Dr Sowmya Viswanathan, head of CellCAN’s cell manufacturing working group and co-chair of the Cell Therapy Stakeholder Group (CTSG
) with health Canada, is leading a new monthly feature
in the Signals Blog from CCRM.
With all the recent developments in cell and gene therapy, including the FDA approval of new treatments for diseases such as B-cell Acute Lymphoblastic Leukemia in children and young adults and non-Hodgkin lymphoma, the production of cells for these treatments is no longer bounded by the walls of academia. It is a reality that must be carefully analyzed in order to overcome the challenges of this as much from a cell processing stand point than a regulatory staone.
‘’The requirement to manufacture millions of doses of cell- and gene-based therapies no longer seems an academic exercise based on theoretical case studies, but a new reality. As with any emergent field, a number of processing and analytical challenges must be systematically addressed to enable the transformative potential of cell- and gene-based therapies… A systematic and academic-research based approach to investigate and evaluate the challenges facing successful development and implementation of Cell and gene therapy products (CTPs/GTPs) would thus be timely.
Under a new monthly feature that I will lead, invited guest writers will speak to specific bioprocess and bioanalytical challenges, and proposed solutions in the development of their CTPs/GTPs. The main objective is to create a Canadian-led ecosystem on a unified and emerging theme on core bioprocess and bioanalytical functions that can be broadly applied to different CTPs/GTPS.’’
Congratulations to Dr. Viswanathan for this new initiative! Read the complete first article from Dr. Viswanathan here