In March 2018, US-based biotechnology company Aldevron began construction of a good manufacturing practice (GMP) compliant plasmid manufacturing facility in Fargo, North Dakota.
Scheduled for completion in the second half of 2018, the facility is expected to be the world’s biggest plasmid DNA manufacturing facility.
Aldevron has invested $30m in the facility, which is expected to double the company’s GMP manufacturing capacity and enable it to meet growing demand for current good manufacturing practice (cGMP) products.
Details of the Aldevron facility in Fargo
Aldevron’s plasmid manufacturing facility will have a total floor space of 70,000ft², including 17,000ft² of modular cleanrooms to be used for cGMP production.
The facility will also include ISO 8 and ISO 7 processing suites for cell banking and fermentation, as well as an EU-compliant Grade A product dispensing zone. The facility’s fermentation scale will range from 10l to 300l single-use systems, with the capacity to expand to 2,000l in the future.
The product-dispensing and cell-banking suites will feature a single-pass airflow, while the production area will feature a unidirectional personnel flow and airlocks. The cleanroom systems will be designed to provide customers with high-quality manufacturing.
The facility will also be equipped with an emergency generator back-up power, automated alarms and environmental monitoring systems.
Products manufactured at the Aldevron facility in Fargo
The facility will provide high-quality plasmid DNA manufacturing services using single-use fermentation (SUF) technology, which minimises the need for costly cleaning validations and reduces the time between GMP production runs.
The plant will produce a variety of plasmid DNA catalogue items, which will be used to carry out research in mammalian cells. It will produce research-grade plasmid DNA, GMP-Source™ plasmid DNA, and GMP plasmid DNA.
Research-grade plasmid DNA is used in research applications in small, mid-size, large and high-throughput production scales. GMP-Source plasmid DNA is used as a subsidiary or critical raw material for manufacturing protein and viral candidates used in clinical trials.
Aldevron provides a range of customised GMP plasmid DNA services, from early research to commercial supply.
Contractors involved in Aldevron’s Fargo facility
US-based cleanroom expert AES Clean Technology was contracted to design and construct the facility.
Marketing commentary on Aldevron
Based in Fargo, North Dakota, Aldevron was initially established as a small laboratory in the North Dakota State University in 1998. It later expanded into a biotechnology firm specialising in the production of nucleic acids, proteins, plasmids, RNA, gene editing enzymes and antibodies.
Aldevron provides clients with critical raw materials and key components used for a wide range of research, pre-clinical, clinical, diagnostic and commercial applications, including gene therapy, gene editing and immunotherapy programmes.
The company’s client base spans from some of the largest pharmaceutical companies to small start-ups. Its Fargo site spans seven acres and includes a 50,000ft² GMP facility.