Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster testing results to clients. Alcami invested in the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.
“Our modern rapid sterility solution prominently positions Alcami on the frontline of contract laboratory services and aligns with our strategy to help reduce our customers’ project timelines, from concept through commercialization,” said Alcami Chief Commercial Officer Chad Telgenhof. “Few of our competitors offer rapid sterility capabilities, and even fewer use ATP-bioluminescence technology. We are pleased to introduce rapid sterility as an ideal way to meet our clients’ tight timelines, and reduce or eliminate the need to pay rush fees for sterility tests.”
Rapid sterility is an alternative test method to the traditional United States Pharmacopeia (USP) General Chapter <71> sterility test that allows for shorter incubation periods and faster results to clients. Typical sterility tests require 14 days of incubation and use analyst observations to generate results, whereas rapid sterility tests need only five days of incubation, a 64% reduction in processing time. Rapid sterility is scientifically demonstrated to have comparable recovery to the harmonized USP <71> reference method. Like the reference method, microorganisms detected using the Milliflex Rapid System can later be identified to the species level. The technology also incorporates more sophisticated, computer-generated results, which eliminate observation bias.
While the new Milliflex Rapid System is housed in Alcami’s Wilmington, North Carolina advanced analytical testing technology center, its capabilities are expected to generate efficiencies across the organization, including faster batch releases from the company’s Charleston, South Carolina clinical and commercial scale sterile manufacturing facility.
“Faster release of drug product is extremely valuable to our clients, especially in cases of market shortage products,” said Telgenhof. “We remain committed to helping our clients maintain uninterrupted supplies of their life-saving medicines for the patients around the world who rely on them.”