The depth and breadth of the bioanalytical/analytical sciences offered at MPI Research in support of all phases of drug discovery and development studies is unsurpassed in the industry. We provide a full scope of bioanalytical and analytical services to the pharmaceutical (human and animal health), biotech, chemical, and related industries and offer our Sponsors the added advantage of competence under both GLP and cGMP regulatory drivers.

The MPI Research analytical staff of over 160 dedicated and talented professionals performs their services in 60,000 ft² of customized laboratory space using the most advanced instrumentation and technology available, including 40 LC-MS/MS systems.

Adopting each Sponsor’s priorities as our own, the analytical services team at MPI Research believes that when our Sponsors succeed, we succeed.

Services/Capabilities

Bioanalysis

• Method development via a structured and systematic approach
• Method validation that conforms to regulatory and customized Sponsor requirements
• Bioanalytical chemistry via LC-MS/MS or immunoassays
• Preclinical and clinical sample analysis
• Elemental analysis (HR ICP-MS, ICP-MS, AA, CHN)
• Metabolic isolation, identification, and structural elucidation
• Radiochemical determinations
• Rapid method development and analysis in support of non-GLP pilot PK studies

Formulation Analysis

• Method development and validation
• Full interlaboratory transfer
• Dose formulation analysis including stability, homogeneity, and concentration
• Experience with solution, suspension, and diet matrices

CMC Testing

• Method development, validation, and transfer
• Chromatographic analysis (HPLC, GC, IC, GC-MS, LC-MS)
• Identification of impurities and degradation products
• Reference standard characterization
• Stability and release testing
• Stability storage

Equipment
MPI Research has 40 LC-MS/MS Systems available, in addition to a wide array of Liquid Chromatography (LC) Systems, Gas Chromatography (GC) Systems, Elemental Analysis Systems, Spectrophotometers, ELISA and electrochemiluminescence readers, and many other types of analytical hardware. Contact us for a complete listing of available equipment.

Technology
ExyLIMS™, our proprietary, 21 CFR Part 11-compliant laboratory information management system, is designed to proactively ensure regulatory compliance through several processes: instrument qualification, training records, and document management. The system maintains inventory of all test articles and samples; data is captured in ExyLIMS via printable PDF files and reports can be written against the database in most Sponsor-specified formats.

Watson™ Bioanalytical LIMS, another 21 CFR Part 11-compliant laboratory information management system, is also utilized. This LIMs system is used for sample tracking, data capture and quantitation, and generation of customized data reports. The Watson LIMS also provides rapid estimation of PK/TK parameters such as Cmax, AUC and T ½. For full PK/TK modeling MPI Research uses WinNonlin.

Quality Assurance
The Quality Assurance staff at MPI Research works in cooperation with study teams to ensure that facilities, equipment, methods, practices, records, and controls are in compliance with applicable regulations, study protocols, and standard operating procedures. Regular and frequent audits are conducted to assure seamless GLP and cGMP compliance.

Service and Communication
We are committed to providing personalized service and data of the highest quality, and the MPI Research scientist (Study Director) assigned to your project will oversee all of its’ phases and will lead a team that will work together on your behalf. This project team will be hand-selected based on the scope and complexity of the study.

For more detailed information about the analytical services offered by MPI Research, please contact Analytical@mpiresearch.com. You can also call 269.668.3336, Ext. 4129.

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