Getting to Know Our St. Paul Site

The Twin Cities, Minneapolis and St. Paul, are collectively known as "Medical Device Alley" due to the concentration of medical device companies and expertise in the area. St. Paul's two locations in Mendota Heights, Minnesota, are part of this industry hub. The St. Paul site primarily focuses on medical device safety testing, including biocompatibility, chemical characterization (extractables/leachables) and toxicological risk assessment -- all critical components in the regulatory requirements for all devices. Medical devices range from basic tools like needles to complex products such as heart valves and tissue-based solutions.

While the primary focus of our St. Paul site is medical device safety testing, they also conduct some testing for the pharmaceutical industry. This includes testing for combination products, drug delivery methods as well as container closure and extractables/leachables testing for single use systems in bioprocessing.

The original facility on Executive Drive was WuXi AppTec’s International headquarters, the space currently houses biocompatibility labs as well as contract manufacturing. Analytical chemistry testing and Regulatory Toxicology/Consulting were added in a separate building in 2011 to meet the demands for these services based on updated international standards.

Currently, the chemistry/consulting group operates out of a state-of-the art analytical chemistry lab on Pilot Knob Road, just a ? mile away from the biocompatibility site, and provides chemical characterization and safety evaluations to Medical Device and Pharma/Biopharma markets. The chemistry team has been recognized by clients and regulatory bodies alike for their ability to identify compounds with their team of experts; “Unknowns are Unacceptable?” is the chemistry teams’ commitment for every extractables/leachables study. The chemistry group will expand to a second laboratory in Munich, Germany, in 2024.

As a result of distinct quality systems and the significant growth experienced at each location, Executive Drive and Pilot Knob Road operate independently on a daily basis. At the helm of the Executive Drive site is Gabe LaBrun, while Sandi Schaible leads the Pilot Knob site.

Meet the Site Employees

We are proud to have a talented team of over 360 employees in St. Paul, spread across both buildings. Among them, more than 250 are highly qualified scientists with degrees or specialties in Chemistry, Biology, Toxicology, or Pathology.?

In addition to our scientific experts, our site remains home to numerous Shared Services staff members. This includes a dedicated team of Sales and Marketing professionals, Finance and Accounting experts, and skilled Information Technology and Human Resources personnel.

Site Certifications

Executive Drive:?

• A2LA Accreditation To ISO/IEC 17025:2017 granted 12 OCT 2021; Certificate # 2785.01 (includes ISO 10993 Parts 10, 12 and 23)
• Food and Drug Administration (FDA) Bioresearch Monitoring Program (BIMO) Active Non-Clinical Laboratory Listing.??

Pilot Knob Road:?

• ISO 17025 certification for extractables and leachables.

To learn more about our quality certificates, please click here.