Centre for Biologics Evaluation (Nanotechnology)

Health Canada, Ottawa, Ontario
What the facility does

Research to determine how modifications to starting materials affect quality attributes of nanomedicines and furthering the development of nanoscale reference materials

Area(s) of Expertise

The laboratory’s work involves adapting existing methods and developing new ones to analyze and understand sub-visible protein aggregation, performing regulatory research to understand the mechanisms by which alterations to the individual components of a nanomedicine affect its overall attributes, performing research to identify limitations regarding methodology utilized to characterize nanomedicines and performing research to identify emerging concerns regarding the use of nanotechnology/nanomedicines and to subsequently provide scientific responses to those concerns in this rapidly advancing field. The laboratory is also actively involved in the development of novel methods for nanoparticle fabrication as well as the development of nanoscale reference materials.

Research Services

The laboratory is capable of nanoparticle assessment via dynamic light scattering, single nanoparticle tracking analysis and resonant mass measurement. Additionally, the laboratory can also perform protein structure/stability assessment via circular dichroism spectropolarimeter, differential scanning calorimetry and isothermal titration calorimetry. The capability to characterize and quantify sub-visible particles in therapeutic formulations via micro-flow digital imaging analysis is also within the laboratory’s expertise.

Sectors of Application
  • Life sciences, pharmaceuticals and medical equipment

Name of equipment in use

Description of function

JASCO J-1500 Circular Dichroism Spectrophotometer

For assessing secondary and tertiary protein structure as well as protein stability

Malvern Panalytical NanoSight NS300

Automated analysis of size distribution and concentration of all types of nanoparticles from 10nm to 2000nm in diameter

Malvern Panalytical Archimedes

Particle Metrology System

Uses resonant mass measurement to detect and count particles between 50 and 5000nm

Fluid Imaging Technologies FlowCam VS series

A fluidics system that uses a flow cell and digital imaging system to characterize and count sub-visible particles

Thermal Analysis (TA) Instruments Nano ITC (Isothermal Titration Calorimeter)

A highly sensitive calorimeter capable assessing protein/protein or protein/ligand interaction

International Pharmaceutical Regulators Forum (IPRF) 

Title

URL

Biologics and Genetic Therapies Directorate

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-produ…

Nanoparticle size and efficiency affected by presence of fatty acids during albumin nanoparticle fabrication. PLOS ONE

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0189814

 

Toxicogenomics analysis of mouse lung responses following exposure to titanium dioxide nanomaterials. Mutagenesis

https://academic.oup.com/mutage/article/32/1/59/3865758

 

pHAST (pH-Driven Aptamer Switch for Thrombin) Catch and-Release of Target Protein.

Bioconjugate Chemistry

https://pubs.acs.org/doi/10.1021/acs.bioconjchem.6b00124

 

Evaluation of Microflow Particle Analysis for Sub-Visible Particles Formulated with Opaque Vaccine Adjuvant. PLOS ONE

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150229

 

Determination of Supplier-to-Supplier and Lot-to-Lot Variability in Glycation of +Re Hum Ser Alb Expressed Oryza sativa. PLOS ONE

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0109893

 

Generation of fatty acids from 1,2-dipalmitoyl-sn-glycero-3-phosphocholine/cardiolipin liposomes. J Liposome Res

https://www.tandfonline.com/doi/abs/10.3109/08982104.2012.747535?journalCode=ilpr20

 

Investigation of differences in thermal stability 2 recombinant human serum albumins with 1,2-dipalmitoyl-sn-glycero-3-Phos. J Phys Chem

https://pubs.acs.org/doi/10.1021/jp2125729

 

O-linked glycosylation leads to decreased thermal stability of interferon alpha 2b measured by 2 orthogonal techniques. Pharm Res

https://link.springer.com/article/10.1007%2Fs11095-011-0402-0

 

Influence of bovine serum albumin on secondary structure of interferon alpha 2b. Biologicals

https://www.sciencedirect.com/science/article/pii/S1045105609001821?via%3Dihub

 

Characterization of retention and pharmacokinetic properties of liposomal nanoparticles dihydrosphingomyelin. BBA-Biomembranes

https://www.sciencedirect.com/science/article/pii/S0005273607000314?via%3Dihub

 

Therapeutically rates of drug release achieved by varying drug to lipid ratio in liposomal vincristine. BBA-Biomembranes

https://www.sciencedirect.com/science/article/pii/S0005273606000113?via%3Dihub