C&G Therapies: A Parallel Universe To mAbs?

The Medicine Maker recently published two enjoyable reads. First of all, there was no way in hell I was going to pass up an article on C&G manufacturing entitled “Of Plumbing And Poetry.” In this particular article, Sangamo CEO Sandy McCrae talks about leadership in the C&G space and the benefits of being a scientist/physician heading up a C&G biotech — especially when validating your technology in a clinical setting.

The second article features several more patient- and commercial-centric insights from Takeda and FerGene executives, along with McCrae. In addition to highlighting the growth needed in “non-glamorous” process development, McCrae also offered his thoughts on whether the C&G manufacturing process is unfolding and will streamline similarly to antibodies.

We’ve just begun to describe how to make cell therapies and therefore it’s going to take some years to perfect the processes. But there are now lots of people who used to work in monoclonals entering the cell and gene therapy industry (because that’s where the jobs are); and they talk about how monoclonals went from having many different specifications to a few specifications, and the important role that development played in the efficiency of manufacturing. We still have many specifications in cell therapy and we don’t quite know which ones are critical for efficiency. In short, I see many parallels with the monoclonal antibody field and I believe we are on an analogous journey.

In the pharma industry in general, we love to compare and contrast the progress we’re making in new industries with those that came before. In my biosimilar days, I was looking back at the small molecule generics space. In the C&G space, I find myself looking back at mAbs.

If you’re interested in hearing more on this topic, I’d point you in the direction of this podcast from BioProcess International. Here, Patrick Lucy, COO of manufacturing services organization Lykan Biosciences (and a former biosimilar compatriot of mine), shares his experiences when the demand for mAbs/recombinant proteins resulted in an outsourcing boom and capacity crunch. (Sound familiar?) Now, a new member of the cell therapy industry with 30 years of biologics history under his belt, Lucy paints the cell therapy “unknowns” we currently have in this space in a positive light.

There’s a lot of manufacturing opportunity within cell and gene therapy, just like there was in mammalian cell culture and engineered proteins. It’s no secret that cell therapy manufacturing in particular is quite challenging for a range of reasons….The logistics on the front end and the back end are challenging, but… the diversity of the cells that we’re trying to leverage in the space are sensitive; they’re naturally challenging to culture and expand. So, there’s a lot of opportunity for innovation in the cell therapy space in particular.