Nonclinical Ligand Binding Assays

///Nonclinical Ligand Binding Assays
Nonclinical Ligand Binding Assays 2017-07-04T10:25:15+00:00

2495-gyros

Meeting the Challenges of Biosimilars
Today’s pharmaceutical business is said to be experiencing the “age of biologics” – and that age is reaching an interesting period. As the global biologics market expands dramatically, the industry is facing a substantial patent cliff through the rest of this decade, with nearly $67 billion worth of patents due to expire by 2020.

BLOG

Biopharmaceuticals, vaccines, and cell-based therapies hold enormous promise for life-changing medicines. Assessing their potential requires advanced techniques, special expertise, and personalized services.

Along with our scientific and regulatory expertise in immunology, MPI Research offers customized preclinical assessment for immunomodulatory, biologically derived substances. With dedicated resources, and fully staffed laboratory and resources, we can provide all aspects of preclinical discovery and development. We can conduct specialized in vivo and in vitro immunologic characterization analyses of drug candidates associated with autoimmune diseases, inflammation, and cell-based and vaccine-based technologies.

MPI Research Provides

  • Customized development and validation of regulated bioanalytical methods for detection and quantification of biologics using ELISA, electrochemiluminescence, and fluorescence-based methods on standard spectrophotometer, Meso Scale Discovery, Gyrolab, and Luminex platforms
  • Four tier immunogenicity assay development and testing (screening, confirmatory, titration and NAb assays)
  • Toxicokinetics and bioinformational statistics
  • Program-level support of your bioanalytical needs from drug discovery through early development
  • Fit-for-purpose (FFP) validation of commercial and custom-built single or multiplexed biomarker immunoassays (Luminex, Meso-Scale Discovery, GyroLab)
  • Rapid turnaround on FFP quantitative and immunogenicity assay development and analysis to support candidate selection and your drug discovery needs

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)
  • Extensive experience with monoclonal antibody analysis including common biosimilars (Rituxan, Herceptin, Enbrel, Neulasta)
  • Fully integrated LIMS to track sample, drug, equipment, and material storage and maintenance
  • Watson™ LIMS™ for rapid data analysis and reporting

Ligand Binding Assay Platforms

  • Gyrolab workstations
  • MSD Sector Imager 6000
  • ELISA plate readers
  • Bioplex 200 (Luminex)
  • PerkinElmer Envision (AlphaLISA™)
  • PerkinElmer Janus automated liquid handlers
  • Tomtec Quadra automated liquid handlers
  • BioTek microplate washer