Behind the Innovation
Avantor is entering a new phase of scientific capability and customer support with the launch of a new Biopharma Support Lab facility in North America, adding key quality-control capabilities at its existing 90,000 sq ft manufacturing facility in St. Louis, Missouri: GMP-aligned microbial testing and ICH-compliant stability testing and storage.
This centralized site eliminates logistical hurdles, reduces customer risk, and brings essential testing capabilities significantly closer to many of Avantor’s API and excipient manufacturing sites. “By bringing these capabilities to a single site in North America, we reduce handoffs and global shipping risks, drive faster turnaround times and improve data control,” Dan Frenia, SVP for Quality and Regulatory at Avantor, explained.
A First-of-Its-Kind Microbial Testing Lab
Avantor’s North American microbial testing laboratory offers endotoxin testing, GMP-regulated microbial analyses and environmental monitoring for both raw materials and finished goods.
Previously, these samples were tested predominantly at third-party labs and at Avantor’s Gliwice, Poland, laboratories. “More than 2,000 samples annually will now flow through Avantor’s microbiology team in St. Louis,” Quality Control Manager Melissa Bridgers said.
State-of-the-Art Stability Testing and Storage
Avantor’s stability testing lab includes more than 500 square feet of bench space, four fume hoods, and a full-glass showcase wall to facilitate customer audits. It also includes dedicated areas for sample receipt and storage. The laboratory directly interfaces with six custom-built stability chambers designed to support the rigorous demands of consumer and ICH expectations for regulated stability programs. The chambers accommodate ambient, accelerated, and refrigerated storage conditions, delivering consistent environments that meet applicable regulatory requirements.
“We offer more than 21,000 cubic feet of controlled storage space—sized specifically for high-risk materials with labeled storage conditions, such as APIs and excipients,” Carrie Cupp, site leader for Avantor’s St. Louis footprint, explained. “All Avantor APIs manufactured in North America, including our J.T.Baker® and Reliable Biopharmaceutical® lines, will be run through here for stability testing.”
The accelerated chamber is especially valuable for new product introduction: six months of testing under accelerated conditions (high-heat, high-humidity) supports assigning a 12‑month expiry, speeding time to market and enabling rigorous testing of stability performance.
A Customer-Ready Facility Designed for Transparency
Because regulated testing requires customer audits, the entire space was designed with visibility into the company’s QC processes in mind. The Showcase Lab, with its full glass wall, also highlights the custom lab-building capabilities of VWR® Services, a part of Avantor.
By bringing ICH-compliant chambers and in-house expertise under one roof, Avantor supports improved sampling turnaround times, data integrity, and regulatory compliance while reducing costs and risks for customers.
Learn more about Avantor’s quality and compliance capabilities here.
Learn more about Avantor’s manufacturing capabilities here.
Learn more about VWR Service’s lab design capabilities here.