Breakthrough Campus

Breakthrough Campus - Fargo, North Dakota

cGMP and GMP-Source® Production of DNA, RNA and Protein
265,000 square feet of new, purpose-built construction

Aldevron’s Breakthrough Campus serves as HQ and as one of the world’s largest cGMP plasmid DNA manufacturing facilities. Breakthrough has been purpose built with the latest innovations and state-of-the-art equipment to produce DNA, mRNA and protein. We serve thousands of clients, and each project is supported by an expert team delivering unmatched quality of product and experience – all backed by our strategically focused operations pathway ensuring efficiency along with scalability, to deliver the critical raw materials you need to accelerate your path to the clinic.

Purpose

Aldevron headquarters
Manufacturing
Quality and regulatory
Ultra low temperature freezer storage and distribution
Administration

Capabilities

cGMP and GMP-Source® manufacturing of plasmid DNA (supercoiled and linear)
cGMP and GMP-Source manufacturing of NanoplasmidTM
cGMP manufacturing of mRNA
cGMP manufacturing of protein

Fast Facts (as of the end of 2022)

More than 4,800 lots of GMP-Source® & cGMP DNA produced
- Supporting more than 1,000 advanced therapeutic companies worldwide
- Part of nearly 1,100 global clinical trials
More than 250 mRNA batches

Key Factor

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)
FDA Establishment Identifier 3015047170

cGMP Manufacturing

32 production suites that are state-of-the-art modular cleanrooms
- Advanced independent air handling systems for cell banking, inoculation, and fill/finish
- Designated client-specific and newly established mRNA production and fill/finish suites with capabilities to handle flammable liquids and BSL-2 classification
- Shaker flask through multiple 30 L and 300 L single use microbial fermenters
- 100% single-use consumables utilized for maximum efficiency
- Multi-product capability
Dedicated training lab