Biologics Characterization Facility

National Research Council Canada, Montreal, Québec
What the facility does

Accelerates development of safe, effective biologics therapeutics from discovery to clinical application using advanced characterization technologies.

Areas of expertise

The Biologics Characterization Facility provides high-resolution analytical infrastructure and specialized scientific expertise to accelerate candidate selection, developability assessments, and early-stage preclinical manufacturing development.  Operating under a rigorous quality management system with dedicated quality assurance (QA) oversight, the facility delivers cost-effective, phase-appropriate analytical methods tailored to the needs of emerging biopharma and academic innovators. 

Its cross-modality expertise spans monoclonal antibodies, bispecifics, fusion proteins, enzymes, viral vectors, virus-like particles (VLPs), and lipid nanoparticles (LNPs). This breadth enables a strong interdisciplinary perspective, supporting efficient troubleshooting of complex sample matrices, structural and chemical instability, and assay anomalies that may challenge single-modality laboratories. From formulation screening and stability studies to comparability assessments and technology transfer, the facility generates precise, reliable data required to demonstrate therapeutic potential, reduce technical risk and shorten development timelines.

Research services

Analytical platforms and assays

  • Perform chromatographic separations: Analyze biomolecules using size-exclusion, ion-exchange, hydrophobic interaction, reversed-phase, and affinity chromatography.
  • Conduct electrophoretic and immunoblot analyses: Separate and detect proteins using SDS-PAGE, CE-SDS, and Western blotting.
  • Characterize charge variants and isoforms: Assess protein heterogeneity using imaged capillary isoelectric focusing (icIEF).
  • Quantify targets using immunoassays: Perform ELISA with multiple detection modalities.
  • Assess particle size and aggregation: Characterize particles using Dynamic Light Scattering (DLS), Multi-angle Light Scattering (MALS), Nanoparticle Tracking Analysis (NTA), and nano-flow cytometry.
  • Measure binding kinetics and affinity: Evaluate molecular interactions using Surface Plasmon Resonance (SPR) and Biolayer Interferometry (BLI).
  • Perform spectroscopic analyses: Measure absorbance, fluorescence, and protein structure using UV-Vis and circular dichroism (near- and far-UV).
  • Quantify nucleic acids: Determine specific DNA and RNA copy numbers using qPCR and digital PCR (dPCR).
  • Measure biophysical properties: Assess pH, osmolality, and absolute viscosity of candidate formulations.
  • Detect impurities and contaminants: Measure endotoxin levels using Limulus Amebocyte Lysate (LAL) assays, residual host cell proteins (HCP) via ELISA, and residual host cell DNA using qPCR.
  • Evaluate thermal stability and unfolding: Characterize protein stability using Differential Scanning Calorimetry (DSC) and Differential Scanning Fluorimetry (DSF).
  • Analyze sedimentation behaviour: Determine biomolecular size, shape, and aggregation states using analytical ultracentrifugation (AUC).
  • Assess biological potency: Evaluate functional activity using tailored cell-based and enzyme-based assays.

Development and release testing

  • Develop and execute release assays: Design product-specific assays aligned with critical quality attributes.
  • Screen candidate developability: Perform high-throughput evaluation of lead candidates using complementary orthogonal assays.
  • Support process development: Conduct in-process testing for upstream and downstream manufacturing processes.

Stability and formulation

  • Conduct stability studies: Perform real-time, accelerated, and forced-degradation studies using validated, stability-indicating methods.
  • Manage stability programs: Design and execute short- and long-term studies for drug substance and drug product.
  • Optimize formulations: Develop fit-for-purpose formulations using high-throughput Design of Experiments (DoE).

Structure determination

  • Determine biomolecular structures: Deliver end-to-end “gene-to-structure” workflows including expression, purification, high-throughput crystallization, 3D structure determination.

Quality and compliance

  • Provide QA-reviewed documentation: Deliver quality-reviewed reports and complete technology transfer packages suitable for contract research, contract manufacturing, and GMP environments.

Facilities

  • Provide controlled laboratory environments: Support research within Biosafety Level 1 and Biosafety Level 2 (BSL-1/BSL-2) laboratories.
Sectors of application
  • Life sciences, pharmaceuticals and medical equipment
  • Manufacturing and processing
  • Containment and biosafety capacity: Provide Biosafety Level 1 and Biosafety Level 2 laboratory environments to support work with non-pathogenic and moderate-risk biological materials.
  • Liquid chromatography analysis: Separate and characterize biomolecules using size-exclusion, ion-exchange, reversed-phase, and hydrophobic interaction chromatography with UV/VIS, Fluorescence, Multi-angle Light Scattering (MALS) and Refractive Index (RI) detectors. (Waters Acquity UPLC, Waters Arc HPLC).
  • Plate-based biochemical and cell assays: Perform high-throughput ELISA, binding, and cell-based assays with absorbance, fluorescence, and luminescence detection (Agilent BioTek Synergy H1 multimode plate reader).
  • Binding affinity and kinetics analysis: Measure molecular interactions, determine binding affinity and kinetics, and perform epitope binning using label-free platforms (Cytiva Biacore T200 SPR; Sartorius Octet Red96 BLI and GatorBio Pivot HT BLI).
  • Protein separation and characterization: Separate, size, and quantify proteins with high resolution and throughput using capillary electrophoresis with minimal sample input (Revvity LabChip GX II Touch CE-SDS).
  • Charge variant analysis of biologics: Characterize protein charge heterogeneity and isoelectric point (pI) variants using imaged capillary isoelectric focusing (Bio‑Techne Maurice imaged cIEF).
  • Protein structural characterization: Assess secondary and tertiary protein structure using circular dichroism spectroscopy.
  • Particle sizing and nanoparticle analysis: Quantify and size particles and biomolecules using dynamic light scattering (DLS), nanoparticle tracking analysis, nano-flow cytometry, and UV/Vis-based approaches (Malvern Panalytical NanoSight NS500; NanoFCM NanoAnalyzer; Unchained Labs Stunner UV/Vis and DLS).
  • Thermal and stability profiling of biomolecules: Determine protein stability and unfolding properties using differential scanning calorimetry and nanoDSF-based approaches (Malvern Panalytical MicroCal DSC; NanoTemper Prometheus Panta).
  • Viscosity measurement: Measure absolute viscosity across defined shear and temperature ranges using small sample volumes with high precision (RheoSense m‑VROC II).
  • Nucleic acid quantification: Perform high-throughput, multiplex quantitative and digital PCR for precise absolute quantification of DNA and RNA (Thermo Fisher Scientific QuantStudio 7 qPCR; QIAGEN QIAcuity Four Digital PCR).
  • Macromolecular characterization in solution: Analyze size, shape, aggregation, and interactions of biomolecules using analytical ultracentrifugation (Beckman Coulter analytical ultracentrifuge).
  • Microscopy for cell-based assays: Acquire fluorescence and brightfield images for cellular analysis using hybrid upright/inverted microscopy (Echo Revolve microscope).