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.
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.