Eurofins BPT expands micro testing services and sites for macro capabilities

Angie Smith, Site Director, Eurofins BioPharma Product Testing Portage

Although the word alludes to little, microbiology, is a large part of bio/pharmaceutical testing and requirements. To serve clients’ growing needs, Eurofins BioPharma Product Testing (EBPT) is continually expanding its comprehensive range of microbiology services and laboratory locations across North America. Sites in the EBPT network that include microbiology laboratories are Lancaster, PA, with both pharmaceutical and medical device microbiology laboratories; Portage, MI; and Toronto, Canada. And most recently with macro micro capabilities in mind, Eurofins acquired Infinity Laboratories. This acquisition added significant microbiology regional coverage and expanded footprint in North America. The locality of the Infinity sites with microbiology capabilities include Petaluma, CA; San Diego, CA; Crown Point, IN; and North Brunswick, NJ.

A recent article in this spring newsletter highlighted the increasing footprint for environmental monitoring (EM) collection and support of facility validations into more regions. Including EBPT Lancaster, PA, in the mid-Atlantic and Northeast, which provides on-site collection services, EBPT ENCO, located in both Cary, NC, and Jacksonville, FL, has established sample collection services and is ready to serve clients throughout the Southeast. Further, our Eurofins site in Portage, MI, can support on-site environmental monitoring collection and testing, providing service for the upper Midwest. With the addition of Infinity Laboratories to EBPT, the locations that perform on-site collection for environmental monitoring and facility validation has doubled. Not only has additional capacity been added to the Midwest and Northeast sites, but now there is microbiology laboratory testing in the West. As these lab sites are integrated into the network, we are excited to offer a comprehensive network of microbiology laboratories and on-site sampling teams across North America.

We are also working to provide Medical Device customers with local options for microbiology testing no matter where their product is developed, manufactured, or sold. These Infinity locations: Petaluma, San Diego, Crown Point, and North Brunswick, include microbiology testing for Medical Devices. The Bio-Pharma E&L St. Louis Infinity site adds a new service for measuring Ethylene Oxide (EO) residuals, which are the remaining traces of ethylene oxide and other byproducts that may be present after a medical device has been sterilized with EO gas. Eurofins Medical Device Testing in Lancaster has expanded its capacity for sterility testing with the addition of a new state-of-the-art clean room facility. The new sterility suite will be used to support sterilization validations, as well as to conduct routine sterility tests and quarterly dose audits.

In addition to compendial microbial limits, bioburden, sterility, and LAL endotoxin testing offered, multiple locations also offer genotypic identification, including the San Diego, Crown Point, Toronto, and Lancaster
sites. The Lancaster site utilizes Unilocus Comparative Sequencing (ULSA), which uses PCR to amplify more than 1,350 base pairs, double strand sequencing, and comparison to our validated, proprietary database: Eurofins Microbial Sequencing Index that includes more than 9,260 valid type strains. The Portage site is in the process of onboarding ULSA for genotypic identification. Another good option at the Lancaster site for bacteria and yeast identification is the MALDI-TOF mass spectrometry that creates a unique proteomic fingerprint of an organism. This fingerprint matches characteristic patterns within the instrument library, which consists of over 11,000 entries that span more than 4,000 species of bacteria and yeasts.

To further expand capabilities and capacity across our network, the Portage facility onboarded a sterility isolator and LAL endotoxin testing in 2024 in support of testing for sterile products. The Lancaster team is planning to launch a new Sievers Eclipse endotoxin system in 2025. EBPT Lancaster will onboard endotoxin testing with rFC, a sensitive synthetic protein cloned from factor C DNA. This allows for a consistent and sustainable source of reagent for the endotoxin test, conserving horseshoe crab populations. Implementing rFC at EBPT Lancaster is the first step in introducing this service offering to the broader EBPT Microbiology laboratory network in the US. We are committed to continue expanding our EBPT and Medical Device network’s range of microbiology services and increasing microbiology testing options to serve clients’ individual needs and make micro advancements with a macro impact.