Reports
2024 Success Stories. Life Sciences Ontario. December 2024.
Artificial Intelligence Talent in Canada. The Conference Board of Canada. November 7, 2024.
Canadian Centre for the Innovation Economy report: Risky business. The Conference Board of Canada. September 4, 2024.
Canadian Centre for the Innovation Economy report: 2024 Innovation Report Card. The Conference Board of Canada. April 11, 2024.
2023 Success Stories. Life Sciences Ontario. November 2023.
2022 Success Stories. Life Sciences Ontario. November 2022.
Out of the Lab, into the Patient: Canada’s Commercial Opportunity in Cell and Gene Therapy Manufacturing. Innovation Economy Council. April 11, 2022.
Global Expert Mission Advanced Therapies in Canada 2020 report. Innovate UK, Knowledge Transfer Network and UK Research and Innovation. December 2020.
Magnetic North: How Canada Holds its Own in the Global Race for Innovation Talent. Innovation Economy Council. December 2, 2020.
Factory Forward: How Advanced Manufacturing is Retooling Ontario’s Industrial Heartland. Innovation Economy Council. July 7, 2020.
The Post-Viral Pivot: How Canada’s Tech Start-ups can Drive the Recovery from COVID-19. Innovation Economy Council. April 29, 2020.
Alanna Evans and Stacey Johnson. CCRM: Cultivating a culture of cooperation to advance the global regenerative medicine industry. RegMedNet. February 2, 2017.
Journal Articles
Abdulrahman Alsultan, Dominique Farge, Sven Kili, Miguel Forte, Daniel J Weiss, Felix Grignon, Jaap Jan Boelens. International Society for Cell and Gene Therapy Clinical Translation Committee recommendations on mesenchymal stromal cells in graft-versus-host disease: easy manufacturing is faced with standardizing and commercialization challenges. Cytotherapy. 2024 October.
Yale S. Michaels, Lauren J. Durland, Peter W. Zandstra. Engineering T Cell Development for the Next Generation of Stem Cell-Derived Immunotherapies. GEN Biotechnology. Vol. 2, No. 2, April 2023. https://doi.org/10.1089/genbio.2023.0008.
Stephen Sullivan, Patrick Ginty, Siofradh McMahon, Michael May, Susan L. Solomon, Andreas Kurtz, Glyn N. Stacey, Annelise Bennaceur Griscelli, Ronald A. Li, Jacqueline Barry, Jihwan Song, Marc L. Turner. The Global Alliance for iPSC Therapies (GAiT). Stem Cell Research. Volume 49, December 2020, 102036. https://doi.org/10.1016/j.scr.2020.102036.
Shuohao Huang, Azher Razvi, Zoe Anderson-Jenkins, Anne-Marie Lavoie, Gary M. Pigeau, Danylo Sirskyj, Ming Gong. Process development and scale-up of pluripotent stem cell manufacturing. Cell & Gene Therapy Insights 2020; 6(9), 1277-1298. doi: 10.186/cgti.2020.141.
Richard L. Carpenedo, Sarah Y. Kwon, et al. Transcriptomically Guided Mesendoderm Induction of Human Pluripotent Stem Cells Using a Systematically Defined Culture Scheme. Stem Cell Reports. Volume 13, Issue 6, December 10, 2019, pages 1111-1125.
A.T. McLeod, S. Leung, J.P. Yuh, A. Ghorbani, R. Ramanuj, S. Hoover. A chimeric approach to purifying lentiviral vectors for CAR-T. Cytotherapy. 2019 May.
Mario A. Torres-Acosta, et al. Ex vivo Manufactured Neutrophils for Treatment of Neutropenia – A Process Economic Evaluation. Frontiers in Medicine. 2019 March doi.10.3389/fmed.2019.00021.
Stephen Sullivan, et al. Quality control guidelines for clinical-grade human induced pluripotent stem cell lines. Regenerative Medicine. 2018 Sep 12. doi: 10.2217/rme-2018-0095.
Gary M. Pigeau, et al. Report of the international conference on manufacturing and testing of pluripotent stem cells. Elsevier Biologicals. 2018 August. doi: 10.1016/jbiologicals.2018.08.004 p.1045-1056
Gary M. Pigeau, Elizabeth Csaszar and Aaron Dulgar-Tulloch. Commercial Scale Manufacturing of Allogeneic Cell Therapy. Frontiers in Medicine. 2018 August 22. doi: 10.3389/fmed.2018.00233.
Iyer R, Bowles P, Kim H, Dulgar-Tulloch A. Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges. Frontiers in Medicine. 2018 May 23. doi: 10.3389/fmed.2018.00150.
Bedford P, Jy J, Collins L, Keizer S. Considering Cell Therapy Product “Good Manufacturing Practice” Status. Frontiers in Medicine. 2018 Apr 30. doi.org/10.3389/fmed.2018.00118.
Ogbogu U, et al. Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy. Healthcare Policy. 2018, 13(3), 10-19. doi:10.12927/hcpol.2018.25401.
Advanced Therapies Investment Report 2017: The Challenges and Opportunities of the Advanced Therapy Sector. Phacilitate, Biotech and Money co-publication. July 2017.
Chisholm J, Bhatt S, Chaboureau A, Viswanathan S. Strategy for an abbreviated in-house qualification of a commercially available Rapid Microbiology Method (RMM) for Canadian regulatory approval. Cytotherapy. 2017 Oct 20. pii: S1465-3249(17)30703-X. doi: 10.1016/j.jcyt.2017.09.004.
Williams BA, Law AD, Routy B, denHollander N, Gupta V, Wang XH, Chaboureau A, Viswanathan S, Keating A. A phase I trial of NK-92 cells for refractory hematological malignancies relapsing after autologous hematopoietic cell transplantation shows safety and evidence of efficacy. Oncotarget. 2017 Jul 12;8(51):89256-89268. doi: 10.18632/oncotarget.19204. eCollection 2017 Oct 24.
Chisholm J, von Tigerstrom B, Bedford P, Fradette J, Viswanathan S. Workshop to address gaps in regulation of minimally manipulated autologous cell therapies for homologous use in Canada. Cytotherapy. 2017 Sep 27. pii: S1465-3249(17)30689-8. doi: 10.1016/j.jcyt.2017.08.015.
Kevin Lannon, James A. Smith, Kim Bure and David A. Brindley. Quantitative risk assessment of bioaccumulation attributable to extractables and leachables in cellular immunotherapy biomanufacturing. BioProcess International, November 16, 2016.
David A. Brindley, Maya Fuerstenau-Sharp, James A. Smith, Kim Bure, David Pettitt, Kyriacos Mitrophanous, Georg Holländer, Paul Predki, Andrew Slade and Peter Jones. Emerging platform bioprocesses for viral vectors and gene therapies. BioProcess International, April 18, 2016.
David A. Brindley, James A. Smith, Brock Reeve, Kim Bure, Zeeshaan Arshad, Franziska Faulstich, David Pettitt, Georg Holländer, Andrew Ball, Kiara Biagioni, Sunil Mehta, Rajan Choudhary and Hussein Al-Mossawi. Automation of CAR-T cell adoptive immunotherapy bioprocessing: Technology opportunities to debottleneck manufacturing. BioProcess International, April 18, 2016.
Lipsitz YY, Timmins NE, Zandstra PW. Quality cell therapy manufacturing by design. Nature Biotechnology. 393-400 (2016) doi:10.1038/nbt.3525
Rahul Rekhi, James A. Smith, Zeeshaan Arshad, MacKenna Roberts, Chas Bountra, Ian Bingham, Kim Bure. Decision-support tools for monoclonal antibody and cell therapy bioprocessing: Current landscape and development opportunities. BioProcess International, December 16, 2015.
Richard Grant, Mark Curtis, and Meredith Brown. Planning for commercial scale of cell therapy and regenerative medicine products, part 2. BioProcess International. October 2015 13 (9)s.
James A. Smith, Kelvin S. Ng, Benjamin E. Mead, Sue Dopson, Brock Reeve, James Edwards, Matthew J. A. Wood, Andrew J. Carr, Kim Bure, Jeffrey M. Karp and David A. Brindley. Extracellular vesicles commercial potential as byproducts of cell manufacturing for research and therapeutic use. BioProcess International, April 14, 2015.
Bubela T and Viswanathan S. Bringing regenerative medicine to the clinic: the future for regulation and reimbursement. Regen. Med.(2015) 10 (7), 897-911
Viswanathan S and Bubela T. Current practices and reform proposals for the regulation of advanced medicinal products in Canada. Regen. Med. (2015) 10(5), 647-663
Lisa Willemse, Ubaka Ogbogu, Stacey Johnson & Michael Rudnicki. Global Update: Canada. Regen. Med. (2012) 7(6 Suppl.), 132-135
