Bioanalytical Laboratory Services

Obtain accurate, high-quality results with PPD’s complete bioanalytical laboratory services. Our advanced state-of-the-art facilities in Middleton, Wis., and Richmond, Va., provide method transfer, development, validation and analysis of preclinical and clinical biological samples in a good laboratory practice (GLP)-compliant setting.

Learn more about our bioanalytical laboratory services by viewing our online tour.

Advanced Laboratories for Bioanalytical Services
With a combined total of more than 40 years of continuous operations at our two laboratories, PPD is a leading provider of bioanalytical services. Our proven laboratory systems deliver accurate, high-quality results in compliance with GLP standards.

Services and resources include:

• Comprehensive, state-of-the-art assay development, transfer, validation and sample analysis technologies in multiple biological species and matrices
• Metabolite identification using Q-Tof Micro LC/MS/MS instrument
• 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

State-of-the-Art Equipment

• PE Sciex API 5000, 4000 and 3000 LC/MS/MS instruments
• Hamilton MicroLab Starlet automatic pipetting workstation
• Micromass Quattro Micro and Q-Tof Micro LC/MS/MS instruments
• Tecan Genesis Logistic robotic sample preparation workstations
• TOMTEC Quadra 96 robotic sample preparation systems
• Waters Acquity UPLC systems
• Cohesive TX-2 Multiplexing systems
• MSD electrochemilluminescence plate readers
• Biacore 3000 analyzers

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

The scientists at PPD effectively meet your requirement for accurate, high-quality results with:

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

High Standard of Excellence
PPD’s rigorous training program for technical professionals exceeds GLP guidelines. New employees receive extensive “hands-on” instruction and participate in an apprenticeship program led by our experienced chemists. Full-time specialists in LC/MS/MS ensure instrument operators are trained and knowledgeable in the use of equipment. Our staff frequently updates their skills by attending relevant seminars and training on new analytical methods, technologies and regulatory guidelines.

Quality Assurance (QA)
Our on-site 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

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.

Immunochemistry
PPD provides comprehensive immunochemistry services for compounds in development with special emphasis on:

• Monoclonal antibody drugs
• Protein drugs
• Protein drug conjugates
• Peptides

We offer GLP-compliant immunoassays in our newly expanded 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 laboratory.