Recombinant technology is the manipulation of the host genome by adding a foreign altered gene vector to produce new genetic combinations that are of value to science, health, and industry. Here, the introduced gene vector is the recombinant gene, usually added to change the phenotype of an organism. To achieve genetically modified organisms (GMOs), isolation of pure DNA, cutting at recognised locations of DNA to get the desired gene, amplification of the desired gene using polymerase chain reaction, ligation of the cut fragment of DNA and vector, followed by integration of recombinant DNA into the host using either microinjection or a gene gun is very crucial. Once the recombinant DNA is inserted into the host cell, it multiplies and is expressed.
According to the US Department of Agriculture (USDA), GMO seeds are used to plant over 90 per cent of all maize (corn), cotton, and soy grown in the United States, which means that many of the foods you eat likely contain GMOs. With its wide range of applications, recombinant technology plays a particularly significant and revolutionary role in the nutraceutical industry. Recombinant DNA technology provides the control and precision needed to improve nutritional content and modify biosynthetic pathways.
Challenges and ethical considerations
The ecological effects of releasing genetically modified organisms into the ecosystem are unpredictable. Imagine a puzzle with all the pieces coming together forming a bigger picture. Now, changing the colour or shape of one puzzle piece will disrupt the bigger picture. Similarly, the introduction of organisms with altered genes has the potential to disrupt the delicate equilibrium present in any given habitat. Once an organism is released into the environment, it is usually impossible to reverse; nevertheless, it is possible to introduce “suicide genes” or modify the organism such that it can only live in the presence of supplements.
The metabolic pathways within a cell could be affected by DNA manipulation; could these repercussions result in cancer, metabolic disorders, or the emergence of a new disease? What effects might a mutated designed gene have? Could it transform a creature into an uncontrollable pathogen? What effects will novel gene combinations have in the long run? Is genetic modification morally wrong? Do we allow nature to run its course when it’s ready? Is it appropriate for a person or business to be able to patent a gene and thus practically possess it? Answering these questions with 100% assurance is a challenge unsolved to this day.
Regulatory
The fact that plant biotechnology is still in its early stages, recombinant nutraceutical manufacturing is complicated. The regulatory framework was slow to become established and hadn’t been tested to the full extent globally yet. It was not until 2009 that the European Medicines Agency (EMA) published a ‘Guideline on the quality of biological active substances produced by stable transgene expression in higher plants.’ This guideline’s main goal is to modify certain parts of the quality guidelines that are currently in place for other production systems to account for the unique circumstances of transgenic higher plant-based systems. Before that, the agency’s Biologics Working Party had produced a document titled “Points to Consider” that was made accessible in 2002. The Pharma-Planta project, funded by public research money in the European Union Framework 6 program, helped with the maturation of the ‘Points to Consider’ document into a ‘Guideline’.
Successful products
Several recombinant DNA technology products have been established in the market, for example, ELELYSO. A deficit in the enzyme human glucocerebrosidase, which is involved in the metabolism of glycolipids, results in Gaucher’s disease. Protalix, a 1993-founded Israeli company, produced glucocerebrosidase in a carrot cell fermentation system with great success. Another innovation is the perfect day whey protein isolate. They use precision fermentation technology using multicellular filamentous fungi to produce dairy proteins without the involvement of any cow. The fungi’s DNA is altered to know how to produce beta-lactoglobulin. The DNA structure was obtained from UniProt.
Conclusion
Molecular pharming and GMO nutraceutical products are relatively new in the market with immense potential to enhance properties, make production cheaper, or eliminate toxic characteristics. It is possible to produce nutraceuticals with specialised qualities that can address health issues, thanks to precise genetic manipulation. Recombinant technology has the power to transform the nutraceutical market through controlled cultivation of genetically modified plants or microorganisms; its efficiency could translate into more affordable and accessible nutraceutical products for consumers. As ideal as it may sound, it requires further research and regulatory considerations to ensure the safety and ethical use of recombinant technology in the production of nutraceuticals.