cGMP Facility and Infrastructure

State-of-the-art cGMP facility designed for gene therapy and vaccine production

With an exponential increase in demand for cGMP Plasmid DNA, Akron launched a pDNA manufacturing facility in early 2020 to accelerate clinical and commercial development of advanced therapies.

Akron’s new state-of-the art-facility raises the bar on quality and safety by integrating Cytiva’s flexible, single-use FlexFactory and TrackWise Digital Quality Management System to enable cGMP-compliant production for both ex vivo and in vivo applications.


Akron's Upstream pDNA Suite Animation


Akron's Small Downstream pDNA Suite Animation


Akron's Large Downstream pDNA Suite Animation



Facility Features:

  • LARGE FOOTPRINT WITH EXPANSION CAPACITY – New 60,000 sq. ft. facility with 50,000 sq. ft. expansion currently underway
  • MULTIPLE CLEANROOMS – Several cleanrooms with independent air handling systems (11 AHUs) for segregation control into multiple zones (15,000 sq. ft.)
  • USP WATER FOR INJECTION – WFI distribution loop supplied by Evoqua Puritas VRx with CDILX producing 15 L/min
  • CGMP QUALITY CONTROL LABORATORY – Full suite of pDNA-centered analytical development, qualification, and validation capabilities in-house


Equipment:

  • CYTIVA FLEXFACTORY – 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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