Establishing food-safe cell lines and banks for cultivated meat: current status and future directions

Highlights

• •Cell lines and cell banking systems are critical determinants of cultivated meat safety, quality, and reproducibility.
• •Comparative analysis of regulatory dossiers reveals substantial variability in cell line qualification and banking practices.
• •Microbial contamination, adventitious agents, genomic instability, and tumorigenicity are identified as priority safety hazards.
• •The absence of harmonized food-grade standards creates regulatory uncertainty and challenges global commercialization.
• •A risk-based Food-Safe Cell Line and Banking Framework (FSCLBF) is proposed to support future standardization efforts.

Abstract

Cultivated meat has emerged as a promising complement to conventional livestock production, with the potential to contribute to food security, animal welfare, and more sustainable food systems. As the field advances toward commercial-scale manufacturing, ensuring product safety and consistency depends fundamentally on establishing well-characterized, stable, and food-safe cell lines and cell banking systems. Cell lines underpin cultivated meat production and serve as critical control points for hazards, including microbial contamination, adventitious agents, genomic instability, cell misidentification, and tumorigenic transformation. This review examines current scientific knowledge, regulatory developments, and industry practices related to cell line development and cell banking for cultivated meat production. Drawing on publicly available regulatory dossiers from GOOD Meat, UPSIDE Foods, and Vow Group, it systematically compares approaches to donor animal qualification, cell sourcing, adventitious agent testing, genomic stability assessment, tumorigenicity evaluation, and cell bank monitoring. The analysis reveals substantial variability in testing strategies, documentation practices, and safety assessment criteria, highlighting the absence of internationally harmonized food-grade standards for cell line qualification and banking. By integrating evidence from regulatory dossiers, scientific literature, and established biopharmaceutical guidance frameworks, this review identifies microbial contamination, adventitious agents, genomic instability, and tumorigenicity as priority hazards requiring systematic control. To address these challenges, a risk-based Food-Safe Cell Line and Banking Framework (FSCLBF) is proposed to support future standardization efforts. The development of transparent, affordable, and robust approaches for cell line qualification and banking will be essential for strengthening regulatory confidence, enhancing consumer trust, and supporting commercialization.

Introduction

The growing global demand for animal-derived protein, coupled with increasing concerns regarding environmental sustainability, resource efficiency, animal welfare, and food security, has accelerated interest in cultivated meat as an alternative food production system (Chriki et al., 2022). Cultivated meat is produced by expanding animal-derived cells under controlled culture conditions rather than through conventional livestock production (Wu et al., 2026). Although cultivated meat has been proposed as a promising approach to complement future protein supplies, its contribution to sustainable food systems must be evaluated across multiple dimensions, including human health, environmental impact, social acceptance, and economic feasibility. Consequently, ensuring the safety, quality, and reproducibility of cultivated meat products remains a critical prerequisite for successful commercialization and consumer acceptance (Bomkamp et al., 2022).

At the core of cultivated meat production are the cells used to generate edible tissues (Santos et al., 2023). The process typically begins with the isolation of suitable cells from livestock species such as cattle, pigs, poultry, and increasingly aquatic species, including fish and crustaceans. These cells are subsequently expanded and differentiated into muscle, fat, and connective tissues under controlled culture conditions. Unlike conventional meat production, where food safety assessment primarily focuses on animal health and processing environments, the safety of cultivated meat begins at the cellular level. The biological characteristics of the source cells directly influence product composition, manufacturing consistency, production efficiency, and safety (Powell et al., 2025). Therefore, contamination, genetic instability, phenotypic drift, cell misidentification, or undesirable cellular transformation may compromise both product integrity and consumer confidence.

To ensure consistency and traceability across production cycles, cultivated meat manufacturers employ cell banking systems consisting of Master Cell Banks (MCBs) and Working Cell Banks (WCBs) (Bennie et al., 2025). The MCB serves as the primary, thoroughly characterized cell repository, while the WCB provides standardized production stocks for routine manufacturing. This hierarchical banking approach minimizes biological variability and supports reproducible production. Similar strategies have long been employed in the biopharmaceutical industry under Good Manufacturing Practices (GMP) and International Council for Harmonization (ICH) guidelines. However, cultivated meat differs fundamentally from pharmaceutical products in terms of production scale, economic constraints, regulatory objectives, and consumer exposure. Consequently, no globally harmonized standards currently exist for cell line qualification, characterization, genetic stability assessment, or long-term cell banking in food applications.

Recent regulatory and scientific developments have highlighted the importance of risk-based approaches for evaluating hazards associated with cultivated meat production. The joint FAO/WHO report on Food Safety Aspects of Cell-Based Food emphasized that safety evaluation should begin at the earliest stages of production, particularly during cell sourcing, cell line development, and cell banking (World Health Organization, 2023). Potential hazards include microbial contamination, adventitious agents, genetic and epigenetic instability, chemical residues, cryoprotectant carryover, cross-species contamination, and tumorigenic transformation of immortalized cells. These hazards require systematic identification, monitoring, and mitigation using scientifically validated approaches to ensure consumer safety and regulatory confidence.

The current lack of harmonized standards is evident in publicly available regulatory dossiers submitted by cultivated meat developers. Companies such as GOOD Meat, UPSIDE Foods, and Vow Group have disclosed varying approaches to donor animal qualification, microbial and viral testing, cell identity verification, genetic stability assessment, and cell banking practices as part of submissions to regulatory authorities including the U.S. Food and Drug Administration (FDA), the Singapore Food Agency (SFA), and Food Standards Australia New Zealand (FSANZ) (Stevens and Ruperti, 2024; Bennie et al., 2025). Comparative analysis of these dossiers reveals substantial variability in testing strategies, documentation requirements, and safety evaluation criteria. Such differences highlight the absence of internationally accepted standards for food-grade cell line qualification and banking and underscore the need for more consistent risk-based approaches across the cultivated meat sector.

Several recent reviews have discussed cultivated meat production technologies, regulatory developments, sustainability considerations, and general food safety challenges (Bakhsh et al., 2025; Powell et al., 2025). However, comparatively limited attention has been given specifically to cell line qualification and cell banking as foundational determinants of cultivated meat safety, quality, and regulatory acceptance. Furthermore, no previous review has systematically compared publicly available regulatory dossiers from leading cultivated meat companies while integrating industry practices, regulatory expectations, and risk management principles into a dedicated framework for food-safe cell line development and banking.

Therefore, this review aims to synthesize current knowledge and practices related to cell line development and cell banking for cultivated meat production, critically evaluate existing safety and regulatory gaps, and identify priorities for future harmonization. Specifically, this review examines: (i) the biological and safety considerations associated with cell line establishment; (ii) the role of cell banking in ensuring traceability, reproducibility, and product consistency; (iii) current quality control practices reported by leading cultivated meat companies; and (iv) the need for standardized, risk-based frameworks to support food-safe cell line qualification and banking. By focusing on the intersection of cell biology, food safety, and regulatory science, this review seeks to provide a practical foundation for the development of globally harmonized approaches that can support the safe, scalable, and sustainable growth of the cultivated meat industry.

The role of cell lines in cultivated meat production

Cell lines serve as the biological foundation of cultivated meat production, determining the growth kinetics, differentiation potential, nutritional composition, and overall quality of the final product (Gomez Romero and Boyle, 2023). In contrast to conventional meat, which derives from heterogeneous tissues composed of multiple cell types, cultivated meat relies on a reproducible, controlled population of cells that can proliferate and differentiate efficiently in vitro. The successful establishment of such cell lines requires integrating principles from developmental biology, tissue engineering, and food biotechnology (Fig. 1).

Fig. 1.

Role of cell lines in cultivated meat production. The figure illustrates the progression from donor animal sourcing and cell line establishment to cell banking and large-scale cultivation, highlighting major biological hazards and the associated quality control measures required to ensure product safety, stability, and traceability.

Cell line selection and origin

Selecting an appropriate cellular source is one of the most critical decisions in cultivated meat production because it directly influences proliferation capacity, differentiation efficiency, product composition, scalability, and regulatory acceptance (Kirsch et al., 2023). Cell-based meat production can be initiated using several types of animal-derived cells, including primary cells, cell strains, and immortalized cell lines. Although these terms are often used interchangeably, they represent biologically distinct cell populations with different advantages and limitations.

Primary cells are directly isolated from tissues obtained through minimally invasive biopsies or donor animal sampling and are commonly derived from skeletal muscle, adipose tissue, or connective tissue. Muscle satellite cells and mesenchymal stem cells (MSCs) are among the most extensively studied cell types because of their ability to proliferate and differentiate into muscle fibers and adipocytes. However, primary cells possess a finite lifespan and undergo replicative senescence after a limited number of passages, restricting their long-term suitability for large-scale manufacturing.

To overcome this limitation, some developers establish cell strains or immortalized cell lines capable of extended or continuous proliferation. Cell strains are selected cell populations that exhibit enhanced growth characteristics while still maintaining a finite lifespan. In contrast, immortalized cell lines acquire the capacity for indefinite proliferation through spontaneous immortalization or targeted biological interventions. Immortalization may occur naturally or be induced through mechanisms such as telomerase reverse transcriptase (TERT) overexpression or modification of cell-cycle regulatory pathways involving genes such as p53 and RB1 (Sutyagina et al., 2023).

Immortalized cell lines are increasingly viewed as attractive production platforms because they reduce the need for repeated animal sampling and facilitate consistent large-scale manufacturing. For example, Pasitka et al. (2023) reported the spontaneous immortalization of chicken fibroblasts through constitutive expression of endogenous chicken TERT, generating stable cell lines suitable for cultivated meat applications. Similarly, publicly available regulatory dossiers indicate that cultivated meat developers, including UPSIDE Foods, GOOD Meat, and Vow Group, employ various combinations of primary, spontaneously immortalized, or proprietary cell lines depending on their production strategies (Bennie et al., 2025).

In addition to terrestrial livestock species such as cattle (Bos taurus), pigs (Sus scrofa domesticus), and chickens (Gallus gallus), increasing attention is being directed toward aquatic species, including salmon, tuna, shrimp, and other seafood organisms. These species offer unique opportunities for cultivated seafood production. However, they may require species-specific approaches for cell isolation, culture optimization, and biosafety evaluation, given differences in physiology, growth temperature, and susceptibility to aquatic pathogens.

Despite their technological advantages, immortalized cell lines remain one of the most debated aspects of cultivated meat production. Regulatory agencies, scientists, and consumers have raised questions about genomic stability, traceability, and the potential tumorigenicity of continuously proliferating cells. Importantly, the presence of an immortalized cell line does not necessarily imply a direct consumer health risk; however, it necessitates rigorous characterization, genomic monitoring, and safety assessment to ensure that cell populations remain stable, authentic, and suitable for food production throughout prolonged manufacturing cycles.

Functional and phenotypic characterization

Once established, cell lines must be characterized for their identity, purity, stability, and performance. Identity verification ensures that cells originate from the intended species and tissue type, often achieved through molecular markers such as cytochrome oxidase I (COI) sequencing, polymerase chain reaction (PCR)-based genotyping, or enzyme-linked immunosorbent assays (ELISA). Purity testing is essential to confirm the absence of cross-species or microbial contamination, while stability assessments track potential genetic drift or phenotypic alterations over time.

Moreover, cell lines must demonstrate the capacity for scalable proliferation in serum-free or defined culture media, differentiation into target tissues (muscle, fat, connective tissue), and nutritional equivalence to conventional meat. Performance metrics such as cell doubling time, biomass yield, protein content, and metabolite secretion are key indicators for industrial feasibility. The combination of these tests ensures that the cell line remains robust and predictable under manufacturing conditions.

Safety and regulatory considerations

From a food safety perspective, cell lines can pose biological and chemical hazards (Weiskirchen et al., 2023). These include adventitious agents (viruses, mycoplasma, bacteria, fungi), genetic instability leading to oncogenic mutations, and residual process materials from genetic modification or cryopreservation. Regulatory authorities such as the FDA, the Singapore Food Agency (SFA), and Food Standards Australia New Zealand (FSANZ) have begun reviewing cell line dossiers for cultivated meat products. However, no unified international guidelines currently exist for assessing these risks.

For instance, the GOOD Meat dossier reported over 40 viral tests, while UPSIDE Foods conducted three broad virus panels without species-specific detail, and Vow performed only four viral assays (Bennie et al., 2025). This variability underscores the lack of standardized testing requirements for cultivated meat cell lines. A harmonized, risk-based framework—similar to that used in biopharmaceutical manufacturing—would enable more consistent and transparent safety evaluations. The Food and Agriculture Organization (FAO) has recently emphasized that safety assessments should begin at the cellular level, incorporating both pre-market and post-market monitoring to ensure consumer protection over time.

Toward food-grade cell lines

The transition from laboratory-grade to food-grade cell lines represents a significant technological and regulatory milestone. Food-grade lines must be free from antibiotic dependence, genetically stable over long passages, and able to grow in cost-effective, serum-free media that exclude animal-derived components (Bakhsh et al., 2025). Furthermore, the long-term use of such lines requires robust traceability, cryopreservation, and documentation to meet regulatory scrutiny and public expectations for food transparency.

Developing dedicated, food-safe cell lines tailored for cultivated meat applications will allow the industry to move away from reliance on biomedical or research cell lines, which may not meet food safety requirements. Initiatives focusing on open-source, non-proprietary cell lines could also accelerate global innovation while ensuring safety and standardization across companies and regions.

Food safety risks associated with cell lines

The use of cell lines as the biological foundation of cultivated meat production introduces distinct food safety considerations that differ substantially from those encountered in conventional livestock systems. In traditional meat production, food safety relies heavily on animal health management, veterinary inspection, and post-harvest control measures. In contrast, cultivated meat safety begins at the cellular level, where the identity, stability, purity, and performance of the starting cell population directly influence the safety and quality of the final product. Because cultivated meat is generated through extensive cellular proliferation, any contamination, genetic alteration, or loss of cell identity occurring during early stages of production may be amplified throughout downstream manufacturing processes. Consequently, robust safety evaluation of cell lines is increasingly recognized as a critical component of cultivated meat risk assessment (World Health Organization, 2023).

Microbial contamination and adventitious agents

Microbial contamination remains one of the most significant biological hazards associated with cultivated meat production. Cell culture systems provide nutrient-rich environments that support not only cellular growth but also the proliferation of bacteria, fungi, yeasts, mycoplasma, and viruses. Contamination can occur during donor tissue collection, cell isolation, routine cell culture operations, banking procedures, or large-scale bioreactor cultivation. Even low-level contamination may alter cellular metabolism, interfere with protein synthesis, reduce product quality, and generate potentially harmful metabolites.

Among microbial hazards, mycoplasma contamination is particularly problematic because it often remains undetected without specialized testing, yet significantly affects cell physiology and genetic stability. Similarly, adventitious viral agents pose a major regulatory concern because some viruses may persist in cell cultures without causing obvious cytopathic effects. The FAO/WHO expert consultation on cell-based foods identified microbial contamination and adventitious agents as priority hazards requiring systematic monitoring throughout production (World Health Organization, 2023). Consequently, routine microbial surveillance, validated detection methods, and strict aseptic procedures are essential components of cultivated meat safety management systems.

Genetic and phenotypic instability

The long-term expansion of cells during cultivated meat production creates opportunities for genetic and phenotypic changes to accumulate. Repeated passaging may result in chromosomal abnormalities, single-nucleotide variants, epigenetic modifications, or alterations in gene expression profiles (Jaime-Rodríguez et al., 2023). Such changes may influence cellular growth characteristics, differentiation capacity, nutritional composition, and production consistency.

Although some biological variation is expected during prolonged cultivation, excessive genomic instability may compromise manufacturing reliability and raise regulatory concerns about the predictability of the final product. Current approaches for monitoring stability include karyotype analysis, whole-genome sequencing, transcriptomic profiling, and phenotypic performance assessments. However, unlike the biopharmaceutical sector, cultivated meat currently lacks internationally accepted criteria defining acceptable levels of genomic variation, testing frequency, or passage limits for food-grade cell lines. Establishing such criteria represents an important priority for future regulatory harmonization.

Chemical residues and process-related hazards

Chemical hazards may arise from culture media components, cryopreservation agents, scaffolding materials, and other processing aids used during cultivated meat production (Post et al., 2020). Historically, some cell culture systems relied on animal-derived materials, such as fetal bovine serum, raising concerns about pathogen transmission, allergenicity, and batch-to-batch variability. Although the industry is increasingly transitioning to serum-free, chemically defined media, other potential hazards remain.

Cryoprotectants such as dimethyl sulfoxide (DMSO), commonly used during cell banking procedures, may persist in thawed cell populations if not adequately removed. Likewise, biomaterials used in scaffolds, microcarriers, or bioinks may release degradation products that require toxicological evaluation before use in food. Therefore, a comprehensive assessment of process-related residues and material safety is essential to ensure that cultivated meat products meet food safety expectations and regulatory requirements.

Cell identity and cross-species contamination

Maintaining cell identity throughout cultivation and banking is essential for product authenticity, traceability, and consumer confidence. In facilities handling multiple species or cell types, accidental cross-contamination may occur through shared equipment, operator error, aerosols, or inadequate segregation procedures (Moloney et al., 2023). Such events may compromise product labeling, create regulatory challenges, and undermine consumer trust.

To address these risks, molecular authentication tools, including mitochondrial DNA sequencing, cytochrome oxidase I (COI) analysis, and species-specific polymerase chain reaction (PCR) assays, are increasingly employed to verify cell identity. Nevertheless, substantial variation currently exists among developers regarding testing frequency and acceptance criteria. Standardized authentication protocols for master and working cell banks would improve traceability and strengthen confidence in cultivated meat supply chains. In addition to molecular approaches, spectroscopic techniques combined with machine learning have emerged as rapid, non-destructive tools for the authentication and classification of biological materials in food systems (Mia and Hashem, 2026; Mia et al., 2025).

Tumorigenicity: Scientific and regulatory perspectives

Tumorigenicity is arguably one of the most sensitive and widely debated safety issues associated with cultivated meat, particularly because many commercial production strategies rely on immortalized or continuously proliferating cell lines. Immortalization may occur through spontaneous biological processes or through modifications involving pathways associated with cellular senescence and proliferation, including telomerase activation and alterations in cell-cycle regulatory mechanisms (Sutyagina et al., 2023). Consequently, concerns have been raised regarding whether immortalized cells could pose risks to consumers.

Importantly, the tumorigenic potential of a cell line should be distinguished from the potential risk associated with consuming cultivated meat products. Tumor formation is a complex biological process that requires living cells capable of surviving, proliferating, and interacting with host tissues under highly specific physiological conditions. Current scientific understanding suggests that consuming processed, digested cultivated meat does not present the same biological risks as cellular transplantation or therapeutic applications. Therefore, the presence of an immortalized cell line does not automatically imply a direct cancer risk to consumers.

Nevertheless, tumorigenicity remains an important regulatory and quality-control consideration because it serves as an indicator of broader genomic stability and cellular behavior. Current industry approaches differ considerably. GOOD Meat reported both in vitro and in vivo tumorigenicity assessments, whereas UPSIDE Foods and Vow Group primarily relied on genomic stability evaluations and molecular analyses (Bennie et al., 2025). This divergence reflects the absence of consensus regarding the most appropriate methods for evaluating tumorigenic risk in food applications. Future regulatory frameworks would benefit from harmonized guidance clarifying whether direct functional assays, genomic analyses, or integrated approaches are most appropriate for cultivated meat safety assessment.

Regulatory challenges and knowledge gaps

Despite increasing regulatory attention, there remains no internationally harmonized framework defining minimum safety requirements for cultivated meat cell lines and cell banks. Existing regulatory approaches vary substantially among jurisdictions, creating uncertainty regarding required testing strategies, acceptable risk thresholds, and documentation expectations. As demonstrated by publicly available cultivated meat dossiers, substantial differences exist in microbial screening, viral testing, genomic stability assessment, tumorigenicity evaluation, and traceability practices.

These inconsistencies highlight the need for risk-based, internationally coordinated safety frameworks that define minimum testing requirements, monitoring frequencies, and acceptance criteria for food-grade cell lines. Such harmonization would facilitate regulatory consistency, improve scientific reproducibility, strengthen consumer confidence, and support the responsible commercialization of cultivated meat products worldwide.

Importance of cell banking

Cell banking is a fundamental component of quality assurance, biosafety, and process standardization in cultivated meat production (Weiskirchen et al., 2024). It provides a structured system for preserving, tracking, and reproducing cell lines over extended periods while minimizing the risks of contamination, genetic drift, phenotypic variation, and loss of cell identity. Drawing on established principles from biotechnology and biopharmaceutical manufacturing, an effective cell banking strategy enables the production of cultivated meat that is safe, consistent, traceable, and reproducible at an industrial scale.

The standard approach in biotechnology relies on a two-tier banking system consisting of a Master Cell Bank (MCB) and a Working Cell Bank (WCB). The MCB represents the original, thoroughly characterized, and authenticated cell population derived from a selected cell source or clone (Tharmalingam et al., 2018). This bank serves as the primary reference material for all future production activities. Before long-term cryogenic storage, MCB stocks are typically evaluated for cell identity, viability, genetic stability, and the absence of microbial and adventitious contaminants. A WCB is subsequently generated from the MCB and provides the routine production stock used in manufacturing operations. By limiting repeated expansion from the original cell source, this hierarchical structure helps preserve cellular characteristics and reduces the risk of cumulative biological changes over time. Together, the MCB and WCB provide a reliable foundation for maintaining consistency across production batches while ensuring traceability throughout the manufacturing process.

Properly maintained cell banks offer several important advantages for cultivated meat safety and quality assurance. First, they support traceability by linking each production batch to a documented, characterized cell source. This capability is essential for regulatory oversight, product recall procedures, post-market monitoring, and root-cause investigations in the event of safety concerns. Second, cryogenic preservation minimizes cellular alterations during storage and reduces the likelihood of genetic or epigenetic drift that could affect growth characteristics, differentiation potential, or product composition. Third, the reproducibility of product attributes such as protein content, lipid composition, texture, and sensory characteristics depends on maintaining stable, consistent cell populations, which is facilitated by robust banking practices.

Despite these benefits, cell banking also introduces several challenges that require careful management. One of the most important concerns is cell misidentification or cross-contamination. Historical experience from biomedical research has demonstrated that cell line misidentification and contamination remain persistent challenges, highlighting the importance of routine authentication practices. In cultivated meat production, where cells constitute the edible product itself, such errors may compromise product labeling, species authenticity, regulatory compliance, and consumer trust. Consequently, routine identity verification using molecular approaches such as mitochondrial DNA sequencing, cytochrome oxidase I (COI) analysis, or species-specific polymerase chain reaction (PCR) assays is essential. In addition, viability testing is required to confirm that cryopreserved cells retain adequate growth and differentiation capacity after thawing. In contrast, adventitious-agent testing helps ensure the absence of bacteria, fungi, mycoplasmas, and viral contaminants that could compromise food safety.

To establish robust quality control systems, the cultivated meat industry can draw upon principles developed by the biopharmaceutical sector, including guidance from the World Health Organization (WHO), the International Council for Harmonization (ICH Q5D), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) (Ong et al., 2021). These frameworks emphasize documentation, traceability, stability assessment, contamination control, and characterization of biological materials. Although cultivated meat products differ substantially from pharmaceutical products in their intended use, production volume, and economic constraints, the underlying principles of cell authentication, contamination prevention, and process control remain highly relevant. Consequently, biopharmaceutical guidance provides a valuable foundation for the development of food-grade cell banking systems.

However, adopting pharmaceutical-grade standards directly may not be practical for cultivated meat manufacturing. Unlike therapeutic products, cultivated meat must ultimately compete within the economics of food production, where cost efficiency and scalability are critical considerations. Comprehensive analytical procedures such as routine whole-genome sequencing, extensive viral screening panels, and advanced characterization assays can be economically challenging when applied at food-production scales. Therefore, the cultivated meat sector will likely require a food-specific adaptation of existing quality systems, emphasizing risk-based, scalable, and cost-effective testing approaches while maintaining high safety standards. This concept aligns with the emerging idea of Good Food Manufacturing Practices (GFMP), which adapts core GMP principles to the operational realities of food production.

Future progress in cultivated meat manufacturing will also depend on the establishment of shared resources and collaborative quality infrastructures. Recent initiatives, including the Good Food Institute (GFI) open-access cell line project and other efforts promoting food-grade biological repositories, highlight the growing recognition that standardized and well-characterized cell resources are essential for accelerating innovation and improving biosafety across the sector. Such initiatives could reduce duplication of effort, improve transparency, facilitate regulatory review, and support the development of globally harmonized standards for cultivated meat cell banking (Macedo et al., 2024).

Ultimately, effective cell banking serves as a critical bridge between cell line development and commercial-scale production. By preserving cell identity, ensuring traceability, minimizing biological variability, and supporting systematic quality control, cell banking provides the foundation for safe, reproducible, and commercially viable cultivated meat systems.

Current quality control practices and case studies

Establishing robust quality control (QC) systems is essential for ensuring the safety, consistency, and regulatory acceptance of cultivated meat products (de Macedo et al., 2024). Although the cultivated meat industry remains at an early stage of commercialization, publicly available regulatory dossiers from GOOD Meat, UPSIDE Foods, and Vow Group provide valuable insights into current approaches to cell line qualification, cell banking, and safety assessment (Fig. 2). Comparative analysis of these dossiers reveals considerable variation in donor animal qualification, cell sourcing documentation, microbial screening, genomic stability assessment, and tumorigenicity evaluation, reflecting the absence of internationally harmonized standards for food-grade cell line development and banking (Table 1).

Fig. 2.

Schematic overview of food-grade cell line development and banking for cultivated meat. The figure depicts key stages from donor animal sourcing and cell isolation to safety characterization and establishment of master and working cell banks. Quality control measures addressing genetic stability, microbial safety, identity authentication, and tumorigenicity are integrated throughout the process to ensure product safety and consistency, highlighting the need for globally harmonized standards for cultivated meat production.

Table 1.

Comparative overview of safety control depth applied to cell lines and cell banking in cultivated meat dossiers.

Safety control domain	Traditional chicken meat	Cultivated meat dossiers (GOOD Meat, UPSIDE Foods, Vow Group)	Key observations/gaps
Source animal health assurance	Mandatory flock health programs and routine ante- and post-mortem inspection	Variable approaches: limited disclosure (GOOD Meat), general statements of suitability (UPSIDE Foods), or formal veterinary certification (Vow Group)	Absence of harmonized donor animal health documentation requirements for cell sourcing
Cell isolation traceability	Not applicable	Documentation ranges from minimal (GOOD Meat) to detailed records of time, place, protocols, and access control (UPSIDE Foods, Vow Group)	Traceability practices are inconsistent and not standardized
Cell identity verification	Not required	Molecular species verification using PCR or COI sequencing; cross-species contamination testing inconsistently applied	Cell identity control exists but lacks unified acceptance criteria
Viral and mycoplasma safety testing	Not required	Large variability in scope: extensive multi-panel testing (GOOD Meat) vs limited or unspecified panels (UPSIDE Foods, Vow Group)	No consensus on minimum adventitious agent testing requirements
Bacterial and fungal control	Clearly defined regulatory microbiological criteria	Broader and more diverse microbial testing panels applied at the cell and culture level	Cultivated meat relies on proactive culture-based testing rather than end-product inspection
Tumorigenic risk assessment	Not applicable	Direct in vivo or in vitro testing (GOOD Meat) vs indirect genomic inference only (UPSIDE Foods, Vow Group)	No unified regulatory expectation for tumorigenicity assessment
Cell line and bank stability	Not applicable	Stability assessed using growth kinetics, viability, phenotypic performance, or whole-genome sequencing	Stability endpoints and monitoring duration differ substantially
Regulatory maturity	Well-established global frameworks	Company-specific interpretations of novel food or biotechnology guidance	Demonstrates early-stage regulatory fragmentation

Note: This table emphasizes the relative depth and diversity of safety controls applied to cell lines and cell banks in cultivated meat production compared with conventional meat systems. Downstream processing controls are excluded.

Donor animal qualification and cell sourcing

The reviewed dossiers demonstrate notable differences in the level of documentation provided for donor animal qualification and cell sourcing (Wolf et al., 2022). GOOD Meat reported using chicken eggs from commercial suppliers but provided limited publicly available information on donor animal health assessments. UPSIDE Foods stated that donor animals were suitable for human consumption and had undergone veterinary inspection, although detailed supporting documentation was not publicly disclosed. In contrast, Vow Group provided more extensive information, including veterinary certification of donor flock health status and microbiological screening results. These differences illustrate the lack of standardized requirements for donor animal qualification and traceability in cultivated meat regulatory submissions (Table 1).

Cell isolation and documentation practices

Differences were also observed in the extent of documentation associated with cell isolation and cell line establishment (Weiskirchen et al., 2023). Publicly available information indicates that some developers provided only limited descriptions of cell isolation procedures. In contrast, others reported tissue collection conditions, laboratory controls, culture conditions, and biosecurity measures in greater detail. For example, Vow Group described the use of restricted-access laboratory environments and dedicated facilities for quail cell culture operations. Such variability highlights the absence of harmonized reporting standards for cell sourcing and handling procedures, despite their importance for traceability and reproducibility (Table 1).

Adventitious agent testing

One of the most significant areas of divergence among the reviewed dossiers concerns adventitious agent testing (Sophian, 2026). GOOD Meat reported extensive viral screening involving more than 40 assays covering both avian and human viral agents. UPSIDE Foods performed broader virus screening panels targeting multiple species but provided limited detail regarding individual pathogens. Vow Group adopted a more focused testing strategy, focusing on a smaller number of PCR-based viral assays. Similar variation was observed in microbial surveillance programs. While all companies evaluated major foodborne pathogens such as Salmonella, Escherichia coli, and Listeria monocytogenes, the breadth and depth of bacterial and fungal testing differed substantially among developers. These findings indicate a lack of consensus on minimum testing requirements for microbial and viral safety assessment in cultivated meat production (Table 1, Table 2).

Table 2.

Risk-based hazard identification and control measures for cell lines used in cultivated meat production.

Cell line stage	Potential hazard	Risk type	Current mitigation practices (reported)	Identified gaps / needs
Donor animal sourcing	Undetected infectious disease	Biological	Ante- and post-mortem inspection; veterinary certification in selected cases	Lack of standardized donor health documentation and testing requirements
Cell isolation	Microbial contamination	Biological	Aseptic isolation; restricted access facilities (limited cases)	Inconsistent reporting of isolation conditions and biosafety controls
Cell line establishment	Genetic instability	Genetic	Immortalization monitoring; genome integrity analysis	No agreed thresholds for acceptable genetic variation
Cell line expansion	Adventitious viral agents	Biological	PCR-based viral screening panels	Variable test coverage and lack of harmonized virus panels
Cell identity maintenance	Cross-species contamination	Biological / integrity	COI sequencing; PCR-based identity tests	Absence of mandatory identity testing at MCB/WCB level
Cell banking (MCB/WCB)	Phenotypic drift	Genetic	Viability and growth monitoring; limited genomic surveillance	Non-uniform stability endpoints and monitoring duration
Cell banking (MCB/WCB)	Tumorigenic transformation	Biological	In vivo/in vitro assays or indirect genomic inference	No consensus on necessity or methodology of tumorigenicity testing
Long-term storage	Loss of traceability	Systemic	Batch records and documentation	Need for globally accepted traceability and certification systems

Tumorigenicity and stability assessment

Substantial variation was also observed in approaches to assessing tumorigenicity and cell bank stability. GOOD Meat evaluated tumorigenic potential using both in vitro soft agar assays and in vivo studies in adult chickens. In contrast, UPSIDE Foods focused primarily on genomic stability assessment through whole-genome sequencing, whereas Vow Group relied largely on genetic stability monitoring of cell banks and final products. These differing approaches reflect the absence of a harmonized regulatory framework defining appropriate safety endpoints for cultivated meat cell lines.

Differences were similarly evident in stability evaluation strategies. GOOD Meat monitored cell bank stability using viability and doubling-time measurements over 24 months, whereas UPSIDE Foods emphasized growth performance and biomass production. Vow Group combined routine viability monitoring with genomic analyses extending to the final product stage. Although all three companies recognized the importance of stability assessment, substantial differences remain regarding testing methodologies, monitoring duration, and acceptance criteria (Table 1).

Risk prioritization and regulatory implications

Beyond differences in testing methodologies, the reviewed dossiers suggest that individual hazards do not contribute equally to overall risk. Based on publicly available regulatory submissions and published scientific literature, microbial contamination, adventitious viral agents, and genomic instability appear to be the highest-priority concerns due to their direct implications for product safety, manufacturing consistency, and regulatory approval. In contrast, hazards such as cross-species contamination and residual processing materials, while still important, may be more readily managed through established quality assurance procedures. To illustrate the relative importance of these hazards, a qualitative risk prioritization matrix was developed (Table 3).

Table 3.

Qualitative risk prioritization matrix for cell line-associated hazards in cultivated meat production.

Hazard Category	Example Hazard	Probability of Occurrence	Potential Severity	Overall Risk Priority	Primary Impact
Adventitious agents	Viral contamination	High	High	Very High	Consumer safety, regulatory approval
Microbial contamination	Bacteria, fungi, mycoplasma	High	High	Very High	Product safety, production failure
Genetic instability	Chromosomal abnormalities, SNVs, epigenetic drift	Medium	High	High	Product consistency, regulatory compliance
Tumorigenic transformation	Uncontrolled proliferative characteristics	Low–Medium	High	High	Consumer perception, regulatory scrutiny
Cell misidentification	Incorrect cell lineage assignment	Medium	Medium	Medium	Traceability, product authenticity
Cross-species contamination	Interspecies cell mixing	Low–Medium	Medium	Medium	Labeling integrity, consumer trust
Chemical residues	DMSO, scaffold degradation products	Low	Medium	Low–Medium	Toxicological concerns
Loss of cell bank stability	Reduced viability or phenotypic drift	Medium	Medium	Medium	Manufacturing reproducibility
Documentation and traceability failures	Incomplete records	Low	Medium	Low–Medium	Regulatory compliance

Note: Risk rankings are qualitative assessments derived from publicly available cultivated meat regulatory dossiers, FAO/WHO food safety considerations, and published literature. The matrix is intended to illustrate relative hazard prioritization and should not be interpreted as regulatory acceptance criteria. Risk ranking reflects regulatory concern rather than demonstrated consumer hazard.

Collectively, these case studies demonstrate that although cultivated meat developers share common objectives regarding safety, reproducibility, and product quality, substantial variability remains in testing strategies, documentation practices, and quality control approaches. This heterogeneity reflects the absence of internationally harmonized standards for food-grade cell line qualification and banking. Consequently, the findings support the development of risk-based frameworks that establish minimum testing requirements, acceptance criteria, documentation standards, and monitoring frequencies for cultivated meat cell lines and cell banks. Such harmonization would facilitate more consistent regulatory evaluation, improve scientific reproducibility, strengthen consumer confidence, and support the responsible commercialization of cultivated meat products worldwide. These observations provide the rationale for the proposed Food-Safe Cell Line and Banking Framework (FSCLBF) presented in the following section. Importantly, the observed variability among regulatory dossiers highlights the urgent need for harmonized food-grade standards for cell line qualification and banking.

Need for standardized safety and regulatory frameworks

The rapid advancement of cultivated meat technology has outpaced the development of globally harmonized safety and regulatory frameworks governing cell line qualification and cell banking (Fig. 3). Although the scientific foundations of cell culture, cryopreservation, and biological characterization are well established in biomedical and biopharmaceutical sectors, their application to food production remains fragmented and inconsistent. Consequently, regulatory authorities currently rely on different interpretations of safety requirements, resulting in substantial variability in documentation expectations, testing strategies, and approval pathways. As highlighted by the comparative case studies in Section 5, the absence of harmonized standards leads to inconsistent approaches to donor animal qualification, adventitious agent testing, genomic stability monitoring, and tumorigenicity assessment.

Fig. 3.

Need for standardized safety and regulatory frameworks for cultivated meat. The figure highlights how fragmented regulations, inconsistent safety testing, regulatory uncertainty, and consumer distrust arise from the absence of harmonized standards. A centralized, standardized food-safe framework, supported by unified safety requirements, transparent documentation, and international harmonization, is presented as essential for safe, scalable, and trusted cultivated meat production.

The current global regulatory landscape remains highly decentralized. Singapore established the first dedicated regulatory pathway for cultivated meat through the Singapore Food Agency (SFA), which approved cultivated chicken products in 2020 (Johnson and Monaco, 2025). In the United States, regulatory oversight is shared between the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA-FSIS) (Owusu-Apenten and Vieira, 2022), while cultivated meat products in the European Union are expected to be regulated under the Novel Foods Regulation framework (Monaco, 2025; Bellenghi and Knuth, 2024). Similarly, Food Standards Australia New Zealand (FSANZ) has evaluated cultivated meat applications under existing food safety regulations (Powell et al., 2025). In contrast, Israel has relied on adaptations of existing principles for food and biotechnology assessment (Kimhi, 2024). Despite these developments, no jurisdiction has yet established comprehensive technical guidance specifically addressing cell line qualification, cell bank management, genomic stability criteria, or tumorigenicity assessment for cultivated meat production.

The need for harmonization is further supported by the risk prioritization analysis presented in Table 3. Among the hazards associated with cultivated meat production, microbial contamination, adventitious viral agents, genomic instability, and tumorigenicity represent the highest-priority concerns because of their direct implications for food safety, manufacturing reliability, and regulatory approval. In contrast, other hazards, such as cross-species contamination and residual processing materials, may be effectively managed through established quality assurance procedures. These observations emphasize the importance of adopting risk-based regulatory systems that allocate resources and testing requirements according to the relative significance of identified hazards.

Several international initiatives have begun addressing these challenges. The FAO and WHO have convened expert consultations emphasizing that safety assessment should begin at the earliest stages of cell sourcing, cell line establishment, and banking (World Health Organization, 2023). In parallel, the Cultivated Meat Safety Initiative (CMSI), coordinated by New Harvest Foundation and Vireo Advisors, has sought to identify scientific data gaps and promote evidence-based regulatory decision-making (Calhoun et al., 2024). Additional efforts, including the Good Food Institute (GFI) open-access cell line initiatives, highlight growing recognition that standardized biological resources and harmonized quality control approaches will be essential for the long-term development of the cultivated meat sector. Nevertheless, these initiatives remain largely advisory, and globally accepted technical standards have yet to emerge (Macedo et al., 2024).

Proposed food-safe cell line and banking framework (FSCLBF)

To address these challenges, a Food-Safe Cell Line and Banking Framework (FSCLBF) is proposed. The framework is conceptually analogous to the Hazard Analysis and Critical Control Point (HACCP) system used in conventional food safety management. However, it is specifically adapted for cell culture-based food production (Bennie et al., 2025). Unlike existing cultivated meat guidance documents, the FSCLBF focuses specifically on the qualification, monitoring, and maintenance of food-grade cell lines and cell banks (Fig. 4).

Fig. 4.

Schematic representation of the proposed Food-Safe Cell Line and Banking Framework (FSCLBF) for cultivated meat production, illustrating key production stages, safety controls, and expected quality outcomes.

The proposed framework incorporates six critical control points (CCPs): (1) donor animal qualification, (2) cell isolation and authentication, (3) adventitious agent testing, (4) genomic stability and tumorigenicity assessment, (5) cell bank monitoring and contamination control, and (6) periodic requalification of master and working cell banks. Collectively, these control points provide a structured approach for identifying, monitoring, and mitigating biological, genetic, and process-related hazards throughout cell line development and banking.

To improve operational applicability, indicative testing requirements and monitoring frequencies are proposed (Table 4). These recommendations should be considered expert-informed guidance intended to support future standardization efforts rather than regulatory requirements. Additional empirical validation will be required before universally accepted thresholds can be established.

Table 4.

Proposed operational food-safe cell line and banking framework (FSCLBF).

Critical Control Point (CCP)	Minimum Testing Requirement	Indicative Acceptance Criteria	Suggested Monitoring Frequency
Donor animal qualification	Veterinary health screening	No evidence of infectious disease	Every donor animal
Cell identity verification	COI sequencing or species-specific PCR	Species identity confirmed	MCB establishment and WCB generation
Adventitious agent testing	Mycoplasma and viral screening	Negative test results	MCB, WCB, and periodic requalification
Genomic stability	Karyotyping or genomic analysis	No major chromosomal abnormalities	Every 20–30 passages
Tumorigenicity assessment	Soft agar assay and/or genomic evaluation	No evidence of uncontrolled transformation	MCB qualification and major process changes
Cell bank monitoring	Viability and contamination testing	Viability ≥70–80%; contamination negative	Every thaw cycle
Periodic requalification	Identity, stability, contamination review	All criteria maintained	Every 1–2 years

Note: The proposed acceptance criteria and monitoring frequencies represent expert-informed recommendations intended to support future standardization efforts and should not be interpreted as regulatory requirements.

The proposed framework emphasizes preventive control rather than relying solely on end-product testing. By implementing routine monitoring at critical stages of cell sourcing, banking, and expansion, potential hazards can be identified before they propagate throughout the manufacturing process. Such an approach aligns with established risk-management principles used in food safety systems while recognizing the unique biological characteristics of cultivated meat production.

Toward food-grade regulatory standards

While the proposed FSCLBF draws on established principles from the WHO Technical Report Series recommendations, ICH Q5D guidance, GMP systems, and regulatory expectations from agencies such as the FDA and EMA, the direct adoption of pharmaceutical standards may not be feasible for food-scale production. Cultivated meat products are ultimately intended to function as food commodities rather than therapeutic products, creating fundamentally different economic and operational requirements.

For example, extensive viral screening panels, routine whole-genome sequencing, and comprehensive characterization programs commonly used in pharmaceutical manufacturing may impose substantial costs when applied at food-production scales. Therefore, future regulatory systems should focus on developing risk-based, scalable, and economically feasible approaches that maintain high levels of safety while remaining compatible with commercial food production. This concept aligns with the emerging Good Food Manufacturing Practices (GFMP) framework, which adapts core GMP principles to the operational realities of large-scale food manufacturing (Okpala and Korzeniowska, 2023).

Potential examples of food-grade adaptations include rapid molecular identity assays, standardized microbial screening panels, targeted genomic stability assessments, automated cryostorage monitoring systems, and digital traceability platforms. Collectively, these approaches could provide a practical balance between scientific rigor, regulatory confidence, and economic sustainability. Ultimately, the establishment of internationally harmonized standards for cell line qualification and banking will be essential for ensuring regulatory consistency, facilitating international trade, improving consumer confidence, and supporting the responsible commercialization of cultivated meat products. The proposed FSCLBF provides a preliminary framework that can serve as a foundation for future regulatory development, scientific validation, and global standardization efforts.

Future perspectives

As cultivated meat transitions from pilot-scale demonstrations to commercial manufacturing, the development of robust, science-based systems for cell line qualification and banking will become increasingly important for ensuring food safety, consumer confidence, regulatory consistency, and long-term industry sustainability. Although recent regulatory approvals in Singapore, the United States, Israel, and Australia represent important milestones, significant challenges remain regarding standardization, transparency, traceability, and risk management. Addressing these challenges will require coordinated efforts among regulators, industry stakeholders, academic researchers, and international organizations.

Establishing global standards for cell line qualification

One of the highest priorities for the coming decade is the development of internationally harmonized standards for food-grade cell line qualification and banking. While the biopharmaceutical sector benefits from well-established guidance documents issued by organizations such as the WHO, ICH, FDA, and EMA, equivalent standards for cultivated meat production do not currently exist. Future regulatory efforts should focus on defining minimum requirements for cell identity verification, adventitious agent testing, genomic stability monitoring, tumorigenicity assessment, cell bank qualification, and periodic requalification procedures. Harmonized standards would facilitate regulatory consistency, reduce duplication of testing efforts, improve traceability, and support international commercialization of cultivated meat products.

Open-access cell banks and collaborative safety initiatives

Establishing shared biological resources could substantially accelerate innovation while improving biosafety assurance across the cultivated meat sector. Open-access repositories containing well-characterized food-grade cell lines from multiple species would reduce duplication of effort among companies and research institutions while improving transparency and reproducibility. Several initiatives have already begun moving in this direction. The Good Food Institute (GFI) has supported efforts to develop open-source cultivated meat cell lines and publicly accessible biological resources. Similarly, the Cultivated Meat Safety Initiative (CMSI), coordinated by New Harvest Foundation and Vireo Advisors, has sought to identify scientific knowledge gaps and facilitate evidence-based safety evaluation frameworks. Despite their importance, these initiatives currently remain largely advisory and research-oriented. Future progress will depend on translating these efforts into internationally recognized technical standards and validated reference materials that can support regulatory review and industry-wide adoption.

Development of good food manufacturing practices (GFMP)

An important future challenge involves adapting quality management systems originally developed for pharmaceuticals to the operational realities of food production. Although Good Manufacturing Practice (GMP) frameworks provide valuable guidance on contamination control, documentation, and biological material characterization, directly implementing pharmaceutical-grade requirements may not be economically feasible for cultivated meat manufacturing. This challenge has led to increasing interest in the concept of Good Food Manufacturing Practices (GFMP), which may be viewed as a food-specific adaptation of GMP principles. Under such an approach, safety-critical elements, including traceability, contamination control, cell authentication, and quality documentation, would be maintained. At the same time, testing strategies would be tailored to the scale, economics, and risk profile of food production. The development of GFMP guidance could provide a practical framework for balancing scientific rigor, regulatory confidence, and commercial feasibility.

Emerging technologies for affordable safety monitoring

Technological innovation will play a critical role in enabling safe and economically sustainable cultivated meat production. Current methods for genomic characterization, contamination detection, and cell bank monitoring are often derived from pharmaceutical manufacturing and may be difficult to implement routinely at food-production scales. Future advances in molecular diagnostics, biosensors, portable sequencing technologies, digital quality management systems, and automated cryostorage monitoring platforms could enable rapid, cost-effective surveillance of cell identity, viability, contamination status, and genomic stability. The development of validated, food-specific analytical tools would help reduce testing costs while maintaining high safety standards and regulatory confidence (Macedo et al., 2024). Similarly, spectroscopy-based analytical platforms coupled with machine learning have demonstrated strong potential for rapid, non-destructive classification and quality assessment of food products and may provide valuable tools for future cultivated meat monitoring systems (Sarker et al., 2024).

Post-market monitoring and adaptive risk management

As cultivated meat products enter commercial markets, regulatory oversight will likely need to extend beyond pre-market safety evaluation. Post-market monitoring systems could provide an additional layer of consumer protection by detecting unexpected changes in product composition, allergenicity, nutritional characteristics, or manufacturing performance (Zandonadi et al., 2025). In this context, concepts analogous to those used in the pharmaceutical industry's pharmacovigilance systems may provide a useful model. Although cultivated meat is fundamentally different from therapeutic products, the underlying principle of continuous safety evaluation remains highly relevant. Future post-market surveillance programs could integrate routine batch testing, microbial and genomic monitoring, digital traceability systems, consumer feedback mechanisms, and structured reporting of quality deviations. Such systems would support adaptive risk management and strengthen public confidence as production technologies continue to evolve.

Sustainability and long-term industry development

Beyond safety considerations, future regulatory and quality-control systems should also contribute to the broader sustainability objectives of cultivated meat production. Consistent with the FAO framework, sustainability should be considered across human health, environmental, social, and economic dimensions. Reliable cell line qualification systems, transparent safety assessment procedures, and internationally harmonized standards can contribute not only to food safety but also to resource efficiency, consumer acceptance, equitable market access, and long-term economic viability. In summary, the future of cultivated meat safety will depend on the successful integration of scientific innovation, regulatory harmonization, and international collaboration. The establishment of standardized cell line qualification criteria, implementation of food-grade quality management systems, development of shared biological resources, and adoption of adaptive post-market monitoring strategies will provide the foundation for a safe, transparent, and sustainable cultivated meat industry. By integrating expertise from cell biology, food science, biotechnology, and regulatory science, future frameworks can ensure that cultivated meat achieves its potential as a safe and trusted component of the global food system.

Conclusion

Cell lines and cell banks constitute the biological foundation of cultivated meat production and play a central role in determining product safety, quality, reproducibility, and regulatory acceptability. As the cultivated meat sector advances toward commercial-scale manufacturing, ensuring that production cell lines are authentic, genetically stable, traceable, and free of contamination will be essential to maintaining consumer confidence and protecting public health. Consequently, cell line qualification and cell banking should be regarded not merely as technical requirements but as critical components of food safety assurance. This review highlights that, despite rapid technological progress, substantial variability remains in current quality control practices across the cultivated meat industry. Comparative analysis of publicly available regulatory dossiers from GOOD Meat, UPSIDE Foods, and Vow Group revealed significant differences in donor animal qualification, cell sourcing documentation, adventitious agent testing, genomic stability assessment, tumorigenicity evaluation, and cell bank monitoring. These findings demonstrate that although companies share common safety objectives, there is currently no internationally harmonized approach to food-grade cell line qualification and banking. The review further identifies microbial contamination, adventitious agents, genomic instability, and tumorigenicity as the highest-priority hazards requiring systematic control throughout cell line development and maintenance. In response to these challenges, a risk-based Food-Safe Cell Line and Banking Framework (FSCLBF) was proposed to provide a structured approach for donor animal qualification, cell authentication, contamination control, genomic monitoring, tumorigenicity assessment, and periodic requalification of cell banks. Although the framework requires further validation and refinement, it offers a practical foundation for future standardization efforts and regulatory development. Looking forward, the successful commercialization of cultivated meat will depend on the establishment of internationally harmonized standards, the implementation of food-grade quality management systems, the development of shared biological resources, and the adoption of scalable, economically feasible safety monitoring technologies. Achieving these goals will require sustained collaboration among regulators, industry stakeholders, academic researchers, and international organizations. Ultimately, the development of globally accepted standards for food-safe cell lines and cell banking will support not only regulatory consistency and consumer trust but also the broader sustainability objectives of cultivated meat production. By integrating principles from cell biology, food safety, biotechnology, and regulatory science, the cultivated meat sector can advance toward a transparent, resilient, and scientifically robust food production system that contributes to future global protein security.

Funding sources

This present work did not receive any specific grant from funding agencies.

Declaration of AI and AI-assisted Technologies in the Writing Process

The authors affirm that AI tools were not used in the drafting of the manuscript, the production of images or graphical elements, or in the collection and analysis of data.

CRediT authorship contribution statement

Nayeem Mia: Writing – review & editing, Writing – original draft, Visualization, Validation, Software, Resources, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization. Md. Abul Hashem: Writing – review & editing. Md. Mukhlesur Rahman: Writing – review & editing. Zubayed Ahamed: Writing – review & editing.

Disclosures

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.