Dr. Michel Girard

Research Scientist

Research in biomolecule separation techniques for assessment of quality, purity and batch consistency of biotherapeutic products.

Health Canada

Current research and/or projects

Development of new physico-chemical separation methods for biomolecules based on high performance liquid chromatography and capillary electrophoresis.

Research and/or project statements

  • Investigation of novel analytical technologies
  • Application of multi-dimensional separation techniques for the assessment of complex biologics
  • Analysis of Subsequent Entry Biologics (Biosimilars)
  • Influenza vaccine characterization
  • Assessment of finished drug products

Professional activities / interests

  • Regular participant in international collaborative studies on harmonization of standards and methods organized by World Health Organization, European Pharmacopoeia, United States Pharmacopeia, and United States Food and Drug Administration
  • Close cooperation with national and international organizations such as National Research Council Canada and National Institutes for Food and Drug Control (China)

Education and awards

  • Ph.D., Chemistry, Carleton University, 1985
  • M.Sc., Chemistry, Carleton University, 1981
  • B.Sc., Chemistry, Université du Québec à Chicoutimi, 1977

Key publications

Mark JK, Dionne S, Cyr TD, Boucher S, Girard M, Hefford MA. Utility of standard pharmacopeial and nonpharmacopeial methods in distinguishing folded, unfolded, and process variant forms of interferon α-2. Journal of Pharmaceutical Sciences. 101 (10): 3672-3686 (2012).

Boucher S, Kane A, Girard M. Qualitative and quantitative assessment of marketed erythropoiesis-stimulating agents by capillary electrophoresis. Journal of Pharmaceutical and Biomedical Analysis. 71: 207– 213 (2012).

Girard M, Puerta A, Diez-Masa JC, de Frutos M. High Resolution Separation Methods for the Determination of Intact Human Erythropoiesis Stimulating Agents. A review. Analytica Chimica Acta, 713: 7- 22 (2012); doi:10.1016/j.aca.2011.11.041

Lorbetskie B, Wang J, Gravel C, Allen C, Walsh M, Rinfret A, Li X, Girard M. Optimization and qualification of a quantitative reversed-phase HPLC method for hemagglutinin in influenza preparations and its comparative evaluation with biochemical assays. Vaccine, 29(18):3377-3389 (2011).

Larocque L, Bliu A, Xu R, Diress A, Wang J, Lin R, He R, Girard M, Li X. Bioactivity Determination of Native and Variant Forms of Therapeutic Interferons. Journal of Biomedicine and Biotechnology, Vol. 2011, Article ID 174615, 11 pages (2011); doi:10.1155/2011/174615.

Gravel C, Li C, Wang J, Hashem AM, Jaentschke B, Xu K-W, Lorbetskie B, Gingras G, Aubin Y, Van Domselaar G, Girard M, He R,  Li X.  Qualitative and quantitative analyses of virtually all subtypes of influenza A and B viral neuraminidases using antibodies targeting the universally conserved sequences. Vaccine, 28(36): 5774-5784 (2010).

Garcia- Cañas V, Lorbetskie B, Cyr TD, Hefford MA, Smith S, Girard M. Approach to the profiling and characterization of influenza vaccine constituents by the combined use of size-exclusion chromatography, gel electrophoresis and mass spectrometry. Biologicals, 38:294-302 (2010).

Diress A, Lorbetskie B, Larocque L, Li X, Alteen M, Isbrucker R, Girard M. Study of aggregation, denaturation and reduction of interferon alpha-2 products by size-exclusion high-performance liquid chromatography with fluorescence detection and biological assays.  Journal of Chromatography A, 1217:3297-3306 (2010).

Storms SM, Feltus A, Barker AR, Joly MA, Girard M. Determination of Somatropin Charged Variants by Capillary Zone Electrophoresis: Optimisation, Verification and Implementation of the European Pharmacopoeia Method.  PharmEuropa Scientific Notes, 2009-1: 25-35 (2009).

Nunnally B, Park SS, Patel K, Hong M, Zhang X, Wang SX, Rener B, Reed-Bogan A, Salas-Solano O, Lau W, Girard M, Carnegie H, Garcia-Cañas V, Cheng KC, Zeng M, Ruesch M, Frazier R, Jochheim C, Natarajan K, Jessop K, Saeed M, Moffatt F, Madren S, Thiam S, Altria K. A Series of Collaborations between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis: Additional Instruments/Buffer. Chromatographia, 66P:955-961 (2007).

García-Cañas V, Lorbetskie B., Bertrand D., Cyr T.D. and Girard M. Selective and quantitative detection of influenza virus proteins in commercial vaccines using two-dimensional high performance liquid chromatography and fluorescence detection. Analytical Chemistry, 79:3164-3172 (2007).

 

Affiliations

  • Adjunct Professor, Université du Québec à Chicoutimi, Department of Sciences
  • Member, Group of Experts No. 6 (Biotech Products) of the European Pharmacopoeia
  • Member of Advisory Committee for the Bachelor degree in Biotechnology at the Cité Collégiale (Ottawa, ON)