the regulatory inquiries concerning materials use. Good scientific practices and comprehensive documentation practices in addition to the regulatory support they provide their INDReady collaborators help the drug owners gain approvals for clinical trials and product development. Puresyn is also aware of the challenges small biotech companies face in terms of funding. Whether pursuing grants or partnering with large corporations, they cautiously allocate their financial resources for plasmid production. Acutely aware of these challenges, Puresyn delivers on the promise of outstanding customer service through its cost-effectively designed initiatives.
A Legacy of Production Excellence
Its successful track record in the plasmid market is attributed to its exceptional purification capabilities, supported by PolyFlo®, a proprietary polymer technology resin.
With its resin manufacturing, Puresyn was able to develop a resin to simplify plasmid purification. Its distinctive chemical properties allow the separation of plasmid DNA from various impurities at a greater rate than commercially available resins. It holds an FDA Drug Master File for PolyFlo®, underlining its suitability for plasmid DNA manufacturing.
Producing this resin in-house enables Puresyn complete control over the logistics and supply chain across plasmid needs.
A longstanding partnership with a viral vector group attests to this advantage. Using PolyFlo®, Puresyn assisted the customer in inventory control and production management, efficiently maintaining a steady supply of critical reagents. Internally producing plasmids in bulk for storage in usable amounts that can be shipped at a moment’s notice eliminated the lag times due sometimes experienced from new productions, resulting in significant cost savings.
Backing Puresyn's production proficiency is its state-of-the-art ISO 8 Certified Cleanroom facility for INDReady® production, opened two years ago. This newly-built plasmid manufacturing facility reflects valuable feedback from customer audits and collaborator input, equipping the firm to adapt to their evolving plasmid needs and regulatory requirements.
Puresyn’s well-defined customer service is constant communication and a close-knit relationship with customers.
Every customer is viewed as a genuine collaborator. Instead of offering standardized services, Puresyn engages in one-on-one communication from the outset, which continues even after the purified product is delivered.
Many of its collaborators approach it with innovative ideas for drug therapies. As a valuable partner, Puresyn helps during their early decision-making stages, guiding them through the plasmid lifecycle. Clients gain a profound clarity of every aspect of their plasmid production, which comprehensively benefits their research journey.
We are the oldest DNA purifier in the U.S. with a rich history of working with our customers. We have a wealth of knowledge about plasmids, understanding our client needs and how best to assist them is key
Its sheer volume of plasmid purifications is a testament to its expertise that inspires the word-of-mouth recommendations that drive its growth. Unwavering support from its customer base has garnered Puresyn a strong reputation and credibility in the industry.
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Every member of our team is trained with a quality mindset. Our emphasis on delivering excellence is embedded in every step of our processes, from start to finish
Puresyn is actively expanding its plasmid DNA purification services while forging partnerships with global collaborators.
Key Pillar of Breakthroughs
A key factor contributing to Puresyn’s longevity is its accomplished team, each with educational backgrounds in distinct scientific disciplines.
A small and adaptable nature empowers the team to function cohesively, prioritizing a healthy work-life balance. All employees, including scientists and production staff, are treated equally to foster an environment where every department works collaboratively to ensure contracts are fulfilled on time.
With its quality plasmid services and a results-driven team at the helm, Puresyn stands as the frontrunner for clientele across the industry looking to jointly explore promising avenues in cell and gene therapy for drug innovation and research.
