Large Molecule Bioanalysis

Anapharm Bioanalytics offers an array of Ligand Binding Assays (LBA), including cell-based assays, and LC-MS/MS technology platforms tailored to support large molecule development programs from early preclinical through Phase I-III clinical stages:

  • LBA and LC-MS/MS analytical method development and validation.
  • Method transfer, optimization and cross-validation of sponsor-supplied methods.
  • Quantitative analysis in biological fluids and tissues for Pharmacokinetic, Pharmacodynamic (PK/PD) and Toxicokinetic (TK) studies including:
  • Peptides
  • Proteins
  • Monoclonal antibodies
  • Bispecific antibodies
  • Oligonucleotides
  • Biomarker testing.
  • Immunogenicity assays:
  • Anti-drug antibodies (ADA): safety assessment following a tiered approach including ADA screening and Positive ADA confirmation.
  • Neutralizing Antibodies (NAbs) by non-cell based (CLBA) and cell-based assays (CBA).
  • Cell-based assays for cell proliferation, ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, etc. (read more about our Cell Lab below)
  • Enzyme-linked immunosorbent assay (ELISA) with colorimetric, fluorescence and chemiluminescence readouts. Validation of commercially available ELISA kits.
  • MESO QuickPlex SQ 120 – MSD electrochemiluminescence (ECL) technology.
  • qPCR Quantstudio 5.
  • Precellys Evolution Homogenizer.

Cell Lab

  • A variety of cell-based assay format can be developed and validated such as Cell proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, etc.
  • The results readouts from the CBA include Absorbance, Fluorescence, Luminescence and will be measured with the ELISA plate reader or MSD.
  • Cell lab equipment includes:
  • Safety Cabinet type II, Telstar Bio II Advance Plus
  • HERAcell vios 160i CO₂ Incubator
  • Inverted microscope
  • Liquid Nitrogen Cryostorage
  • Benchtop Autoclave
  • Table top Centrifuge