Kathie Schneider, global commercial lead at Terumo Blood and Cell Technologies, talks to GEN about how Terumo is tackling risk reduction in cell therapy manufacture.
GEN: Why do you think it’s important to start risk reduction in the clinic?
Cell therapy involves working with sick patients, and many times there isn’t a large quantity of cells to work with. If you work with clinicians to get a better apheresis, then you get better quality cells to work with, which reduces risk before you get into the manufacturing suite.
GEN: How have you tried to reduce risk during fill and finish?
The industry is working towards being more functionally closed, and we have a functionally closed automated process to help with risk reduction.
GEN: What are the risks of a manual fill-and-finish process?
When you’re using a manual process and you’re sitting at the hood, you have open connections, multiple syringes, and there are lots of opportunities for air [and contamination] to get in.
GEN: What other ways are you innovating in cell therapy bioprocessing?
We’ve got an alternative way of processing cells in the cell expansion step, which uses hollow fiber technology. I’m not aware of anyone else using [this method] for cell and gene therapy, but it’s an emerging technology in other areas of biomanufacturing as they shift from fed batch to perfusion technologies.
GEN: How does that work?
If you imagine the inner diameter of a fiber and cut it in half, you have much more space and coverage than [for example] a cell bag. The cells grow inside the fibers, so they’re in proximity with each other, and the media weaves through, allowing for constant access to fresh nutrients and faster waste removal. [The fibers are tiny, each with a diameter of about two hundred micrometers, and are contained in two chambers separated by a semi-permanent membrane].
GEN: How do hollow fibers reduce risk?
When we talk about the [parts of the manufacturing process with the] highest degrees of risk, cell expansion is a major one. Because we’re automatically feeding [the cells], there’s less human interaction and it takes less time than a manual process.
