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
GMP-Source® Manufacturing
11 production suites
ISO7 classified dispensing suite
pDNA focused – supercoiled and linear
Shaker flask, WAVE, and 30/300L scales
Stand alone cell bank qualification/yield test lab
