In late July ATMI LifeSciences completed a two-year, $4.5 million, 4,000 sq. ft. expansion project for its Bloomington, MN, manufacturing facility. The site will serve as the North American hub for the production, marketing, and development of its Integrity™ single-use technologies for biopharmaceutical and other life science applications.
The added capabilities double the company’s worldwide capacity for the fabrication of its Integrity single-use product line of 2-D and 3-D transfer, storage, mixing, and bioreactor vessels, while adding supply chain contingency through a dual-manufacturing capability shared with the existing bioprocess manufacturing plant in Hoegaarden, Belgium, according to Mario Philips, senior vp and GM of ATMI LifeSciences.
The Bloomington site also will continue to host ATMI’s manufacturing operations for high-purity liners and specialty chemical dispense systems for the semiconductor and flat panel display industries.
“We decided to use some of our existing semiconductor business infrastructure to expand our life science capabilities,” explained Philips. “Most semiconductor manufacturing has moved to Asia and we expect that trend to continue. Our vision is that the Bloomington facility will add more life science manufacturing capacity moving forward because biotech’s biggest market is still here in the U.S.
“We have developed this world-class facility in direct response to the growing needs of our North American customers for additional single-use bioprocess vessel manufacturing capacity. Creating a copy-exact of our Belgian facility for change management and supply chain security reasons also helped us to quickly replicate cGMP procedures,” added Doug Neugold, ATMI’s CEO and president.
“With advanced vessel design, 100% integrity testing, and extensive quality controls, we continue to apply our experience in semiconductor manufacturing to our life science business.”
Neugold specifically cited the company’s semiconductor expertise in particle reduction technology, innovation, product quality, and statistical process control as being directly transferable to its biomanufacturing business.
The Bloomington facility additions feature a 2,500 sq. ft. Class 1000 cleanroom with Class 100 work areas. There is also a new demonstration and applications laboratory and a separate product development laboratory.
In addition, the Bloomington expansion is ISO 9001 certified and cGMP compliant, and it extends operating procedures and quality testing practices based on those in place at the Hoegaarden facility, noted Neugold, who pointed out that the Bloomington production area houses advanced custom-film welding equipment for vessel chamber production and the attachment of fitments and tubing.
“There is dedicated space to perform 100% integrity testing of each fully assembled vessel, in addition to bio burden, weld strength, and particle contamination monitoring on a per lot basis,” he said.
As well as providing ultraclean film products and single-use systems and packaging for both the life science and semiconductor/display industries, ATMI LifeSciences also offers its PadReactor™ and Nucleo® bioreactors, range of mixing systems, and media storage and transfer vessels. All of these products are manufactured using the same Integrity TK8 film to minimize validation and integration time and costs, according to Philips.
Citing the needs for flexibility and multiproduct approaches, Philips sees vaccine production and the CMO business as the two key areas of growth for disposable bioprocess systems.