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 alQuality 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 alReport 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.

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.

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

CCRM works closely with the scientists affiliated with the Ontario Institute for Regenerative Medicine (OIRM), our partner organization. To read the published articles of OIRM members, please click