With contributions from David Brindley
Manufacturing may not be the first thing that springs to mind when regenerative medicine is mentioned. Most will think of the enormous potential for cell therapies or transplantation or editing of faulty genes. However, having attended the fifth annual Informa Life Sciences Cell Therapy Manufacturing conference, it is clear that for these therapeutic applications to be realized, manufacturing is an essential consideration. Let’s explore why.
Imagine if every hospital had its own facilities to manufacture and expand therapeutic cells for use in patients: visualize hundreds of machines running in parallel, sealed off to the outside world, with all necessary manufacturing steps pre-programmed into an automated system. A hospital employee simply ‘plants the seed’ in the machine – in this case a small cell sample – and waits for a finished product that can go straight to the patient a few doors away.
In a somewhat controversial commentary published in Nature Biotechnology a few months ago, Octane Biotech employees, including the CEO Timothy Smith, suggested that a rethink of the way we manufacture autologous cell therapies (i.e. those from a patient’s own cells) is required.
At the moment, all cell therapy manufacture follows a similar manufacturing paradigm: there is production in a specialized, centralized facility designed for cell manufacture. For allogeneic cell therapies (i.e. those derived from a donor’s cells), this is sensible because relatively few “ideal” donors can be used to generate large cell numbers and, thus, economies of scale come into play as they do with traditional pharmaceuticals.
For autologous therapies, however, this might not be the case. A lower number of cells are likely to be required as they are only used on a single patient, thus limiting cost reductions due to scale. Further, transportation of cells to another facility, and back, increases the number of handling steps required for a product and increases the opportunity for errors to creep in. Manufacturing autologous therapies in the vicinity of the patient whose cells are being used would seem the logical choice; however, manipulating cells requires highly skilled staff, something which is simply not feasible to have in all institutions.
Addressing these conflicting facts, Octane Biotech has developed the Octane Cocoon, a fully automated, patient scale bioreactor that can be adapted for a variety of cell and tissue production processes. Similarly, Miltenyi Biotec (a CCRM industry consortium member) has developed a closed, “all-in-one” solution: the CliniMACS Prodigy.® One idea behind these products is that hospitals could adopt these systems (which in theory would require little specialized skill to operate), running many units in parallel, each with a different patient’s cells being produced.
Each hospital is, in Timothy Smith’s words, an orchard: the units are the trees; the cells are the apples that, once produced, are harvested and the cycle will repeat itself.
Of course, it is not as straightforward as I have made out here. In particular, regulation could be challenging: each individual hospital might need regulatory approval to manufacture cells, which could drive up costs and limit adoption. Also, adapting a fully automated system to diverse processes for producing different cell products could be challenging and will require significant validation against the ‘gold standard’ of highly skilled laboratory workers.
Octane’s or Miltenyi’s technology may or may not be the answer to autologous cell manufacturing; however, they certainly illustrate the importance of considering how a cellular product will be manufactured and highlight the potential application of exciting, innovative approaches to doing so.
Watch this space for more cell manufacturing-based posts over the next few weeks.
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