Stratix Labs FAQs

Why did USP acquire Stratix Labs?

The acquisition of Stratix Labs and their innovative microbial preservation technology—which powers their products, including Enverify™, ReadyNow™ and Instant Inoculator™—combined with USP’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 compounders 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 Inoculator™ 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.