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MPI - Preclinical Services

Mattawan, MI, US

MPI Research is a full drug development contract research organization with the world’s largest single-site preclinical facility. Our Sponsors benefit from our full suite of preclinical research services.

Our Sponsors value our collaborative culture that is uniformly committed to helping them move their compounds from bench to regulatory filing with accuracy, quality, and speed. Our experienced staff is flexible in adapting to changes and quickly responds to challenges as they arise.

MPI Research insists on the highest quality professional standards across all services and at all levels, and is in full compliance with international, federal, and state regulatory agencies. We are

  • Fully AAALAC accredited
  • In compliance with all FDA, EPA, EMEA, OECD, ICH, and JMHW guidances and regulations
  • Dedicated to quality performance and continuous improvement, with registered QA professionals (RQAP-GLP) and on-staff... Show more »

MPI Research is a full drug development contract research organization with the world’s largest single-site preclinical facility. Our Sponsors benefit from our full suite of preclinical research services.

Our Sponsors value our collaborative culture that is uniformly committed to helping them move their compounds from bench to regulatory filing with accuracy, quality, and speed. Our experienced staff is flexible in adapting to changes and quickly responds to challenges as they arise.

MPI Research insists on the highest quality professional standards across all services and at all levels, and is in full compliance with international, federal, and state regulatory agencies. We are

  • Fully AAALAC accredited
  • In compliance with all FDA, EPA, EMEA, OECD, ICH, and JMHW guidances and regulations
  • Dedicated to quality performance and continuous improvement, with registered QA professionals (RQAP-GLP) and on-staff Lean Six Sigma Blackbelts
  • Continually conducting inspections of GLP and Bioequivalence studies and reports
  • Committed to conducting ongoing operational and subcontractor audits

MPI Research offers preclinical services in the following areas:

Anatomic and Clinical Pathology

Pathology lies at the heart of life science research and development, providing information on test article-related effects and interpreting the biologic and toxicologic significance of these effects. An intricate and complicated science, doing it well requires time, resources, and talented personnel. The accurate assessment of pathology endpoints in animal models, used to determine the safety profile of a drug or device in its intended population, is a critical phase in the development of a potentially life-saving drug or device.

Clinical Bioanalytical Analysis for Biologics

The human body is remarkable in its ability to wage war against a host of diseases and infections. Understanding the immune system’s arsenal provides valuable knowledge that drives some of the latest innovations in drug therapy, especially in biologically derived medicines and vaccines. MPI Research understands that proper assessments, along with scientific and regulatory expertise, are paramount in advancing your biologic studies.

MPI Research has developed and validated more than 300 bioanalytical methods for biologics over the past five years. These methods have been validated for the analysis of drugs in plasma, serum, urine or CSF, which include TK/PK, immunogenicity, Nab, and biomarker assays. All methods were validated in accordance with FDA and European Medicines Agency (EMA) guidelines for Bioanalytical Method Validation.

MPI Research offers customized development and validation of bioanalytical methods for the detection and quantification of biologics with a wide range of molecule types, including monoclonal therapeutic antibodies, enzymes, proteins, peptides, and oligonucleotides.

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MPI - Preclinical Services has not listed any services.

ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
Price on request
  • Validated WinNonlin® software
  • Experienced pharmacokineticists
  • Fast interim analysis and interpretation
  • Successful regulatory filing history
  • Production of PK section of clinical study reports
  • Validated WinNonlin® software
  • Experienced pharmacokineticists
  • Fast interim analysis and interpretation
  • Successful regulatory filing history
  • Production of PK section of clinical study reports
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Imaging & Spectroscopy
Price on request

Imaging modalities:

  • PET
  • fMRI
  • X-Ray
  • OCT
  • Dexa
  • Other

Imaging modalities:

  • PET
  • fMRI
  • X-Ray
  • OCT
  • Dexa
  • Other
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Biomarker Discovery
Price on request
  • Genotyped volunteers
  • Archived DNA/rapid genotyping services
  • Specialized biomarker sample preparation
  • Genotyped volunteers
  • Archived DNA/rapid genotyping services
  • Specialized biomarker sample preparation
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Clinical Sample Acquisition
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Genomic DNA Extraction
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Biomarker Clinical Validation
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Bioanalytical Assays
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Bioanalysis of protein therapeutics can be performed using

  • Enzyme-linked immunosorbent assay (ELISA)
  • Homogenous time-resolved fluorescence
  • Electrochemiluminescence (MSD)
  • GyroLab
  • Bead-based (e.g., Luminex) platforms

Speed and Capacity

MPI Research offers comprehensive bioanalytical and pharmacokinetic... Show more »

Bioanalysis of protein therapeutics can be performed using

  • Enzyme-linked immunosorbent assay (ELISA)
  • Homogenous time-resolved fluorescence
  • Electrochemiluminescence (MSD)
  • GyroLab
  • Bead-based (e.g., Luminex) platforms

Speed and Capacity

MPI Research offers comprehensive bioanalytical and pharmacokinetic services for Phase I first-in-human trials, as well as biosimilar programs. Specifically, with our clinic, MPI Research can provide timelines for clinical summary reports in as few as 25 days from critical reagent availability. Our standard timeline for method development and validation of a protein therapeutic is five weeks. Our routine timeline for sample analysis is five days for audited data.

The critical components to achieve these milestones are streamlined workflow processes with a comprehensive training program and a proprietary LIMS with advanced data management and publishing capabilities.

Current Resources

  • ELISA miroplate readers
  • Meso Scale Discovery (MSD) Sector Imager 6000
  • Gyros workstations
  • Bioplex 200 (Luminex) platform
  • PerkinElmer liquid handling systems for automated sample preparation
  • Tissue sample preparation using Covaris AFA ultrasonic extraction instruments, equipped with cryogenic pulverization of hard tissues
  • Thermo Watson™ LIMS system for data management and reporting
  • Proprietary ExyLIMS system for sample and data management
  • Central security alarm monitoring system with 24-hour card-controlled facility access
  • On-site emergency power backup for all sample storage freezers (-20°C, -70°C)
  • Freezer temperature monitoring with remote notification capability
  • AC power failure monitoring systems with immediate notification capability
  • Incremental nightly data backups, as well as full weekly and monthly backups
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Anatomic Pathology
Price on request

A high-quality anatomic pathology evaluation and reporting are some of the most critical components in the assessment of your compound, device, or combination product. The MPI Research pathology team includes one of the world’s largest collections of experienced, board-certified toxicologic pathologists working within a single... Show more »

A high-quality anatomic pathology evaluation and reporting are some of the most critical components in the assessment of your compound, device, or combination product. The MPI Research pathology team includes one of the world’s largest collections of experienced, board-certified toxicologic pathologists working within a single site preclinical CRO. Our expert anatomic pathologists understand the significance of their roles and have extensive knowledge on a wide variety of compounds, animal models, and study designs—offering you peace of mind that the evaluation of your compound is in the right hands. As part of our commitment to high-quality pathology data for our Sponsors, we have been long-time advocates of pathology peer review.

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Animal Necropsy Services
Price on request
  • On-site necropsy supervision by a veterinary pathologist
  • High-capacity, multi-species gross pathology facility with dedicated individual small and large animal workstations
  • Routine and specialized procedures, including
    • Whole-body and upper body perfusions
    • Perilymphatic perfusions of inner ear for ototoxicity... Show more »
  • On-site necropsy supervision by a veterinary pathologist
  • High-capacity, multi-species gross pathology facility with dedicated individual small and large animal workstations
  • Routine and specialized procedures, including
    • Whole-body and upper body perfusions
    • Perilymphatic perfusions of inner ear for ototoxicity studies
    • Harvesting and processing of vascular and coronary stents
  • Specialized digital imaging equipment
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Tissue Preparation
Price on request

Paraffin and frozen tissue processing and slide preparation for routine, specialized, and diagnostic microscopic examination

Paraffin and frozen tissue processing and slide preparation for routine, specialized, and diagnostic microscopic examination

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Immunohistochemistry (IHC)
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Immunofluorescence
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Special Slide Staining
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Bone Marrow Smear
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Animal Blood Gas Analysis
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Biomarker Analysis
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Urinalysis
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Coagulation Profile
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Clinical Cardiac Safety and QT Studies
Price on request
  • 24 beds on digital cardiac telemetry
  • Thorough QTc
  • Holter monitoring
  • Multiple ECG providers for ECG over-read services
  • 24 beds on digital cardiac telemetry
  • Thorough QTc
  • Holter monitoring
  • Multiple ECG providers for ECG over-read services
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Bioavailability Studies
Price on request

Bioavailability/ Bioequivalence (BA/BE)
– Absolute and relative
– Pilot and pivotal

Bioavailability/ Bioequivalence (BA/BE)
– Absolute and relative
– Pilot and pivotal

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Cytopathology
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Protein Services
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Clinical Hematology
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Immunostaining
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Protein Expression Visualization
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Veterinary Laboratory Services
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Clinical Trials, Consulting, and Management
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Clinical Sample Services
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Veterinary Research & Diagnostic Services
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Biomarkers
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Nucleic Acid Services
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Discovery Pathology
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Biochemistry & Molecular Biology
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Histological Staining
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Biology
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Pharmacology & Toxicology
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Tissue Processing
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Clinical Chemistry
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DNA
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Biospecimens
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Clinical Research
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Clinical Laboratory Services
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Cells and Tissues
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DNA Extraction and Purification
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Bioanalysis
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Clinical and Anatomic Pathology
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