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Preclinical Bioanalysis of Large Molecules

Preclinical Bioanalysis of Large Molecules Services

The preclinical bioanalysis of large molecules is focused on the analytical needs supporting IND-enabling studies for a large molecule-based therapeutic product. Pharmaron’s bioanalysis teams perform studies (PK, TK, immunogenicity, immune response and biomarker analysis) in GLP-compliant laboratories that meet the regulatory requirements for an IND submission. Bioanalytical methods are developed and/or validated fully, followed by sample analysis and data processing and reporting.  The tech team has been supported extensively by in-house QA and RA teams. Pharmaron’s laboratories have been inspected by FDA, OECD and NMPA agencies successfully since inception.

  • Assay development, transferred and kit-based assay optimization to support the bioanalysis of therapeutic biologics for programs in a preclinical 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

Capabilities

Discovery Bioanalysis of Large Molecules
Preclinical Bioanalysis of Large Molecules
Clinical Bioanalysis of Large Molecules
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Analytical Platforms

  • MSD
  • ELISA
  • HELISA
  • FACS
  • Luminex
  • qPCR
  • ddPCR
  • HPLC
  • LC/MS, imaging-based methods including immunohistochemistry, liquid-handling automation station
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Analytes

  • Recombinant proteins, peptides
  • Antibodies, e.g. mAbs, ADCs, PDCs, Bis-Abs, nanobodies
  • Vaccines
  • Biomarkers: DNA, mRNA, small molecule-based
  • Cellular and gene therapy products
  • Oligonucleotides
  • siRNAs
  • DNA and mRNA vaccines
  • Immune therapy cellular products
  • Stem cell products
  • Adenovirus, Adeno-Associated Virus (AAV), herpes simplex virus, lentivirus, oncolytic virus, retrovirus, poxvirus
  • Non-viral vectors e.g. plasmids
A scientist wearing safety goggles, a face mask, and gloves uses a pipette while working in a laboratory focused on bioanalytical development. Shelves with laboratory equipment and supplies are visible in the background.

Areas of Application

  • PK, TK and PD studies
  • Dose formulation analysis
  • Biodistribution analysis
  • Immunogenicity analysis
  • Immunophenotyping analysis
  • Cytokine release assays (in vivo & in vitro)
  • Receptor occupy analysis (in vivo & in vitro)
  • Tissue Cross Reactivity (TCR) evaluation
  • Biomarker analysis
  • Assays for IND filing purposes are validated per GLP guidelines by ICH/FDA/EMA/NMPA

Learn more about Pharmaron’s large molecule bioanalytical services

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