Clinical Bioanalysis of Large Molecules

Clinical Bioanalysis of Large Molecules Services

Standardized global bioanalytical technology platforms for Ligand-Binding Immunoassays (LBA) are conducted globally by Pharmaron. Capabilities include serological and cell-based assays for large molecule analyses in PK, PD, ADA, NAb, biomarkers and cell-based assay development, validation and sample analysis. These serological and cell-based platforms are supported in-house by full-method development programs and full-spectrum assay transfer capabilities, including feasibility assessments targeting the specifics of clinical bioanalysis projects for PK/PD/ADA assays, etc. Upon completion of assay development, fully compliant method validation is performed per FDA/EMA/NMPA guidance. Clinical sample analysis is then executed in support of the clinical studies. In addition to LBA assays, other tech-based assay platforms have also been established to support various bioanalytical needs in clinical studies.

  • Assay development, transferred and kit-based assay optimization to support bioanalysis of therapeutic biologics in the clinical development phase
  • Assay development, transferred and kit-based assay optimization for the analysis of ADA, ADCC, CDC and ADCP, TDAR and NAb, etc.
  • Assay development, assay transferred and kit-based assay optimization for analysis of biomarkers of interest
Mesoscale discovery is employed to study the mode of action after performing cell-based functional assays.

Analytical Platforms

  • HPLC
  • LC/MS, hybrid-immunoaffinity LC-MS
  • ELISA, HELISA
  • MSD
  • Gyrolab
  • Flow cytometry
  • Luminex
  • qPCR
  • ddPCR
  • Immunohistochemistry
A scientist wearing protective gloves and goggles closely examines a vial, emphasizing precision in clinical bioanalysis of large molecules.

Analytes

  • Recombinant proteins
  • Peptides
  • Antibodies
  • Vaccines
  • Biomarkers, including DNA, mRNA, small molecule-based
QuantStudio 7 Flex qPCR machine in use for clinical bioanalysis of large molecules, with data processing visible on a computer in the background.

Areas of Applications

  • Quantitative PK/PD studies
  • PK/PD correlation
  • Immunophenotyping analysis
  • Immunogenicity analysis
  • Biomarker assessment
  • Statistical analysis (cut-point and positive control determination for ADA)
  • Critical reagent production, conjugation, qualification, management

Learn more about Pharmaron’s large molecule bioanalytical services

        A slide titled "Service Overview" showcases Pharmaron's Large Molecule Bioanalytical Services, detailing various assays and techniques integral to bioanalytical development. A "Download Below" button sits on the right, with the Pharmaron logo at the bottom right corner.