PPD's bioanalytical lab facilities in Middleton, Wis., and Richmond, Va., have a combined total of more than 40 years of experience. They offer bioanalytical lab testing services such as: comprehensive, state-of-the-art assay development, transfer, validation and sample analysis technologies in multiple biological species and matrices as well as metabolite identification using the Q-Tof Micro LC/MS/MS instrument. The labs have expertise in many proven validated methods (Adobe Acrobat file, 258 KB) to quantitatively measure all types of compounds using LC/MS/MS, HPLC and immunochemistry.

Our labs also provide biomarker measurement services that can be designed to meet clients’ needs.

Learn more by viewing our online bioanalytical lab tour or checking out the bioanalytical lab equipment page.

Expert Scientists, Proven Systems

With an average of 17 years at PPD's bioanalytical labs, our executive management team brings experience and longevity. Each member of our laboratory management team has more than 10 years of experience in a contract laboratory environment, and our technical professionals have extensive experience in bioanalytical testing laboratories dedicated to drug development.

The bioanalytical lab scientists at PPD effectively meet clients' requirement for accurate, high-quality results with:

• Efficient analysis of complex analytical assignments
• Advice on procedures to obtain the needed data
• Refined analytical standard operating procedures (SOPs) and laboratory procedures

On-Site Quality Assurance (QA) Department

Our quality assurance (QA) department, a separate unit reporting to the QA vice president, ensures adherence to analytical methods, SOPs and GLP regulatory obligations and guidelines. PPD ensures the accurate, high-quality results sponsors need through:

• Strict compliance with SOPs to meet regulatory standards
• Successful completion of FDA audits (45 in the last 22 years)
• Analytical SOPs and laboratory procedures refined through years of experience

Substantial Capacity in LC/MS/MS

PPD's bioanalytical labs offer substantial capacity and expertise in this highly demanded bioanalysis technique. We have applied LC/MS/MS to compounds that range from small molecules to peptides with measurement in biological fluids and tissues. We utilize the most advanced automated sample cleanup techniques for rapid sample analysis and employ stable isotope internal standards for precise and accurate quantitation.

Variety of Immunochemistry Services

PPD provides comprehensive immunochemistry services for compounds in development with special emphasis on monoclonal antibody drugs, protein drugs, protein drug conjugates and peptides.

We offer GLP-compliant immunoassays in our expanded bioanalytical laboratory using RIA, MSD electrochemiluminescence and ELISA with state-of-the-art detection techniques. Our ability to perform immunogenicity testing for antibodies to immunogenic drugs is complemented by a cell culture lab for conducting bioassays to detect neutralizing antibodies.

Our senior scientists have contributed to the development of accepted industry methods for immunochemistry and are continually developing, validating and transferring industry-leading new methods to the bioanalytical laboratory.