A new collaboration hopes to result in optimal media and process paramenters for stem cell therapies.
TAP Biosystems has joined the Centre for Commercialisation of Regenerative Medicine’s (CCRM) industry consortium to translate laboratory cell culture conditions into optimised processes and media for commercial production of cellular therapies.
TAP’s ambr system, an advanced micro bioreactor that replicates the characteristics of bioreactors at a 10-15 mL micro scale, will be installed at CCRM to determine optimal media components and process conditions for culturing natural killer cells and human stem cells at scale.
Since the cells are the final therapeutic product, there is a finer balancing act between cost and quality than with cells used to manufacture traditional biologics.
This partnership will provide an understanding of how cells behave in scalable culture formats, in order to produce clinically relevant numbers using affordable manufacturing strategies. The collaboration will initially focus on immunotherapy applications with hopes of expanding into other cell therapy applications in future.
Dr. Peter Zandstra, CSO at CCRM, explained: “TAP will be part of a 20 company consortium that invests in intellectual property and advises on regenerative medicine bottlenecks and opportunities, and acts as a ready receptor for new technologies developed at CCRM. TAP and CCRM will work together to develop suspension culture processes in bioreactors that can be translated for commercial manufacture of stem cell therapies. The goal is to reduce costs without compromising cell quality.”
Kim Bure, North American Business Manager for Regenerative Medicine at TAP Biosystems said: “The cost of generating and differentiating stem cells at clinically relevant scale is currently prohibitive, with media requirements sometimes in the range of hundreds of dollars per small scale culture.
“We believe our collaboration with CCRM will assist in defining a process to identify the key factors and optimum conditions for culture, in turn driving down the costs associated with scale-up and further allowing the production of high quality cell therapies within acceptable reimbursement ranges.”
Bure concluded: “CCRM is using an intelligent approach by automating design of experiment at an early stage, and we’re pleased that this innovative translation centre has chosen to work with us as part of that strategy.
“Through our collaboration, the ambr system and systems we develop from this partnership could be instrumental in helping drive down manufacturing costs and ultimately achieving the true goal of enabling these effective therapies to more rapidly reach the market and be made accessible to a wider number of patients.”
