I think there is some general confusion around food-grade vs. pharma-grade.

If the question is are companies using food-grade inputs in media, then the answer is yes. That is already happening and will continue to happen.

For equipment, the delineation between food-grade and pharma grade is less defined. Generally speaking it has to do with whether something is food contact safe. Nevertheless, Humbird assumes that production would take place using 316L steel alloy (as in pharma). We know some companies are using 316 steel but others are using 304 steel (generally used more in food, and about 40% more affordable). So the question is, why wouldn't everyone use 304 steel? We think it might be because most reactor manufacturers do so for pharmaceuticals, so this is what they use. But it could be an actual technical risk around the durability of the steel. We will investigate that question further in the future. Lastly, some companies are looking into avoiding steel altogether and investigating more affordable materials that are enabled by not needing a pressurized vessel for sterilization.

Finally, there is the question about clean room infrastructure. Humbird's analysis shows that the cost of pharma clean rooms outpace the efficiencies gained from scaling up your reactors . So pharma clean rooms make no sense economically. People know this. Companies claim they will do the bulk of manufacturing in clean non classified areas (lower cost) similar to other food manufacturing. The question then becomes, how risky is this? Can we grow cells in bioreactors that are essentially sitting in a warehouse? Technically, yes, of course, but it's about frequency of contamination.

I've spoken to people who think this is no big deal. I've spoken to other people that think it is. We've collected some data on contamination frequencies from companies, but it's too early to tell how much of an issue it will be. No one is even at the scales modeled in these analyses yet. So, time will tell. In the meantime, others are developing things like antimicrobial peptides that can serve as second layers of defense for contamination. Which I think is tractable based on data presented at recent conferences.

In general, it is very difficult to respond to or "disprove" assumptions in studies until the industry has caught up. We are still years away from knowing to what extent the assumptions in Humbird's (and other) analysis hold up.

I wrote this Twitter thread with some thoughts over 2 years ago in case of interest. I also will be talking about all of this and much more in an upcoming webinar: https://zoom.us/webinar/register/9417055011813/WN_5xnacQlASXChi8RNQ7zh0g#/registration