Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY DESCRIPTION

Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. We strive to meet the business needs of our customers for high quality, cost-effective analytical measurements and services. We work for
a wide range of companies; from smaller virtual companies up through some of the largest companies in both the pharmaceutical and medical device industries. Our services include methods development/validation, raw material testing, stability testing and storage, product release testing, chemical characterization and residual chemical analysis. Pace Analytical Life Sciences operates two laboratories, one located in Oakdale, MN and the other in San German, Puerto Rico. We are FDA registered, DEA registered and ISO/IEC 17025:2005 accredited.

COMPANY BACKGROUND

Date Founded 1996
# of employees 100

Key Personnel

• Steve Vanderboom - CEO
• Greg Kupp - Vice President, COO
• Cynthia Hansen - Director, Quality Assurance

FACILITIES

Pace Analytical Life Sciences operates two cGMP compliant facilities: one located in Oakdale, MN and the other located in San German, PR. Our Oakdale, MN facility is 40,000 square-feet, ISO/IEC 17025:2005 accredited and houses over 75 employees along with a full array of state-of-the-art equipment. Our laboratory
in San German, PR is 12,000 square-feet and houses over 25 employees.

Oakdale, MN Laboratory

San German, PR Laboratory

SERVICES & CAPABILITIES

Pace Analytical Life Sciences provides the following contract analytical testing services to support the pharmaceutical and medical device industries:

ANALYTICAL CHEMISTRY SERVICES: Method Development & Validation, Stability Testing & Storage, Product Release Testing, Raw Material/Compendia Testing (USP/NF, EP, JP), Extractable/Leachable Testing, Mass Spectroscopy Services (LC/MS, LC/MS/MS, GC/MS, ICP/MS) and Aerosol Testing Services.

MICROBIOLOGY SERVICES: Sterile Product Testing (Sterility, Bacterial Endotoxins, Particulate Analysis, Biological Indicators), Non-Sterile Product Testing (Microbial Limits, Antimicrobial Effectiveness Testing, Bioburden Testing), Product Release Testing, Facility Support, Environmental Monitoring, Purified Water and Sterile Water for Injection Testing, Organism Identification (Riboprinter and Biolog Capabilities)

MEDICAL DEVICE SERVICES: Combination Product Testing, Device Testing, Biocompatability Testing (ISO 10993), Physical Testing, Materials Testing, Package Testing, Ethylene Oxide Residual Testing, Extractable/Leachable Testing, Shelf Life and Accelerated Aging Testing