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:
- Monoclonal antibodies
- Bispecific antibodies
- 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.
- 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