Methods
to Manage and Assess Safety
There
is a critical need to fulfill the dietary protein demands of the projected
population of almost 10 billion in a sustainable and healthy manner by 2050, as
demand and supply continuously widen the gap. Thus, Industry 4.0 and the Internet
of Things (IoT), which includes the digitalization and automation of industrial
manufacturing technologies that can foster the development of novel dietary
proteins in order to address the food sustainability and security issues of the
expanding population. The potential for the success of cultured meat is directly
based on scientific advances from both industry and academia, where reduction
in both upstream and downstream production costs by the creation of robust and
flexible bioprocesses are essential for growth. Nonetheless, bioreactors are
containers that ensure optimal conditions for the growth of CM cell lines in
either continuous or batch-wise operation, whereas perfusion bioreactors ensure
the continuous culturing of cells and are most commonly employed in the cell
culture industry today. The growing meat tissues are placed on a
growth-supporting biomaterial (scaffold) in these bioreactors within the flow of
the media and nutrients that offers high-quality end products. Hence, designing
large-scale bioreactors with media recycling technology to ensure minimal
inputs and wastage and real-time quality control systems for balancing pH,
osmotic homeostasis, temperature, and pressure is an immediate need for commercial
production.
Safety
of Manufacturing Process
The cultured meat safety basically depends on the manufacturing process, which is employed has to be designed with the product safety in mind that has to be verified with a safety assessment of the final product. Thus, as part of creating safe, consistent, high-quality products for the commercial market, most of the current practices and protocols are directly translated from related fields to the cell-cultured meat manufacturing context. However, it is not enough to safeguard the consumer, where all the basic food safety applications such as GMP, ISO/FSSC 22000, SQF, or BRCS concepts need to be kept in mind while developing these new processes.
Good
Manufacturing Practices
Good
Manufacturing Practice (GMP) relates to the overall good housekeeping ethics
intended to prevent any hazard from occurring and is a set of widely applied
food production practices that describe appropriate design and construction of
facilities, sanitary operations, and maintenance, and production and process
controls that ensure reliable results and safe production of food. GMPs and
standard operating procedures from the food, feed, meat and seafood, and
pharmaceutical and medical fields are prospected to be applied in the cultured
meat manufacturing process to ensure consistent quality and safety of the
product. In addition, Good Hygiene Practices (GHPs) are key essential factors in
the food supply chain and can be audited alongside GMP compliance. GHPs extend
beyond industrial food manufacturing into the service industry, such as
catering, hotels, and restaurants.
Good
Cell Culture Practices
Good Cell Culture Practices (GCCP) concepts are also applicable to cell-cultured meats. Hence, GCCP principles are typically applied for in-vitro systems used in basic research, medicines, and pharmacology to maximize the reliability of cell and tissue products, while some aspects are applied for the handling and management of cultured meat. GCCP sets minimum standards and provides recommendations for in-vitro work to prevent contamination while ensuring the quality of the final product. GCCP suggests the application of aseptic techniques while avoiding antibiotic use, developing standard operating procedures, and controlling the quality of media supplements and other inputs. Documentation is an important part of maintaining a detailed record of all procedures that can provide information on what potential contaminants or hazardous inputs may be present in the final product, which can support targeted screening for potentially harmful impurities and contaminants. On the other hand, the standards set by GCCP are usually prohibitive for the food industry, but the modification of existing practices and technologies can advance the development of food-grade GCCP guidelines based on existing principles.
Code
of Hygienic Practices
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Until
the relationships between source animal health and final food product are
understood for cultured meat products, guidance regarding the health of food
animals or recommendations related to the use of animal-derived materials for
medical procedures may be useful. The existing code of hygienic practices for
animal food production has already been used in medical organ farming (i.e.
pigs for the heart) that includes procedures for herd management to maintain
animal health and the prevention of animal disease. Furthermore, animals used
as source animals for xenotransplantation (i.e., use of live cells, tissues, or
organs from an animal source in a human recipient) are recommended to be
healthy and reside in specific pathogen-free closed herds with health screening
programs are the practical applications industry embracing today. These
programs can track and monitor infectious diseases and document animal health
history. Such a proactive approach is especially useful rather than trying to
build validated screening tests to detect endogenous pathogens. Hence, active
herd/flock management and documentation, along with monitoring and screening of
source animals for potential infectious disease, will lower the risk of
culturing affected cells, or else isolation of animal-derived components of
cell media (e.g., BSA, trypsin, collagen, etc.) from low-risk animals reduces
the chance of contamination.
Hazard
Analysis and Risk Management
Management systems can help prevent or minimize hazards and manage specific risks within a process, where implementation of systems to manage food safety risks such as Hazard Analysis and Critical Control Point (HACCP), Hazard Analysis and Risk-Based Preventative Controls (HARPC), Food Safety Plan development, and other risk-based preventative control programs may be applied to cell-cultured meat/seafood manufacturing processes. In each approach, a systematic gap analysis has to be performed for each step of the manufacturing process to identify every possible hazard or source of contamination. An SOP or control procedure has to be introduced to prevent, eliminate, or minimize each hazard based on its risk, where a risk prevention system is a regulatory standard or law and is often considered essential to achieving greater market access in many countries. Detailed documentation of each process step and identification of potential hazards can help identify the impurities and contaminants that warrant examination in the final product.
Input
Materials and Equipment Selection
Input material selection and control provide a great option to prevent contamination risks, where more general frameworks can be supplemented or integrated with practices from specific fields. Cell culture materials can be selected to comply with current GMP and food-grade specifications. The selection and management of equipment, disposables, and cleaning agents made of food-safe materials will minimize the amount of extractable and leachable toxic compounds migrating into the product. Standardized tests for such contaminants to ensure quality and safety are already drawn from the biopharmaceutical, medical device, and cosmetics industries, where much has already been established related to testing regimes for process-related contaminants and residue measurement.
Contaminant
Control
Once the
initial cell lines are developed, tested, and verified, every new cell line can
be cultivated in a quarantine incubator and verified that they are pathogen
free. Microbiological controls and testing derived from practices involving
stem cells or in vitro practices are already applied throughout the
manufacturing process. Nonetheless, there are many methods exist to evaluate
and reduce contamination from infectious agents that can be introduced via
equipment, handling, material inputs, or processes, where cultures are exposed
to the air. A system of daily observation and regular screening of cultures,
media, and equipment using standard protocols should be adapted from those
provided in regulatory guidance or pharmacopeial standards. A process of rapid
microbiological testing and implementation of effective controls and procedures
to limit contamination is essential, where viruses and other undesirable agents
can be reduced or removed from serum and final products through heat
inactivation, irradiation, or filtration. Further, the cells intended for
banking or preservation may be screened for bacteria, yeast, fungi, prions, and
viruses to prevent unintentional propagation in future batches.
References:
https://ift.onlinelibrary.wiley.com/doi/full/10.1111/1541-4337.12853
https://www.foodincanada.com/features/the-food-safety-advantages-of-lab-grown-meat/
https://www.frontiersin.org/articles/10.3389/fnut.2020.00007/full
https://www.centerforfoodsafety.org/blog/6458/is-lab-grown-meat-healthy-and-safe-to-consume
https://www.mdpi.com/2304-8158/10/12/2922
The cultured meat safety basically depends on the manufacturing process, which is employed has to be designed with the product safety in mind that has to be verified with a safety assessment of the final product. Thus, as part of creating safe, consistent, high-quality products for the commercial market, most of the current practices and protocols are directly translated from related fields to the cell-cultured meat manufacturing context. However, it is not enough to safeguard the consumer, where all the basic food safety applications such as GMP, ISO/FSSC 22000, SQF, or BRCS concepts need to be kept in mind while developing these new processes.
Good Cell Culture Practices (GCCP) concepts are also applicable to cell-cultured meats. Hence, GCCP principles are typically applied for in-vitro systems used in basic research, medicines, and pharmacology to maximize the reliability of cell and tissue products, while some aspects are applied for the handling and management of cultured meat. GCCP sets minimum standards and provides recommendations for in-vitro work to prevent contamination while ensuring the quality of the final product. GCCP suggests the application of aseptic techniques while avoiding antibiotic use, developing standard operating procedures, and controlling the quality of media supplements and other inputs. Documentation is an important part of maintaining a detailed record of all procedures that can provide information on what potential contaminants or hazardous inputs may be present in the final product, which can support targeted screening for potentially harmful impurities and contaminants. On the other hand, the standards set by GCCP are usually prohibitive for the food industry, but the modification of existing practices and technologies can advance the development of food-grade GCCP guidelines based on existing principles.
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Management systems can help prevent or minimize hazards and manage specific risks within a process, where implementation of systems to manage food safety risks such as Hazard Analysis and Critical Control Point (HACCP), Hazard Analysis and Risk-Based Preventative Controls (HARPC), Food Safety Plan development, and other risk-based preventative control programs may be applied to cell-cultured meat/seafood manufacturing processes. In each approach, a systematic gap analysis has to be performed for each step of the manufacturing process to identify every possible hazard or source of contamination. An SOP or control procedure has to be introduced to prevent, eliminate, or minimize each hazard based on its risk, where a risk prevention system is a regulatory standard or law and is often considered essential to achieving greater market access in many countries. Detailed documentation of each process step and identification of potential hazards can help identify the impurities and contaminants that warrant examination in the final product.
Input material selection and control provide a great option to prevent contamination risks, where more general frameworks can be supplemented or integrated with practices from specific fields. Cell culture materials can be selected to comply with current GMP and food-grade specifications. The selection and management of equipment, disposables, and cleaning agents made of food-safe materials will minimize the amount of extractable and leachable toxic compounds migrating into the product. Standardized tests for such contaminants to ensure quality and safety are already drawn from the biopharmaceutical, medical device, and cosmetics industries, where much has already been established related to testing regimes for process-related contaminants and residue measurement.
https://ift.onlinelibrary.wiley.com/doi/full/10.1111/1541-4337.12853
https://www.foodincanada.com/features/the-food-safety-advantages-of-lab-grown-meat/
https://www.frontiersin.org/articles/10.3389/fnut.2020.00007/full
https://www.centerforfoodsafety.org/blog/6458/is-lab-grown-meat-healthy-and-safe-to-consume
https://www.mdpi.com/2304-8158/10/12/2922
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