We constantly aim to offer an unparalleled customer experience and deliver product with exceptional yield and purity on time, every time.
Our excellence is deeply rooted in our people, our process, our quality system, and our technology infrastructure – it’s the combination of these factors that makes the Akron Difference.
If you’re looking for cGMP compliant plasmid DNA manufacturer, please contact us today.
Akron’s pDNA facility is engineered to address the needs of the gene therapy and personalized vaccine markets, manufacturing plasmid DNA under cGMP compliance for ancillary material or drug substance applications.
Our facility is thoughtfully designed for gram scale production and advanced therapy technologies that benefit from single-use disposable upstream production with flexible downstream options.
At Akron we put our customers and their patients first. We listen and adapt to ensure development, engineering, and validation align with clinical timelines and commercial requirements. Our approach ensures the right product at the right time for your pre-clinical, clinical, and commercial programs.
Akron has developed a best-in-class process that is flexible by design with various qualified strains to ensure compatibility with your plasmid. Our customers benefit from increased yields, higher purity and higher percentage of super-coiled DNA relative to other platforms on the market.
Our Sarasota manufacturing facility is US FDA and EU cGMP compliant with a 60,000 sq. ft. footprint and an 50,000 additional sq. ft. available for expansion. Our current buildout encompasses 15,000 sq. ft. of cleanroom space plus QC labs in conjunction with a 3,400 sq. ft. fully contained GLP process development laboratory. The cleanrooms are each separated into multiple zones with separate air handling systems for control and segregation.
Akron has incorporated a suite of best-in-class electronic systems to support the management of Operational and the Akron Quality Management System, including TrackWise (eQMS), LabVantage (LIMS) Blue Mountain (Asset Management), Rockwell Automation (BMS), and SAP (ERP). We are committed to manufacturing pDNA employing top-of-the-line equipment and systems under a cGMP-complaint QMS to ensure quality and reliability of supply, every time.
The Akron team, comprised of industry-leading experts, is committed first and foremost to delivering a customer experience that’s unrivaled in the industry. Whatever your plasmid challenges may be, our experts can help.