Aldevron has selected AES Clean Technology, a leader in the design, manufacturing, and construction of modular cleanroom systems, to design modular cleanrooms for Aldevron’s $30 million, 70,000 square-foot manufacturing facility in Fargo, N.D. Cleanroom construction is underway with target completion date of early summer.
“Aldevron’s new facility is built with the AES modular cleanroom technology that delivers speed, cleanliness, quality and repeatable performance,” said Michael Chambers, Aldevron CEO. “Our building will be the world’s largest and most advanced plasmid DNA manufacturing facility. This project is part of our vision to provide clients with unsurpassed scale and quality. The site delivers on our strategy to maintain leadership in plasmid DNA manufacturing from discovery research through commercial production.”
The state-of-the-art facility includes:
- 70,000 square feet of space with 17,000 square feet of modular cleanrooms for cGMP production
- Unidirectional personnel flow and airlocks within the cGMP production area
- Emergency generator backup power for all production and storage areas
- Integrated facility and environmental monitoring with automated alarms
- Single-pass air for product dispensing and cell banking suites
- ISO 8 processing suites with ISO 7 suites for cell banking and fermentation
- Fully EU-compliant Grade A product dispensing area
Henry Hebel, Aldevron COO, added, “Aldevron is pleased to be working with AES, the recognized leader in cleanroom design and construction. Our design includes advanced independent air-handling and modular cleanroom systems to ensure our clients the highest possible quality and compliance. Our GMP capacity will double in the new facility and our fermentation scale will range from 10 L to 300 L single-use systems, with the ability to expand to 2,000 L under the same roof. This capacity and flexibility combined with Aldevron’s 20 years of experience and successful delivery of thousands of lots, including material for the manufacture of commercial products, solidifies our position as the global leader in plasmid DNA production.”
“AES is proud to be designing and building the cleanrooms for Aldevron’s new facility,” said Grant Merrill, AES Director of Project Development. “Our unique set of skills, coupled with our ability to deliver fully customized cleanrooms in an extremely rapid timeframe, will allow Aldevron to serve its growing client base with a reliable supply of cGMP products.”
Aldevron’s facility will be operational in the summer of 2018, with the company now scheduling work throughout 2018 and 2019.