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MPI Research - Bioanalytical and Analytical Services

Mattawan, Michigan, 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 expert bioanalytical and analytical services in the following specialized areas:

Small Molecule Clinical Bioanalytical Analysis

There was a time when bioanalytical services were relatively simple, but not especially useful. That time has passed. MPI Research has moved from nonspecific assays to the current discipline that precisely analyzes small molecules, biopharmaceuticals, and their metabolites. Drug development has come to depend upon scientists’ abilities to quantify these substances in biological samples by using cutting-edge technology and processes.

Small Molecule Preclinical Bioanalytical Analysis

When it comes to bioanalytical services, one-stop shopping is more than convenient. It is vital to the integrity of the process and to the value of the results—that is, as long as your partner has integrated the right scientific expertise across its operations. This is especially important at the preclinical level in drug development, where go/no-go decisions need to be made early and confidently. A misstep here means lost time and resources. MPI Research offers unrivaled bioanalytical services, fully integrated with our on-site preclinical research laboratories that expedite results and facilitate collaboration. From method development through sample analysis and reporting, we maintain high-quality standards in a responsive working environment.

As a contract research organization, MPI Research offers immense experience and valuable contributions to our Sponsors. In preclinical bioanalytical analysis, we provide a rich, comprehensive perspective that our Sponsors rely on to accelerate moving their compounds along the drug development pathway.

MPI Research brings superior bioanalytical services to the preclinical realms that are fully intertwined with their discovery and clinical capabilities. Our researchers understand the magnitude of investment required to develop new medicines, so they work hand-in-glove with Sponsors to design effective studies, streamline analysis, employ the latest technology, and deliver accurate data rapidly. We provide quality services that allow our Sponsors to advance new treatments, bringing hope to patients worldwide.

Nonclinical Ligand Binding Assays

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. An experienced, skilled partner in immunology and associated analytical services brings a powerful, competitive advantage to drug developers. MPI Research understands that proper assessments, along with scientific and regulatory expertise, are paramount in advancing your immunochemistry studies.

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MSD Assays
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Ligand Binding Assays
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Ligand Binding Assay Capabilities

  • Customized development and GLP validation of bioanalytical methods for detection and quantification of biologics using ELISA, electrochemiluminescence, and homogenous time-resolved fluorescence methods on Meso Scale Discovery, Gyrolab, and Luminex platforms
  • Immunogenicity testing... Show more »

Ligand Binding Assay Capabilities

  • Customized development and GLP validation of bioanalytical methods for detection and quantification of biologics using ELISA, electrochemiluminescence, and homogenous time-resolved fluorescence methods on Meso Scale Discovery, Gyrolab, and Luminex platforms
  • Immunogenicity testing (screening, confirmatory, and NAb assays)
  • Toxicokinetics and bioinformational statistics
  • Fit-for-puropose (FFP) validation of commercial and custom-built single or multiplexed biomarker immunoassays (Luminex, Meso-Scale Discovery, GyroLab)
  • Experience with assessing systemic exposure of a variety of antibody drug conjugates
  • Kidney damage biomarkers (TIMP-1 and NGAL)
  • Alzheimer’s disease biomarkers (Tau and Aβ42)
  • Considerable experience with biosimilars (Rituxan, Herceptin, Enbrel, Neulasta)

Ligand Binding Assay Platforms

  • GyroLab workstations
  • MSD Sector Imager 6000
  • ELISA plate readers
  • Bioplex 200 (Luminex)
  • PerkinElmer Envision (AlphaLISA™)
  • PerkinElmer Janus automated liquid handlers
  • BioTek Microplate Washer
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Small Molecule Bioanalysis
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Making connections is the heart of the scientific process—testing a hypothesis, analyzing results, and taking the next step. MPI Research makes those connections in the laboratory and with our Sponsors. The answers we seek are of critical importance. In the realm of clinical bioanalytical analysis, we link our expertise across a... Show more »

Making connections is the heart of the scientific process—testing a hypothesis, analyzing results, and taking the next step. MPI Research makes those connections in the laboratory and with our Sponsors. The answers we seek are of critical importance. In the realm of clinical bioanalytical analysis, we link our expertise across a spectrum of disciplines to deliver results that drive decisions and fuel the next stage in drug development.
MPI Research brings together a wealth of experience in bioanalytical analysis of small molecules, oligonucleotides, peptides, monoclonal therapeutic antibodies, enzymes, and proteins. Our analytical skillset includes elements/ metals in urine, tissues, serum, and plasma. We can target iron, potassium, calcium, chromium, lanthanum, titanium, nickel, platinum, imaging agents, and more. A wide range of technological tools are employed— including a proprietary Laboratory Information Management System (LIMS)—with superior analytical services and high-throughput examination to deliver results quickly and precisely.

Service Highlights

  • Bioanalysis of protein therapeutics can be performed using ELISA, homogenous time-resolved fluorescence, electrochemiluminescence (MSD), GyroLab, and Luminex platforms
  • Comprehensive bioanalytical and pharmacokinetic services for first-in-human trials
  • Bioequivalence studies including expedited analysis for first-to-file opportunities with timelines for clinical summary reports in as few as 20 days from drug availability
  • High-throughput analysis using state-of-the-art automation and a proprietary LIMS with advanced data management and publishing capabilities
  • Routine timeline for sample analysis of five-day turnaround for audited data
  • Standard timelines for method development and validation of a new chemical entity of two weeks for small molecules and five weeks for protein therapeutics
  • Targeted method development for small molecules, metals, and biologics by experienced senior scientists
  • Structured, systematic approach that incorporates orthogonal assay designs when appropriate
  • Expertise in bioanalysis across a wide variety of standard and unconventional biomatrices (e.g., ocular, toenail, and muscle)
  • Comprehensive pharmacokinetic (PK)/toxicokinetic (TK) analysis services from lead optimization to clinical
    proof-of-concept
  • Method validation that conforms to regulatory and individualized Sponsor requirements
  • Broad licensing for radio-nuclear and controlled substances
  • Proprietary laboratory information management systems for streamlined sample handling, reliable chain-of- custody, and efficient reporting MPI Research uses the most advanced instrumentation and technology available
  • Liquid chromatography mass spectrometry (LC-MS/MS) (API4000 and 5000) systems equipped with high performance liquid chromatography (HPLC) and ultra-high performance liquid chromatography (UHPLC) capabilities
  • Gas chromatography/flame ionization detector (GC-FID), gas chromatography mass spectrometry (GC-MS), or GC-MS/ MS assays for smaller molecular weight (<150 amu), or volatile compounds such as fatty acid methyl esters (DHA/ EPA) or even neurotransmitters
  • HPLC with ultra violet (UV), fluorescence detection (FLD), refractive index detection (RI), and diode array detection (DAD)

Our current resources include:

  • AB Sciex API 4000 and API 5000 MS/MS systems equipped with high performance liquid chromatography (HPLC) and ultra-high performance liquid chromatography (UHPLC) capabilities
  • Ultra violet (UV) and fluorescence detection HPLC systems
  • ELISA microplate readers
  • MSD Sector Imager 6000
  • Gyros workstations
  • Tomtec and PerkinElmer liquid handling systems for automated sample preparation
  • Tissue sample preparation using Covaris adaptive focused acoustics (AFA) ultrasonic extraction instruments, equipped with cryogenic pulverization of hard tissues
  • Centralized Watson™ LIMS for data management and reporting
  • 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, full weekly and monthly backups

Our capabilities include:

  • Robotic automation for high-throughput sample preparation
  • 24/7 sample receipt management
  • Extensive storage capabilities at -20°C and -80°C
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UPLC
Ultra performance liquid chromatography
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HPLC
High Performance Liquid Chromatography
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LC-MS/MS
Liquid chromatography tandem mass spectrometry
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Bioavailability and Bioequivalence Studies
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Bioequivalence studies including expedited analysis for first-to-file opportunities with timelines for clinical summary reports in as few as 20 days from drug availability

Bioequivalence studies including expedited analysis for first-to-file opportunities with timelines for clinical summary reports in as few as 20 days from drug availability

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Bioanalytical Assays
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Comprehensive bioanalytical and pharmacokinetic services for first-in-human trials

Comprehensive bioanalytical and pharmacokinetic services for first-in-human trials

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GC-MS
Gas Chromatography Coupled Mass Spectrometry
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Gas chromatography/flame ionization detector (GC-FID), gas chromatography mass spectrometry (GC-MS), or GC-MS/ MS assays for smaller molecular weight (<150 amu), or volatile compounds such as fatty acid methyl esters (DHA/ EPA) or even neurotransmitters

Gas chromatography/flame ionization detector (GC-FID), gas chromatography mass spectrometry (GC-MS), or GC-MS/ MS assays for smaller molecular weight (<150 amu), or volatile compounds such as fatty acid methyl esters (DHA/ EPA) or even neurotransmitters

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GC-FID
Gas Chromatography/Flame Ionization Detector
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Gas chromatography/flame ionization detector (GC-FID), gas chromatography mass spectrometry (GC-MS), or GC-MS/ MS assays for smaller molecular weight (<150 amu), or volatile compounds such as fatty acid methyl esters (DHA/ EPA) or even neurotransmitters

Gas chromatography/flame ionization detector (GC-FID), gas chromatography mass spectrometry (GC-MS), or GC-MS/ MS assays for smaller molecular weight (<150 amu), or volatile compounds such as fatty acid methyl esters (DHA/ EPA) or even neurotransmitters

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Product Testing Services
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Biochemistry & Molecular Biology
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Mass Spectrometry
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Protein Services
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Purification Services
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Chromatography
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Pharmacology & Toxicology
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Imaging & Spectroscopy
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Other Mass Spectrometry Methods
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Chemistry and Materials
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Biology
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Liquid Chromatography
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Bioanalysis
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Analytical Chemistry Services
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Liquid Chromatography Coupled Mass Spectrometry Methods
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Product Development, Testing, and Packaging
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Project Management, Consulting, & Support Services
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Protein Quantification
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Experimental Design
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Biomolecular Interaction Analysis
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Spectroscopy
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