The Capacity for Bigger Breakthroughs

Aldevron's 14-acre Breakthrough Campus - a Highly Advanced GMP Manufacturing Facility. 

We have been supporting our clients and meeting demand since our inception in 1998. Our current 75,000 square-foot, GMP manufacturing facility has been producing the highest quality pDNA since opening in 2018, to help meet worldwide demand. Our 189,000 square-foot expansion features industry-leading innovations and significantly increases production. This manufacturing facility was visited by the Center for Biologics Evaluation & Research (CBER) in November 2021. CBER conducted a Pre-License Inspection (PLI) and a general GMP audit of Aldevron, LLC. No Form FDA 483 was issued, and the inspection was classified as no action indicated (NAI).

Current Facility - Fargo

GMP/GMP-Source® Production

  • 75,000 square feet 
  • Multiple 30 L and 300 L single-use, bacterial fermenters 
  • State-of-the-art modular cleanrooms with single-pass air for cell banking, inoculation and fill/finish 
  • Advanced independent air handling systems with unidirectional personnel flow and airlocks within the GMP area 
  • Integrated building management system and environmental monitoring 
  • Quality control testing laboratory, large interior mezzanine for validated utilities.  
  • Produces clinical and commercial products in GMP-Source and GMP quality grades 

Capacity Expansion - Fargo

GMP Production Suites and mRNA Production Suites Fully Operational

  • 189,000 square feet of manufacturing, warehouse and logistical space 
  • Multiple 30 L and  300 L single use bacterial fermenters 
  • Significantly increases current manufacturing capacity 
  • Most advanced independent air-handling system with unidirectional personnel flow and airlocks within the GMP area 
  • State-of-the-art modular cleanrooms with single-pass air for cell banking, inoculation and fill/finish 
  • mRNA suites with capabilities to handle flammable liquids and BSL-2 classification
  • Dedicated space for custom manufacturing pods, built to spec

Protein - Madison

ALD Madison Aerial_12_CRP-16-9

Our Madison, WI, location provides custom process development, manufacture, and testing of recombinant proteins and enzymes supporting research through clinical applications. Our capabilities range from parallel screening through process development optimization, to scale-up manufacturing 

Early in 2021, we completed a renovation and expansion project that took advantage of an existing $8M purpose-built, bio-manufacturing facility adjacent to our existing space in the University of Wisconsin’s Research and Technology Park. The expansion nearly triples the manufacturing space to provide Research grade material. Late in 2021, we started another expansion project that will add an additional 4,500 square feet of space which is expect to be complete Q4 2022.

In July 2021, our Madison site became ISO 13485 certified.

Research Grade Plasmid DNA - Fargo

ALD Advance A1 RG Expansion-16-9

The production of high-quality plasmid DNA for early-stage research purposes is the bedrock of Aldevron. We are committed to our clients, serving them at any phase of their research but the right start is vital to success, enabling you to take your idea from concept to commercial.  

Our new facility is the result of a wall-to-wall rehab of a 45,000 square-foot building in Fargo, ND. This building serves as an anchor to our second Fargo campus, the Advance Campus, which is flanked by two legacy R&D facilities. The expansion opened in Spring 2021, and nearly triples the manufacturing space supporting the manufacture of pDNA for pre-clinical projects and houses technical operations' process development function. 

Get in Touch with Aldevron

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