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Recent Publications

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.
 

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

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.