- Cell line development
Developing cultivated meat products will require alignment on a set of criteria and methodologies to demonstrate that the product sufficiently recapitulates the structure and biology of muscle tissue. While existing assays can be adapted from both meat science and muscle tissue engineering, there is currently no streamlined, consistent set of analytical tools to characterize this new type of food product. Research to align on the appropriate assays—followed by commercialization of kits or services to conduct them—would introduce standardization that can accelerate R&D efforts.
The companies that are developing cultivated meat (CM) will need to conduct both quantitative and qualitative analyses to assess the quality of their cell-based meat products. While the specific criteria and regulatory guidelines are not yet fully defined, we can anticipate that methodologies will be adapted from the food industry and tissue engineering research. However, the existing analytical techniques do not translate in a straightforward way to the needs of CM. Meat analysis for the food industry primarily assesses nutrition and safety, with little to no information about cell types and tissue structure. Metrics for assessing quality are often crude, qualitative visual measures. Conversely, characterizing engineered tissues grown in scientific laboratories provides information on cells and tissue, but the techniques rely on expensive reagents and equipment, and are often labor-intensive.
There is an opportunity for an analytical reagents company or contract research organization to enter this space, either to directly conduct the required analyses or to manufacture laboratory equipment and assay kits to sell to CM companies for in-house testing. We anticipate that the types of assessments may include: nutritional content, safety (for example, testing for presence of toxins and dangerous microbes), mechanical properties, types of cells present, cell density and viability, cell and tissue structure (such as length and alignment of myofibers), and amount and structure of muscle-specific proteins.
To conduct these analyses, it would be beneficial to scale-down the required sample sizes for standard meat analysis testing, and to streamline or bundle laboratory-based assays like Western blots, qPCR, and immunohistochemical staining and microscopy to provide holistic characterization inexpensively and with minimal handling. Some high-throughput microscopy platforms already exist, but these are expensive and could potentially be adapted to the needs of CM producers. This could be accomplished by performing the analysis of all relevant markers within one culture plate or kit, automating image analysis of myotubes and cell coverage, and adapting these analyses for different types of 3D culture systems.
Enabling cultivated meat companies to characterize and assess the quality of their products in a cost-effective, standardized way will be hugely impactful for both companies and regulators. The use of thorough and consistent analytical tools, if adopted by all or most CM companies, could facilitate the pathway to regulatory approval. If no entity decides to enter this opportunity space to streamline analysis efforts, the existing CM companies will still conduct a variety of analyses, but they will be more expensive and variable than they might be otherwise and they will require expending significant in-house resources in a duplicative manner. Addressing this need in a cost-effective way could prove both profitable and beneficial to the industry’s path toward market adoption. For the company that addresses this opportunity, there is also the potential to reach a broader variety of customers within the biotechnology industry and academic research institutions.
- Ben-Arye and Levenberg 2019: Discusses meat analysis considerations.
- Ben-Arye et al. 2020 used various methods to assess muscle tissue formation by cells on a soy protein scaffold.
- Example of a contractor that conducts a variety of meat analysis assays to comply with USDA regulations: Certified Laboratories
- High Content Screening Platforms (high throughput microscopy): [Thermo Fisher Cell InSight Systems]
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