ATMI Expands Bloomington, Minnesota Manufacturing Facility
ATMI Inc. has established a North American hub for the production, marketing, and development of its single-use technologies for biopharmaceutical and other life sciences applications by expanding its Bloomington, MN manufacturing facility.
ATMI, Inc. has established a North American hub for the production, marketing, and development of its single-use technologies for biopharmaceutical and other life sciences applications by expanding its Bloomington, MN manufacturing facility. The North American site was launched at an official ribbon-cutting ceremony on July 28, 2010.
The added capabilities double ATMI's worldwide capacity for ATMI LifeSciences' Integrity 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 existing manufacturing plant in Hoegaarden, Belgium.
"Creating a copy-exact of our Belgian facility for change management and supply chain security reasons also helped us to quickly replicate cGMP procedures," said ATMI CEO and President Doug Neugold.
Featuring a 2,500 sq. ft. Class 1000 cleanroom with Class 100 work areas, the additions also include a new demonstration and applications laboratory and a separate product development laboratory. The production area has a dedicated space to perform 100% integrity testing of each fully assembled vessel, including bioburden, weld strength, and particle contamination monitoring.
"Increasing our manufacturing footprint addresses the rapidly increasing demands of the biopharmaceutical marketplace for single-use vessels applications in the field of storage, mixing and bioreactors," said Mario Philips, senior vice president and general manager of ATMI LifeSciences.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
