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Review
. 2025 May 27;15(11):1570.
doi: 10.3390/ani15111570.

Genetically Modified Animal-Derived Products: From Regulations to Applications

Carlos Fajardo  1   2 , Marta Macedo  2   3 , Tonka Buha  2   3   4 , Marcos De Donato  5   6 , Benjamin Costas  2   3 , Juan Miguel Mancera  1
Affiliations
Review

Genetically Modified Animal-Derived Products: From Regulations to Applications

Carlos Fajardo et al. Animals (Basel). .

Abstract

Biotechnological advances applied to the generation of genetically modified (GM) animals have shown the potential to develop innovative solutions for different challenges in key areas such as agriculture and human medicine. Despite its enormous potential, the deployment of genetic modification in animals, and its subsequent commercialization, does not meet the same public acceptance as GM plant-derived products, which are currently widely adopted around the world. In this review, we highlight the main examples of GM and gene-edited animal-derived products already approved by the FDA and discuss the regulatory context inherent to such processes, including the risk-based assessment analysis based on a case-by-case evaluation. Moreover, cases of GM animals already approved by other jurisdictions around the world are also discussed.

Keywords: CRISPR; FDA; GMO; gene-editing; genetic engineering; intentional genomic alterations.

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Conflict of interest statement

Tonka Buha was employed by the company SPAROS Lda. The remaining authors declare no conflicts of interest.

Figures

Figure 5
Figure 5
Generation process of GSPs. These animals are created by micro-injecting rDNA construct into fertilized eggs (pronuclei). The genome integration and disruption of GGTA1 gene is mediated by homologous recombination. Gestation is achieved by transferring the embryos to the oviduct of surrogate mothers. Around 10% of the live births produce transgenic animals. Inactivation of GGTA1 gene, responsible for producing alpha-gal sugar (antigen), allows the generation of food that can be consumed by people who suffer from alpha-gal syndrome (AGS). Moreover, GSP-derived organs (e.g., heart, kidney) could be used for xenotransplantation. Image modified from Peterson et al. [126].
Figure 1
Figure 1
Main examples of currently FDA-listed GM animals and their applications.
Figure 2
Figure 2
Comparative growth rate between AAS and wild type S. salar. As a result of the genetic modification, AAS can reach the market size in nearly half time in comparison to its wild counterparts.
Figure 3
Figure 3
Generation process of AAS. The rDNA construct (opAFP-GHc2) is microinjected into fertilized eggs to obtain the transgenic founders. Image modified from Walton et al. [72].
Figure 4
Figure 4
Design process of AAS. GH gene from Chinook salmon (a) is ligated to a promoter derived from the ocean pout (b). Integrated into Atlantic salmon DNA (c), recombinant GH gene construct controls the expression of GH during all year instead of only in summer. As a result, AAS can reach the market size (4–5 kg) in nearly half of the time (16–20 months) in comparison to their non-GM counterparts (28–32 months).
See this image and copyright information in PMC

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