Ten years ago, ‘cultivated meat’ grown from cells ex vivo left the realm of science fiction and hit the headlines when the “world’s first lab-grown burger” was cooked and eaten at a conference in London. Today, although the first regulatory “greenlight” has been issued in the US, and despite public tastings in Singapore and at the COP27 climate summit, we are still some distance from seeing slaughter-free sausages and steaks in the supermarket.
This article explores some of the technical, legal, and commercial hurdles which must be overcome if cultivated meat is to leave the lab and turn its challenges into opportunities. We’ll also look at how the innovators who are able to do solve these challenges can maximise the value of their innovation.
PERFECTING THE CULTIVATED MEAT PROCESS: ADDITIVES, PLATFORMS, AND CELLS
Early cultivated meat projects were, essentially, rooted in techniques developed research and regenerative medicine. This provided a springboard to proof-of-concept, but it was not without drawbacks.
For example, a common additive in cell culture is foetal bovine serum (FBS), a rich blend of growth factors and nutrients that supports cell growth. However, FBS can only be obtained from cows during slaughter. In addition to increasing cost, this undermines animal-welfare and environmental arguments for cultivated meat.
Efforts to develop animal-free substitutes for FBS are already underway, with industry leaders GOOD Meat, Upside Foods, Mosa Meat, and Aleph Farms all announcing the completion of their own proprietary blends. Further improvements that go beyond merely substituting for FBS but surpassing it will be highly desirable. Whilst many specialist growth factors and hormones remain significant cost bottle-necks, similar issues exist around creating cell lines with the required combination of fast growth-rates and controllable pluripotency.
Although the field is still developing, it is unclear what the eventual landscape will look like.
Will it be dominated by proprietary formulations, with patent thickets and regulatory barriers creating “walled gardens” that exclude late entrants?
Alternatively, will there be shared standard formulations, perhaps provided as specialist off-the-shelf solutions?
If both coexist side-by-side, providing superior growth may not be enough to win the format war, as affordability and openness of the platforms could play the decisive role. Regardless, competition in this and related areas is likely to be fierce.
SCALING UP AND 'THE COMMODITY PROBLEM'
Whilst it is possible to produce lab-grown meat unprofitably in small batches, the challenge is to do so at commercial scale. Despite increasing scepticism of late around this issue, it is undeniable that costs of production must fall to compete with conventional meat.
One obstacle to scaling production is the sensitivity to contamination. Owing to its background in research, cultivated meat cells are very sensitive to bacterial contamination, necessitating extreme and costly sterilisation. Working at less stringent food-grade culture conditions - like those used to make cheese or beer - would reduce costs significantly. Advances that decrease cell doubling time, enhance endotoxin resistance, or provide active antimicrobial capabilities might provide solutions to this challenge.
Another area for innovation is in feedstocks. Cells in culture absorb nutrients from their media, and commodity-priced meat will need to use a commodity-priced feedstock. Novel platforms derived from low-grade corn, agricultural waste like straw, or grown by engineered algae and cyanobacteria are all promising avenues that may provide the killer solution.
Advantageously for innovators, any improvements in working at scale are likely to have applications outside of cultivated meat. This is where licensing their technology to the precision fermentation and pharmaceutical industries could provide valuable revenue streams even before bringing their products to market.
IF YOU CAN'T STAND THE HEAT... DEALING WITH THE COMPETITION
Cultivated meat is already becoming a crowded field, with over 150 active companies by the end of 2022. The patent landscape is also establishing fast, with broad patent claims already granted as new applications publish daily with incredibly ambitious scope.
Already, the appetite for contentious activity can be seen in a number of opposition and third-party observations already filed at the European Patent Office (EPO). This is a daunting prospect for even established players. The risks of falling foul of a competitor’s IP rights are surpassed only by the potential rewards of ensnaring them in yours.
A robust IP strategy is key in such a competitive field, and it is never too early (or too late!) for innovators to plan their approach.
Proactive innovators will, borrowing the well-worn playbook of biologic drugs, build a set of overlapping rights covering different aspects of the process, intermediates, and finished products, providing layers of protection around the process to shore up their position.
Meanwhile, performing patent landscape analysis to establish freedom-to-operate early on can avoid major costs further down the development cycle. Where obstructive rights exist, taking an active approach towards clearing the way could not only provide a runway to launch, but provide a chilling effect on the competition whilst signalling to potential investors.
THE BIGGER PICTURE: LEGAL, REGULATORY, AND COMMERCIAL HURDLES
For those lucky enough to have sampled it, cultivated meat has received glowing reviews. Perhaps this is to be expected, given its scarcity and the atypical degree of interest shown by its consumers. However, recent developments suggest that whilst the public at large may remain open-minded, legal and regulatory barriers may block the way for cultivated meat.
Proposals in the UK to ban naming vegan “mylk” with reference to the dairy products for which they substitute should concern those in cultivated meat, who may find their products similarly branded as “deceptive”. Meanwhile, a bill tabled in Italy proposes banning cultivated meat altogether, and the regulatory environment in Europe is still uncertain. Innovators will need to keep a keen eye on developments in all key markets, but the relative novelty of the field means that there is a real opportunity for those with the means to shape public perception policy.
Cultivated meat is right on the cusp of crossing over from a niche technology into one not only in the public eye but, hopefully, their shopping baskets. Important questions about sustainability, cost, and taste are already starting to appear in national newspapers. Despite the technology remaining at the early stages, decisions made now about how to protect, promote, position, and exploit this work are likely to have long-lasting consequences, and the foods of tomorrow will be made by those who plan for success today.
Andrew Tindall is a member of Potter Clarkson’s dedicated food and agritech team. If you would like to discuss how to maximise the value of any innovations you are working on within these fields, please contact us today.
