The new drug development process not only needs time, patience, money, and expertise but also, most importantly, the appropriate authority's approval before its commercial manufacturing. The drug has to undergo preclinical and clinical trials before it can prove its suitability as a therapeutic. Luminex Assay is one of the essential techniques in preclinical and clinical drug R&D.

Luminex Assay

The Bioplex assay is a multiplex immunoassay system that uses beads coated with different analytes on a microplate surface. The assay uses Luminex xMap (Multi-Analyte Profiling) technology. The beads or microspheres have different color codes due to the beads' internal labeling with varying combinations of two fluorophores, one in the red wavelength region and second in the far red. These beads can take couples with proteins like antibodies, small ligands, nucleic acids, etc. These are specific to the target analyte.

Luminex assay in Preclinical drug R & D

Preclinical studies aim to provide information about a new drug's efficacy and safety before its testing in humans. Some do it in vivo and in vitro studies. The preclinical trial involves pharmacodynamics, pharmacokinetics, and toxicology studies.

  • Pharmacodynamics studies:
  • Pharmacodynamics study is the study of the effect of drugs on the body and the dose-response. The Luminex assay can be of great help in this as it can study the impact of different concentrations of a drug on a cell or tissue in-vitro, all in a single go. It reduces the number of experiments and, hence, the cost and time for this drug's development study.

  • Pharmacokinetics studies
  • Pharmacokinetics study is the study of the effect of the biological system on the drug. The absorption of the drug, its distribution, metabolism, and excretion (ADME) decides its bioavailability at the target site. The Luminex assay can study ADME and effect of cellular proteins and other compounds on the analyte quickly, saving money and efforts.

  • Toxicology studies
  • Toxicology studies determine the safety of the drug for testing in human volunteers. It is useful in deciding the safe and most suitable starting dose of medicine for clinical trials. The use of Luminex assay to check the drug's toxicity in varying concentrations and formulations makes the whole study fast and easy. Time is a significant factor in any drug development process.

    Luminex assay in Clinical drug R & D

    Clinical trials involve the study of the effect of the drug on human volunteers. There are four phases in clinical research. The phase 1 involves a few healthy individuals, while the fourth phase involves real patients. The information about the drug's effect on the fit and the patient volunteers gives an idea about the drug's suitability for human use. The Luminex assay can help speed up the process and get the most accurate results at each stage.

    At the time of drug development, the pharma company had 5,000 compounds. After preclinical trials, it reduces to 250, and after clinical trials, just one remains. Luminex assay makes this entire preclinical and clinical drug research and development process very fast and accurate.

    Author's Bio: 

    Research & Development professional.