As the field of cultivated meat continues to advance, so does the need to address one of the most pressing concerns among consumers: food safety. The idea of producing meat without raising or slaughtering animals is novel and, understandably, raises many questions and chief among them is whether this new category of food is truly safe to eat. Unlike conventional meat production, cultivated meat is produced in controlled laboratory and manufacturing settings. This enables a high degree of containment, process control, and a sterile setting that significantly reduces the risk of contamination. The production process draws from sterile techniques used in pharmaceutical and biotechnology industries and avoids many of the safety challenges inherent in traditional animal farming.
Most cultivated meat producers are developing fully antibiotic-free production systems, and the first products of this kind have already received regulatory approval. This represents a major step forward, not only in consumer health protection, but also in the global effort to combat antimicrobial resistance. For food safety authorities, the key challenge is to create responsive and science-based frameworks for assessing these novel products. As cultivated meat production methods can vary widely, regulations must remain flexible enough to accommodate innovation while ensuring that the final products entering the market are consistently safe. Importantly, many of the potential risks associated with cultivated meat production, such as microbial contamination or chemical residues, are not unique to cultivated meat. They are well-known from conventional food production, and well-established strategies already exist to detect and manage them. A comprehensive overview of possible hazards and their mitigation has been published by the Food and Agriculture Organization (FAO) in their 2023 report on cultivated meat safety.
Biological contamination in cultivated meat production
All food production systems, including both conventional and cultivated meat, must ensure high standards of hygiene and biological safety. Contamination by bacteria, viruses, fungi, parasites, or prions can threaten public health and product integrity. Cultivated meat offers several inherent advantages, however, certain risks remain and must be systematically addressed. Each production facility must map out and monitor potential points of microbial entry, which may differ depending on the specific bioprocess used. Hazard Analysis and Critical Control Points (HACCP) methodologies are widely applied to identify risks and establish appropriate safety checkpoints. Typically, contamination vectors in cultivated meat production fall into three categories: the cell lines themselves, media and other consumable inputs, and environmental factors including equipment, personnel, and facility cleanliness.
In cultivated meat production, the starting material is a small sample of cells obtained from a donor animal. The health status of this animal plays a critical role in ensuring the overall safety of the final product. Just as in conventional meat production, the presence of microbial contaminants, viruses, or parasites in the source tissue must be rigorously assessed. The inspection of donor animals and their tissues is a key safety checkpoint. Regulatory frameworks typically require that the health status of animals used as cell sources is verified, either through veterinary supervision during tissue collection or appropriate documentation. In addition, ongoing cell line screening ensures that pathogens, including bacteria, zoonotic viruses and prions, are absent. Overall, the risk of pathogen transmission from donor animals in cultivated meat production is considerably low. This is largely due to the opportunity for early intervention, targeted tissue selection, and the inherent advantages of producing food in a clean and controlled environment.
The cultivation medium serves as the nutrient source for growing cells and is one of the most important inputs in cultivated meat production. It typically consists of a carefully balanced mixture of salts, sugars, vitamins, amino acids, and organic acids, along with signaling molecules such as growth factors and, in some cases, hormones and antibiotics. The exact formulation can vary depending on the cell type and production stage. Ensuring the safety of the medium is therefore essential, as any contaminants present may directly affect the final product. Historically, many biotechnological processes have relied on fetal bovine serum (FBS) as a supplement in cell cultivation due to its rich, albeit poorly defined, composition. FBS contains thousands of components that support cell growth, but it also presents several safety concerns. These include batch-to-batch variability and the potential presence of a wide range of contaminants, such as viruses, prions, and endotoxins. Studies have shown that between 20–50% of FBS samples may carry viral agents, including bovine viral diarrhea virus, reovirus 3, rabies virus, bluetongue virus, bovine adenovirus, parvovirus, and respiratory syncytial virus. Additionally, there is a theoretical risk of prion contamination, particularly due to cross-species transmissibility via blood-derived products. In response to these concerns, the cultivated meat industry is rapidly transitioning toward serum-free media. These formulations offer significantly greater control over ingredients and enable thorough safety testing of individual components. Serum-free media not only enhance reproducibility but also reduce the risk of animal-derived contamination, aligning with both ethical considerations and food safety priorities.
Beyond biological materials and media components, another critical dimension of food safety in cultivated meat production lies in the potential introduction of contaminants through human handling, equipment, and the surrounding environment. These sources, though well recognized in conventional food manufacturing, require special attention due to the sterility and sensitivity of the cultivated meat process. Personnel involved in the cultivation process can introduce biological hazards through inadequate hygiene practices or unintentional cross-contamination. Skin flora, respiratory emissions, or contaminated clothing can serve as vectors for bacteria, fungi, or viruses. In particular, bioaerosols, airborne particles containing viable biological agents, pose a notable risk in open or semi-open systems, especially during media preparation, cell harvesting, or product handling stages. In parallel, equipment and utensils used throughout the process must meet stringent cleanliness standards. Surfaces and tools can become sites for biofilm formation, communities of microorganisms that adhere to surfaces and are notoriously difficult to remove. If not adequately sanitized, these biofilms can serve as persistent sources of contamination and may compromise multiple batches before being detected. Environmental factors, including air quality, humidity, and temperature, also play a role in maintaining safety. In poorly controlled settings, airborne spores or particulates may enter the production system and jeopardize sterility. To prevent this, cultivated meat facilities often implement cleanroom standards or utilize closed bioreactor systems that isolate the internal environment from external influences. Bioreactors are especially well-suited to mitigate these risks. As closed systems, they significantly reduce the opportunity for contamination from external sources. However, maintaining a sterile environment remains critical. Rigorous controls on purity, cleanliness, and monitoring are essential to ensuring that cultivated meat is consistently safe for consumption. Given the sensitivity of cell cultures to contamination, even minor breaches in protocol can render entire batches unusable. Therefore, robust standard operating procedures, employee training, routine environmental monitoring, and equipment validation are essential elements of any safety strategy.
Traditional meat is particularly prone to microbial contamination, as animals naturally harbor bacteria such as Salmonella, Listeria, Campylobacter, Mycoplasma, and Escherichia coli. These microbes are commonly found on the animal’s skin, in the digestive tract, or in feces. Even with careful handling, contamination can occur at various stages of processing as reported in a number of studies. Martínez-Chávez et al. (2015) found Salmonella on 18% of beef carcasses and 71% of ground beef samples, while E. coli was present on 97% of beef carcasses and in 100% of ground beef samples. Cultivated meat, in contrast, is produced in a closed and controlled environment (bioreactor), limiting exposure to external contaminants. If microbial contamination were to occur, such as the accidental introduction of bacteria, it would quickly overwhelm the cell cultivation and halt the process, serving as an early warning mechanism. The exception is Mycoplasma bacteria, which grow very slowly during cultivation. Due to their small size and resistance to many antibiotics, they represent a unique challenge. While oral infection risk is negligible (no cases have been reported to date), recommended testing protocols are available through Good Cell Culture Practices (GCCP).
Unlike bacteria, viruses can’t reproduce without living cells, contaminated food remains unchanged in taste, smell, and appearance. There are two main routes through which viruses can enter food. The first is known as clinical contamination, where the virus is present in the animal and the product derived from that animal is consumed without sufficient inactivation, typically due to no or inadequate heat treatment (e.g., hepatitis E virus). However, this pathway is relatively uncommon. More frequently, contamination occurs via the so-called environmental route, where the food comes into contact with a contaminated environment after processing (e.g., hepatitis A virus, norovirus). In cultivated meat, viruses could theoretically enter through donor cells or ingredients used in the growth medium. Although cultivated systems are inherently more resistant to viral contamination, precautionary measures are still essential.
Fungal contamination, such as yeasts or molds, poses a different type of threat. Traditional meat products can be subject to fungal contamination via several pathways: the introduction of contaminated spices or raw materials during processing; the growth of toxin-producing molds on the surface of dry-cured meats; and the transfer of contaminants from farm animals exposed to polluted feed. These organisms can produce toxic compounds known as mycotoxins, which may persist in raw meat and processed products, and potentially accumulate in the human body. The most important mycotoxins in connection with meat products are aflatoxin B1 and ochratoxin A (produced mostly by Aspergillus and Penicillium). Citrinin, cyclopiazonic acid and sterigmatocystin can also be present, but their effect on meat products quality and safety of products, and therefore on health of consumers, has still not been fully explored. However, the presence of such fungi would likely suppress the growth of animal cells and thereby serve as an early indicator of contamination, prompting rapid detection and intervention.
Zoonotic foodborne parasites are often characterized by complex life cycles involving multiple hosts, with various developmental stages occurring both within hosts and in the environment. According to FAO (2021), parasites commonly associated with conventional foodborne transmission include Taenia solium from pigs, Toxoplasma gondii from ruminants and pigs, Trichinella species from pigs and wild game, Opisthorchiidae from fish, and Paragonimus from crustaceans. While traditional meat carries a well-documented risk of parasitic transmission, cell-based production offers enhanced opportunities for risk control. Since cultivated meat uses isolated cells, parasitic contamination is virtually eliminated provided that donor tissue is carefully screened.
Prions are proteins with the unusual ability to fold into different structural forms. A particular isoform, rich in beta-sheet structures, has the potential to aggregate into amyloid, which can be harmful. Pathogenic prions have been identified as the cause of fatal neurodegenerative disorders affecting both humans and animals. In certain cases, these diseases exhibit infectious properties and are therefore classified as transmissible spongiform encephalopathies. Creutzfeldt-Jakob disease and kuru were the first infectious prion diseases to be identified in humans. Their presence is tied primarily to nervous and lymphatic tissues, which are not used in cultivated meat production. Moreover, prions cannot replicate in vitro. Validated sourcing and strict screening of inputs help eliminate any risk.
Other concerns in cultivated meat production
Antibiotics are sometimes used in the early stages of cell cultivation to prevent bacterial contamination; however, their inclusion in the cultivated meat production process is increasingly avoided. While antibiotics have long been a staple in conventional animal farming, used both therapeutically and as growth promoters in some regions, their use has raised significant public health concerns. These include the development of antimicrobial resistance (AMR), drug residues in food, hypersensitivity reactions, and other allergic responses in susceptible individuals. In contrast, many cultivated meat producers are actively developing and scaling antibiotic-free production systems. As mentioned above, cultivation takes place in carefully controlled, sterile environments, often within closed bioreactor systems, which drastically reduces the risk of microbial contamination and thereby minimizes the need for antimicrobial agents. Instead of relying on antibiotics, producers adopt rigorous cleanliness protocols, quality control systems, and real-time monitoring to maintain aseptic conditions throughout the cultivation process. This shift away from antibiotics not only aligns with global efforts to combat AMR but also enhances the safety profile of cultivated meat products. By eliminating the potential for residual antibiotics and resistant pathogens in the final product, antibiotic-free cultivated meat offers a reassuring alternative to consumers concerned about the long-term health implications of conventional meat production.
Furthermore, the inclusion of specific bioactive molecules, such as growth factors, requires additional scrutiny. While these substances are essential for directing cell development and proliferation, their use in food production is regulated differently across markets. For example, the European Union prohibits the use of certain growth-promoting agents with hormonal or thyrostatic effects in livestock farming. A similar level of oversight will likely be applied to cultivated meat, underscoring the need for transparent and safe media formulations. In conclusion, the composition and sourcing of the cultivation medium represent a pivotal safety consideration in cultivated meat production. Continued innovation in serum-free, defined media is key to ensuring high safety standards and consumer confidence.
Cryoprotectants are substances used to protect cells from damage during freezing and thawing, a critical step in the preservation and storage of cell lines. Some commonly used cryoprotectants, such as dimethyl sulfoxide (DMSO) or glycerol, have known toxic effects at higher concentrations. However, several of these substances are already approved for use in conventional food processing and have been demonstrated to be safe when used within established limits. In the context of cultivated meat production, cryoprotectants are typically applied during early stages, such as cell banking, and are thoroughly removed or diluted in subsequent steps. The cultivation process includes multiple phases of washing and media exchange, which ensures that any residual cryoprotectants are present in extremely low concentrations, far below thresholds considered harmful. Proper handling and validated purification steps help minimize any potential risk, supporting the safety of the final product. With careful monitoring and adherence to best practices, the use of cryoprotectants in cultivated meat production can be managed effectively without compromising consumer safety.
Safety management in cultivated meat production
To ensure the highest level of safety, cultivated meat production relies on a comprehensive set of preventive and monitoring practices adapted from both the food and pharmaceutical industries. These methods are designed to minimize the risk of contamination and ensure consistent product quality. One of the most fundamental frameworks is Good Manufacturing Practices (GMP), which are widely applied across food processing sectors. GMP includes guidelines for appropriate facility design, sanitary operations, equipment maintenance, and the implementation of process controls to prevent the introduction or spread of hazards. These principles form the backbone of safe food production systems, and their application is equally essential in the context of cultivated meat. Good Hygiene Practices (GHPs) complement GMP by establishing clear protocols for personal hygiene, cleaning procedures, and environmental monitoring. These practices are foundational in the broader food supply chain and are directly applicable to cellular agriculture facilities, particularly those operating under sterile or near-sterile conditions. Additionally, Good Cell Culture Practices (GCCP), a standard framework typically used in biomedical research and pharmaceutical production, offer valuable guidance for handling animal cell cultures. These practices emphasize contamination prevention, regular monitoring, and proper documentation, making them well suited for adaptation to food-grade bioprocesses.
Codes of hygienic practices already exist for traditional animal food production and can be adapted to reflect the unique characteristics of cultivated meat. These codes cover aspects such as health management of donor animals, disease prevention strategies, and safe sourcing of biological inputs. Effective control of all input materials and equipment is also a key pillar of safety. Rigorous testing and validation are required to confirm the safety of media components, cell lines, and bioreactor systems. Finally, a robust system of observation and regular screening is used to detect potential contaminants in cultures, media, and production environments. This includes routine microbiological testing and environmental monitoring to uphold high safety standards throughout the production lifecycle.
The assurance of food safety is a fundamental requirement for any food entering the market. For cultivated meat, safety is evaluated using established approaches to testing ingredients, additives, and potential contaminants, many of which are already harmonized and recognized internationally. Organizations such as the Organisation for Economic Co-operation and Development (OECD), World Health Organization (WHO), and Food and Agriculture Organization (FAO), along with national regulatory bodies, provide comprehensive guidelines for safety assessment.
One of the most important aspects of contamination prevention lies in sterilization (e. g., of cultivated medium, equipment, and cultivated meat after harvesting). Several sterilization techniques commonly used in the food industry are employed, including filtration, irradiation, pulsed electric fields, pasteurization, and high-temperature treatment. Each sterilization method varies in its ability to neutralize different types of microorganisms or contaminants, and their appropriateness depends on the composition of the medium and the sensitivity of the cells. However, when applied properly, these methods significantly reduce the risk of introducing bacteria, fungi, viruses, or other harmful agents into the production process.
Furthermore, toxicity testing plays a key role in the safety validation of cultivated meat. This includes the assessment of media components, processing inputs, and any residues, byproducts, or metabolites that may remain in the final product. The goal is to ensure that none of these substances pose a risk to human health at the levels found in the final food product. As cultivated meat production matures, regulatory agencies are expected to establish clear guidance on testing protocols, drawing from both food safety and pharmaceutical standards.
To ensure the safety of cultivated meat, rigorous microbiological monitoring is a fundamental part of the production process. Bacterial and viral contamination can be detected through continuous process monitoring, with indicators such as physiological changes in the cultivation, pH fluctuations, or shifts in turbidity serving as early warning signs. In addition, standard microbial testing protocols, including screening for pathogens such as Salmonella, Listeria and Escherichia coli, are commonly applied across the industry. Most companies implement routine screening procedures to exclude microbial contamination at all stages of the process. According to a recent survey by Harsini & Swartz (2024), batch failure rates due to contamination in cultivated meat production range from 2–5% in three companies, 5–10% in two others, with only one company reporting more than 10%. For comparison, the commercial biopharmaceutical sector experienced a contamination failure rate of approximately 3.2% in 2022, highlighting that cultivated meat producers are already operating within similar safety parameters. As the industry continues to mature, standardization of production processes, consistent sourcing of inputs, enhanced personnel training, and predictive microbiological models are expected to contribute to further reductions in contamination rates. Protocols to prevent biofilm formation and the integration of advanced pathogen detection technologies will further enhance microbial control. Beyond detection and monitoring, companies are also exploring preventive approaches. The use of food-grade antimicrobial agents or small antimicrobial molecules is being actively researched, with the potential to broaden the range of available tools for contamination prevention in future production systems. Importantly, the FDA safety dossiers submitted by companies such as UPSIDE Foods and GOOD Meat demonstrated an absence of detectable microorganisms in postproduction product samples. Their testing confirmed no presence of coliforms, E. coli, Campylobacter, mold, or yeast, using aerobic plate counts, underscoring the effectiveness of the hygiene and safety controls already implemented in the sector.
In any food production system, it is critical to assess the potential presence of residual substances, contaminants, and byproducts. Cultivated meat is no exception. Regulatory authorities and producers must ensure that the final product is free from harmful residues that could pose risks to consumers. This includes substances used during cultivation, such as antibiotics, cryoprotectants, or growth factors, as well as any unintended metabolites or environmental contaminants. The World Health Organization (WHO) has published a list of critically important antimicrobials that should be excluded from use in animals due to their essential role in human medicine. Adhering to this guidance helps reduce the risk of antimicrobial resistance and supports the responsible development of safe food products.
A combination of biochemical, molecular, physical, and compositional analyses is also employed. These methods can be used to characterize the physicochemical properties of the final product, assess the proliferation and differentiation potential of the cell lines used, evaluate karyotype stability, and verify cell identity through marker expression. Such testing not only supports quality assurance, but also helps detect any unwanted physicochemical transformations that may occur during production. In addition, compositional analysis is used to determine the presence and levels of macronutrients and micronutrients, bioactive molecules, toxins, or allergenic compounds, offering insight into both the nutritional quality and safety profile of the cultivated meat. This comprehensive characterization enables regulatory agencies and producers to ensure that the product is both safe and suitable for human consumption.
In vitro testing represents a valuable tool in the safety assessment of cultivated meat, offering a more efficient and ethically favorable alternative to animal-based methods. These laboratory-based assays are generally less resource-intensive and can help identify potential hazards early in the development process. Additionally, they can support dose selection for later-stage testing and provide mechanistic insights into how the product interacts with biological systems. Although in vitro methods are often considered non-standard in regulatory frameworks and may not fully replace in vivo studies, they can still be extremely useful, particularly in the context of cytotoxicity screening, in vitro digestibility, microbiome interaction studies, and allergenicity testing. Allergenicity remains a central component of food safety assessments, especially in the context of genetically modified or novel foods, where comparative analysis with conventional counterparts is often applied to identify any new or increased risk.
Despite growing interest in replacing animal testing, in vivo testing remains a regulatory requirement in certain markets, particularly for novel food applications. These tests, commonly conducted in rodents, serve as a baseline study to evaluate potential toxicological effects and to help alleviate consumer safety concerns. While alternative testing models continue to advance, a hybrid approach combining in vitro screening with targeted in vivo studies currently offers the most robust pathway to ensuring the safety of cultivated meat products.
Cultivated meat production offers a unique opportunity to reimagine food safety from the ground up. Its closed, controllable environment reduces many risks, including microbial, parasitic, and chemical hazards. Thanks to rigorous hygiene standards, modern sterilization, and established testing protocols, early data suggest that cultivated meat can meet or even exceed the safety expectations of conventional food systems. While regulatory frameworks continue to evolve, transparency, scientific rigor, and proactive communication will be critical to building trust and ensuring the successful adoption of cultivated meat.
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