USP Acquires Stratix Labs, Enhancing Its Microbiology Portfolio With Innovative Technology

ROCKVILLE, Md, Oct. 21, 2024 /PRNewswire/ -- Today, the U.S. Pharmacopeia (USP) announced the acquisition of Stratix Labs, a microbiology technology company based in Saint Paul, MN. This acquisition marks a significant milestone for USP's portfolio, as it will expand its microbiological solutions supporting microbial contamination control with broad applications across pharmaceuticals, including biologics and compounded medications.

Microbiological quality control is essential to ensure fundamental contamination control measures are in place during pharmaceutical production and preparation. Image Credit: © JR-50 - stock.adobe.com

Microbiological quality control is essential to ensure fundamental contamination control measures are in place during pharmaceutical production and preparation. Increased demand and expedited timelines require the industry to identify and implement new approaches to quality control throughout the drug production process, particularly for sterile products. By acquiring Stratix Labs, USP will be better equipped to help drug manufacturers, developers, and compounding entities address industry gaps in microbial contamination control strategies, mitigating the risk of contaminated products reaching patients.

"This is an exciting moment for USP as we continue to develop and deliver the latest standards and solutions to meet the needs of the industry today and help ensure quality at every stage of development, manufacturing and delivery in pharmaceutical manufacturing and compounding settings," said Fouad Atouf, PhD, senior vice president, Global Biologics for USP. "Through the acquisition of Stratix Labs, USP has reinforced its commitment to a new era of innovation in quality control while building on its legacy of providing the latest science-based quality standards and solutions for pharmaceutical manufacturers."

With this acquisition, USP is expanding its solutions to reduce microbial contamination risks, giving customers increased access to the latest microbiological quality control testing materials to complement the organization's portfolio of documentary standards. Stratix Labs' innovative microbial preservation technology, which powers its products, will have broad applications across industries relevant to USP, such as compounded medicines and the pharmaceutical/biopharmaceutical space.

Mark Mulvahill, co-founder and chief executive officer of Stratix Labs, said of the acquisition, "Today's acquisition recognizes Stratix Labs' leadership in microbiological quality control and reinforces the value of the technology we have spent years developing."

Josh Erickson, co-founder, president, and chief technology officer, also added, "Joining USP will help bring our innovative products to new markets and enhance our ability to deliver cutting-edge solutions to USP's customers, including drug manufacturers and developers, as well as compounding entities. We look forward to leveraging our technology to expand our product solutions into a suite of new USP reference materials that will serve the industry for years to come."

The expansion of USP's offerings to include innovative, reproducible, and convenient materials for microbiological quality control provides customers with a comprehensive set of solutions to complement USP's current portfolio of documentary and reference standards, helping ensure safe, quality medicines reach patients faster.

"Stratix Labs' products for microbiological quality control tools, combined with existing USP compendial standards and expertise, will facilitate the implementation of microbial contamination control, helping to increase regulatory confidence and ensure the safety and quality of drug products," added Ronald T. Piervincenzi, PhD, USP's chief executive officer.

As part of the acquisition, USP will offer through the Stratix Labs storefront Enverify™, an innovative solution to a long-standing industry wide gap for demonstrating competency in surface testing technique and recovery.

USP, as it has for more than 200 years, continues to evaluate new and evolving technologies to ensure our compendium delivers solutions that help ensure the quality and safety of pharmaceutical products.

To learn more about USP's new microbiological quality solutions, visit: http://www.usp.org/microbiology.

USP Acquisition of Stratix Labs: Frequently Asked Questions

Why did USP acquire Stratix Labs?

The acquisition of Stratix Labs and their innovative microbial preservation technology-which powers their products, including Enverify™, ReadyNowM and Instant lnoculatorM-combined with US P's legacy of providing the pharmaceutical industry with standards and solutions, furthers USP's commitment to being the industry leader in science-based standards and methods that help ensure quality and safety during the manufacturing, development, and preparation of pharmaceutical products.

Why Is USP investing in microbiology?

The acquisition of Stratix Labs reflects USP's understanding of the important role microbial contamination control plays in helping to ensure product safety and quality in the pharmaceutical/biopharmaceutical industry and beyond.
Stratix Labs' innovative microbial preservation technology, which powers its suite of materials, will have broad applications across industries relevant to USP, such as compounded medicines and the
pharmaceutical/biopharmaceutical space.

Products like Enverify, a first-in-class testing tool, provide access for industry stakeholders, including those at small- to middle- sized drug developers, manufacturers, and com pounders to qualify their own sampling methods and demonstrate the competency of their personnel - increasing access to quality products free from microbial contamination.
In addition, ReadyNow is an innovative platform of pre-inoculated test articles for qualifying disinfectants and antiseptics in pharmaceutical manufacturing that enhance efficiency and reliability for critical contamination control processes.
Finally, Instant lnoculator uses this preservation technology to provide quantitative microbial reference strains for use as quality controls for a wide variety of microbiological tests and applications.

How will this enhance USP's offerings?

With the agility and flexibility of a smaller, science-focused company and the experience and global scale of an independent, scientific standards-setting organization, this integration will help USP enhance its suite of microbiology offerings to support contamination control strategies and biosafety testing, delivering on its mission to support quality and safety at every stage of product development.

What does the acquisition mean for the future of USP?

Stratix Labs’ products for microbiological quality control, combined with existing USP compendial standards and expertise, will help facilitate microbiological testing and simplify the process for manufacturers and developers to qualify these methods and enable them to test for microbial contaminants. Ultimately, it will help them to increase regulatory confidence and ensure the safety and quality of drug products.

Stratix Labs’ core microbial preservation technologies should also lead to a host of other innovative products that support microbiological testing well into the future.

When will these products be available?

Information on ordering Enverify™, ReadyNow™ and Instant Inoculator™ is now available via Stratix Labs’ website.

About USP:
USP is an independent scientific non-profit organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. This includes actively collaborating with academic research centers, industry, and regulators to help with the adoption and implementation of advanced manufacturing technologies. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. For more information, visit: www.usp.org.

Media Contact:
mediarelations@usp.org

SOURCE US Pharmacopeia