Cultured meat involves producing meat products from animal cells cultivated in bioreactors in a controlled and sterile environment—and it is on the path to revolutionizing the way we think of food. 

Investments to date are focused primarily on research and development, as well as on scaling up production capabilities to bring the first cultured meat products to market. In fact, the cultured meat industry now includes more than 150 cultivated meat companies backed by about $3 billion in investments¹, according to the Good Food Institute. 

There are several factors driving growth. At a high level, they include:

• Environmental Impact: Cultured meat has been promoted as a more environmentally friendly alternative to traditional livestock farming, as it could require significantly less land, water and energy use, and generate lower greenhouse gas emissions compared to conventional meat production methods. 
• Global Food Supply Chain Security: There are concerns about whether the world’s population—which is projected to expand to approximately 10 billion by 2050—can adequately meet its protein solely through traditional meat production, which is expected to increase 60% by that time to meet the need.
• Animal Welfare and Ocean Preservation: Cultured meat addresses concerns about animal welfare in industrial livestock farming and efforts to protect our oceans, which are constantly under pressure from overfishing. Cultured seafood would immediately bring relief to the ecosystem and offer products without contaminants like microplastics and mercury.
• Food Innovation: Cultured meat offers the opportunity to replace conventional meat, improve existing plant-based products that have not yet met consumer needs, and create new meat products that haven’t been available.

Clearly, the emergence of cultured meat has sparked a paradigm shift in the food industry. By leveraging cutting-edge biotechnologies developed in the life science industry and learning from existing big food processes and food regulations, it is possible to advance cultured meat as a sustainable and ethical solution to feed a growing global population.  

Cultured Meat: Spurred by Collaboration

A vital component of advancing the cultured meat industry is strong collaboration among life science companies, academia, government affairs, food companies and the startups producing the cultured meat products. This is necessary for understanding the needs to support go-to-market today, as well as the target requirements for the future to help develop the enabling technologies and solutions required for mass market penetration.

A good place to start is reviewing the differences between producing biologics and cultured meat. At a high level, they appear similar, but the primary differentiator is the final product. For cultured meat, the cells will be harvested to create the meat product and then consumed. For biologics, the active pharmaceutical ingredient (like a therapeutic antibody) is what the cells secrete, which is harvested and prepared most often for injection. For cell therapy, the cells are the product, and after culturing they should maintain relevant quality attributes prior to injection in the patient in the clinic.

Where similarities exist are the key raw material inputs that influence product quality attributes, like cells and cell culture media, and the general bioprocesses involved for scaling cell cultures. For cultured meat, partnerships, newly available commercial sources of raw materials and recent publications in journals are providing insights for how to characterize the cell types targeted for products from a variety of species, such as avian, porcine, bovine, fish and exotics—like crocodile—that have only limited research or have not been studied before for application in scaled bioprocesses. These developments have led to an understanding of how to feed the cultures—for instance, determining what nutrients are required, how much of each nutrient, and how changes in formulation can impact yield and quality attributes. These fundamental research efforts, in addition to studying the unit economics required for commercial viability, make it possible to adapt and focus on building a fit-for-purpose cultured meat cell culture media supply chain of raw materials for food production that balances performance, quality and cost. For example, to make a product the industry can use, our team at Merck KGaA, Darmstadt, Germany, has engaged internal quality, regulatory and manufacturing experts to implement the appropriate quality management system that includes Hazard Analysis Critical Control Point (HACCP) and food safety plans in production that enables the creation of documentation to support startups as they work with regulatory authorities to bring first products to market.

From a regulatory perspective, the life science industry is well-positioned to help the cultured meat industry prepare to go to market. In the U.S., cultured meat production falls under the joint regulation of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). However, when it comes to cultured seafood, the FDA has exclusive authority. The FDA is also the sole regulatory agency for clinical investigations, drugs, biologics and medical devices. In cultured meat production, the FDA oversees the entire process, from the initial cell isolation to the harvesting of cells or meat, while the USDA is responsible for inspecting facilities and ensuring compliance with labelling requirements. One thing is clear—cultured meat must adhere to existing food regulations and policies—thus, cultured meat startups are highly encouraged to engage early and often with the regulatory authorities.

The approval process involves a comprehensive product review and utilizes a hazards-based approach that considers the raw materials used and potential toxicity at intended use. As of January 2024, two companies—UPSIDE Foods and GOOD Meat—have made it through the process with approval to sell their cultured chicken products on the market in the U.S. GOOD Meat had previously secured approval for sale in Singapore in 2020. Aleph Farms is the first ever cultured meat company to apply for regulatory approval in Europe with its submission filed in July 2023 and received the “No Question Letter” in January 2024 to continue forward on their path to market. It should be noted that approval is independent of commercial availability or viability and is required for all products seeking market entry. These initial regulatory approvals have laid an excellent foundation for the industry for others to follow, with publicly available details on the process and engagements with regulatory authorities.

Similar to life science products, safety is the top priority for regulators evaluating cultured meat products. Since life science companies are likely to serve as enabling technology providers for the emerging industry, it is crucial for startups to clearly communicate their market entry requirements. This ensures that these technology partners comprehend the regulatory challenges and risks, enabling them to offer guidance on quality standards and technical specifications for raw materials such as cells, media, bioreactors, environmental safety testing, among others. With these learnings, action can be taken to implement quality management systems for production like HACCP plans for manufacturing raw material inputs, food certifications at facilities, and alignment with regulators.

An additional similarity with life science products is that there are regional considerations for regulatory oversight of cultured meat. Some regions, like the U.S. and Singapore, have proven to be progressive, with high levels of government engagement with startups to accelerate timelines. Conversely, other regions, like the European Union, will likely come after precedent in other areas under the Novel Foods regulatory framework. Thus, it is important for technology enablers to build capabilities to meet the regulatory needs in different geographies to support the industry.

Strengthening the Life Science Link in Manufacturing

To deliver the first products in the early years of the cultured meat industry, companies have been leveraging considerable bioprocess knowledge from the pharmaceutical industry as a starting point. For example, best practices for cell isolation and banking, preparing powdered cell culture media in mixers followed by established filtration and sterilization procedures, and culturing cells in highly automated stirred tank bioreactor systems. Products and equipment used by life science companies are suitable for cultured meat companies today as a starting point. However, it is clear that we must prepare to deliver fit-for-purpose product innovations to meet the needs specific to the cultured meat industry. This includes a clear effort to reduce costs for the industry to facilitate commercial viability in time. At this stage, companies are evaluating not just stirred tank bioreactors but also hollow fiber systems and novel culture modalities to drive productivity metrics to new heights. As for bioreactor mode, fed-batch, perfusion and continuous processes are being considered, each with benefits and drawbacks related to yield, cost, and production times. Innovation and optimization in bioprocessing are essential to minimizing the cost of goods for operational costs and capital expenses on a commercial scale, which is why companies are placing tremendous resources on the process and product development efforts.

Today, the cell culture media accounts for upward of 50% of the operational manufacturing costs, while large-scale bioreactor systems at the 20k liter scale and above are commanding double-digit million capital investments. Given the cost pressures from using existing pharma technology, cultured meat companies are working feverishly to address this at the development scale, through internal developments and partnerships across the industry, prior to moving into larger scale facilities in hopes this will bring them closer to commercial viability. Multiple cultured meat startups have now delayed building larger scale facilities to focus on maximizing existing infrastructure before investing in further capital expenditures.

Buying existing classical basal media solutions off the shelf composed of pharmaceutical raw materials ranges from $10 to more than $20 per liter, depending on formulation. To address this, our team has focused on building a cultured meat relevant raw material supply chain that balances quality, performance and cost to enable the production of cell culture media suitable for cultured meat and seafood manufacturing. This approach delivers media solutions specific to the industry, including suitable quality documentation derived from an industry appropriate quality management system, a reduction in competition for pharma raw materials, and bringing competitive pricing to the industry over time with scale due to the lower cost structure of some food-grade raw materials and realized production efficiencies.

At our company, scaled manufacturing strategies, combined with a dedicated supply chain of raw materials suitable for cultured meat are already driving basal media prices below $1 per liter today for standard formulations, like variations of Dulbecco’s Modified Eagle Medium. To achieve $0.50 per L, cultured meat startups should focus on reducing raw material numbers in formulations and optimizing concentrations of media to meet specific needs of the cells used in their respective bioprocess. Some cultured meat startups are reporting they have reached this target, which is promising for product unit economics and commercial viability. To drive down to $0.25 per liter and meet the projected media volume needs for production, facilities of the future that are designed to handle the production of thousands of tons of dry powdered media should come online with smart manufacturing features and heavily automated operations. At this point, conventional meat and food companies could potentially implement their strengths in the supply chain, manufacturing and distribution capabilities to deliver further efficiencies for mass global production efforts.

Conclusion