IWG Panel: The Future of CGT Manufacturing

Here are some excellent insights by leaders in the manufacturing of CGTs: Peter Olagunju, Fabian Gerlinghaus, Jason C. Foster, Michael Jester, Jason Bock, Robert Zamboldi. What are your thoughts?

1. Coming out of the “2021 sugar high”: The “sugar high” of funding in 2021 drove inefficient investment of capital in building in-house manufacturing facilities and inflated hiring. This realization has hit us all hard in the face, given today’s the current financial markets. However, the silver lining is that, today’s environment is forcing the industry to focus on high value-add accretive manufacturing partnerships and collaborations versus trying to do everything unilaterally by yourself.
2. Flexibility and standardization is talk of the town: Many panelists disagreed with the notion that each developers cell therapy manufacturing process is unique. In many cases, apparently up to 90% of the processes are similar, so why re-invent the wheel for each asset? Given the shorter cash-runway for most companies and that cell therapy manufacturing today still remains in a relatively nascent maturity stage, innovative closed-loop automated manufacturing aims to build ‘template’ manufacturing modules that allow for flexibility.
3. Talent retention rates are under 1.5 years: Staffing and talent continue to be one of the biggest obstacles to scaling. First, it is hard to find the right talent, and once found and trained, it is hard to retain the talent. The long working hours, difficult work environments (e.g., night shifts) and enticing offers by competitors is leading to “poaching”, and hence average retention time has shrunk to about 1.5 years. To find talent, manufacturers are partnering with local governments and colleges, and training recent graduates to serve as operators.
4. “Walk-away” automation could save time, space and costs: Automation has the potential to decrease the amount of real-estate and labor by up to 90%, thereby having the potential of reducing the cost of goods manufactured significantly. Additionally, this allows for the cell culture to be left largely unmonitored. This, therefore, could reduce the manpower required in the cleanroom, and save costs. Future automation could also include automated quality release testing.
5. Why it is better to make manufacturing investments early? Hitting clinical milestones was the push from investors, and hence careful assessment of future-proof scalable manufacturing processes was an after-thought. So if the asset, for which the manufacturing capabilities were built, did not perform well in the clinic, then these companies were left “flat-footed”. Hence, the panelists strongly advised on critically and strategically thinking of manufacturing processes early in the product lifecycle. The early consideration of manufacturing strategy is especially prescient given recent FDA guidance around limiting changes to manufacturing once the therapy has entered the clinic.
6. Number of doses per square foot: This was a new and an interesting metric that some of the panelists suggested. Compact or consolidated manufacturing technologies, combined with shorter manufacturing and quality testing timelines, all can contribute towards faster turn-around, lower costs and higher number of doses produced by a manufacturing facility.

Looking forward to seeing the impact this group of leaders will continue to have on the future of personalized medicine!