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Recent Publications

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. 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.

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.
 
Alanna Evans and Stacey Johnson. CCRM: Cultivating a culture of cooperation to advance the global regenerative medicine industry. RegMedNet, February 2, 2017.

Lipsitz YY, Timmins NE, Zandstra PW. Quality cell therapy manufacturing by design. Nature Biotechnology. 393-400 (2016) doi:10.1038/nbt.3525 

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. 

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 http://oirm.ca/oirm-research/publications.