I’m attending annual IBC Cell Therapy Bioprocessing meeting in Arlington. One of the major highlights of the first day for me was understanding the importance of “democratization” and affordability of therapeutic cell product manufacturing. Lowering the cost of cell product is a key to commercial success. If cost of cell product is very high, it will not be cost-effective, it will not be reimbursed, it will fail clinical adoption. So, in cell product development we must try very very hard to bring cost down!
Everybody was talking about automation as one of the best ways to bring cost of cell manufacturing down. Stefan Miltenyi (Miltenyi Biotec) said that “cell processing has to become less expensive”. He thinks that “automation is able to resolve many critical issues, related to manufacturing of autologous cell therapy products”. His company did a lot for development of cell processing automation, including the most recent multifunctional device CliniMACS Prodigy. He was talking about possibilities of combining Prodigy with clinical-grade sort-on-chip device MACSQuant Tyto.The company now is making GMP-grade antibody for Tyto.
Jon Rowley (Rooster Bio) used a term “democratization of cell technologies“, which I really like. He gave a great example of lowering cost of mesenchymal stem cells (MSCs) by implementation of automation:
Cost per million clinical-grade MSCs, expanded in: T-flask = $100-500, multi-layer vessels = $10-50, suspension bioreactors = $1-5.
The problem of growing “high cell mass” at low cost significantly amplified in research labs, which build prototypes of tissues and organs for pre-clinical studies. Such labs need to grow billions of MSCs and pay “crazy money” for it (example: 1B of MSC may cost you $100k in T-flask and $10k in CellSTACKs). If such tissue constructs will work, the only way to go to clinic is automation via using suspension bioreactors.
There is a good progress in development of suspension bioreactors and using microcarriers for MSCs expansion. For examples, PBS Biotech was able to achieve concentration of 3 million per ml in their vertical wheel bioreactors. Increasing cell concentration without compromising quality of the product, will allow to cut media usage and shorten the time of culture. Li Ren from Celgene just reported about generation of 1.2 trillions (!) of allogeneic placental MSCs per one process, using microcarriers in bioreactor. If you have to deal with high MSCs numbers, this is the only way to go in industrial manufacturing.
So, we can see huge investment and development in “cell therapy manufacturing toolbox”. This “toolbox” will enable successful translation of cell therapies. As Jon Rowley said, “we are in a phase of rapid advancement of cell manufacturing technologies”. So, we should take advantage of these advances to bring cost of manufacturing down.