pDNA Overview & Offerings

At Akron, we manufacture high-quality cGMP compliant plasmid DNA for pre-clinical, clinical, and commercial gene therapy and vaccine companies where material needs are 1+ grams.

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 Difference

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.

Akron’s cGMP plasmid development and manufacturing services include:

  • Highly trained process development scientists and manufacturing engineers
  • Inbound technology transfer and seamless scale-up
  • Robust process optimization to achieve desired critical quality attributes while maximizing yield
  • Manufactured in segregated, validated and 24/7 monitored cleanrooms
  • State-of-the-art single use Cytiva FlexFactory upstream platform (50-200L) and flexible downstream options
  • Defined and validated critical process parameters (temperatures, times, agitation rates, etc.)
  • Full scale engineering and process validation capabilities to enable cGMP production
  • Procurement and management of cGMP grade materials sourced from audited and qualified suppliers
  • Client specific batch record and documentation with CoA upon full quality release
  • Generation, characterization and storage of master and working cell banks
  • Full suite of analytical testing capabilities including assay qualification and validation

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.

  • CYTIVA FLEXFACTORY UPSTREAM – 50L and 200L Disposable Bioreactors XDR (MO) from Cytiva for application- and program-appropriate batch size
  • ÄKTA DOWNSTREAM – ÄKTA Pilot systems for process development and ÄKTA Ready single-use liquid chromatography systems for scale-up and manufacturing

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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.

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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.

  • Leverage our seasoned PD and manufacturing team to optimize and manufacture even the most difficult plasmids. ITRs, LTRs, low copy number plasmids? Not a problem. Our team will optimize your process to meet your critical quality attributes and product criteria.
  • At Akron quality is always paramount. We've designed our quality systems and team to ensure quality throughout all stages of our services. Akron's quality team is committed to working seamlessly with our clients and able to offer exceptional quality and regulatory support on demand.
  • Our operations and facilities management team is comprised of leaders from both big-pharma and biotech to ensure a rich and informative blend of perspectives needed to support a range of company types from start-up gene therapy companies through commercial vaccine developers.
  • Akron’s commercial and leadership team is comprised of highly experienced cell and gene therapy professionals that truly understand your needs and are committed to overseeing all projects, ensuing best-in-class performance and management regardless of project size.

Read about our leadership team

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