Clinical-Bioanalytical-Analysis

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.

Service highlights

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, in collaboration with a local 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