PLANT - MADE  PHARMACEUTICALS

-By Swadha Shree

-Batch(2k20), Deptt. of

Chemical Engg.

-BIT Sindri, Dhanbad

INTRODUCTION:

Biotechnology has immense potential from care to health-based products, food, pharma, etc., for the benefit of mankind. Plant-based solutions are a substantive subset to this, which is also critical in finding a nature-based solution in human care. Vast treasures of biodiversity locked up in the genus of flora ought to be researched to diversify possible remedies alongside scoping the best possible role of symbiotic eco-anthro relationship.

With the sudden peak in demand for medicine/pharmaceuticals, the lengthy discussion for various sources of these products to meet the urgent need of Populus is in rage. Among many such sources of drugs lies Plant-made Pharmaceuticals, also widely referred to as PMPs in the professional field.

The help of Flora and Fauna has always been mentioned in old scriptures and epics, often emphasized too. But due to successive claims of relative less-impact and not much detailed preparations skill and interest shown, these sources have laid dormant/less-encouraged till the 2010s.

The latest studies shed light on the bright and hopeful future of molecular farming, the production of Plant-made Pharmaceuticals, as a progressive way of making a vast spectrum of proteins used in research, diagnostics, and medical sciences.

HISTORY 

To provide some deep insight and background to the modern-day PMP's, its emergence should be mentioned accordingly;

         

Primordial works on PMP's were primarily targeted towards the smooth and efficient ways to produce vaccines and medicinal essentials, often through the usage of largely-product suitable crops such as rice and corn. However, many obstacles were faced in this field, which also led to some progressive deviation in the future. One such example to present would be a time around 2002 when the progress in this field came to a standstill because of the issues concerning cross-contamination of such field crops, hence, leading the lens of research from 'absolute focus on crops' to 'tobacco and other limitedly-produced crops'.

         

Dr. J Christopher Hall, a Canadian Plant-scientist, was a hugely influential figure in this field. His work from the beginning of the 1990s laid the foundation and emphasis on how the usage of transgenic tobacco is very advantageous in producing antibody drugs.

ADVANTAGES & DISADVANTAGES

As the discussion is put forth, the pros & cons are were weighed accordingly, henceforth, to mention some of those advantages will be:

 •The expandable, extensible, and expansible nature of this comparatively less-explored field opens the door to many unconventional and out-of-the-box research.

 •The fast scalability and the low-budget production of PMPs might as well be one of the significant reasons for scientists' and industry's excitement towards the future of Biopharming.

           

These genetically modified plants manufacture pharmaceutical compounds (protein-based), exempli gratia, immunogenic proteins, and antibodies. The pillar of PMP's craze in the medical market can be tracked because compared to microbial systems much more vast spectrum of valuable compounds can be extracted from plants. The estimated reason can be the similarities between the metabolic pathways used by both the plants and mammalian cells. However, to add, the risks of pathogenic infection as it is observed in animal culture are not that prevalent among the plants, leading to an advantage that the production of biopharmaceuticals in plants could very much help get the better of current shortage in production capacity.

           

All this leads the path to one direction, i.e., superb market opportunities, and can be considered a good situation. In addition to what has been said, this enthusiasm is also shared by the business analysts of this field. According to their views and calls, this can be the "Emergence of a genuine competitive force in the large-scale production of recombinant Proteins."

          

Be that as it may, no endeavour comes with a clean slate and success guarantee, the same way, PMP's also pose a fair share of risks to their investors and consumers.

          

A significant issue with the usage of plants is that their expansion can lead to the possible threat of contamination of the wider environment. Addressing this issue, Simon Barber of EuropaBio, the European bioindustry association, says, "Plants are a wonderful vehicle for high-quality, consistent production, the question is where do you grow them."

            

The issue was first highlighted in 2003. This incident left a bad taste behind and had a catastrophic effect on the whole PMP sector in States. It fends off and unimpressed the pharmaceutical giants that were the most prominent patron of this novel production. The incident was actually a discovery that PMP prodigy of the United States, ProdiGene reported, the contamination of Soybeans(test crops) in two of its fields, namely each in Nebraska and Lowa. This led to the company's untimely downfall, further acquisition, and sincere unrest in potential investors. 

BIOPHARMING

With an open discussion for upcoming topics, some terms shall be predefined to the main context, such as Biopharming.

          

'Biopharming' entails the usage of genetically modified plants to produce a vast spectrum of pharmaceuticals and industrial products. Additionally, the pharmaceutical products obtained from these procedures are called 'Plant-made Pharmaceuticals'.

UNDERSTANDING PMP INDUSTRY AND PRODUCTION

           

Plant-based-Pharma, like other human care products, is placed under stringent regulations. In India, Genetic Engineering Appraisal Committee evaluates the outcome from a genetic perspective. Accordingly, drugs under the Drugs and Cosmetics act 1945 are regulated by CDSCO. Individual countries grant accreditation according to their own norms and standards, as seen in the US Department of Agriculture (USDA) and Food and Drug Administration, which plays the regulatory role of Plant-based Pharmaceuticals. While USDA is concerned with R&D production, field trials, production, and logistical amenities and planned and phased the seed introduction into cultivation. FDA is more concerned with distributive, evaluative production-related approvals. FDA regulates PMP as to be used as human medicine.

           

 Biotechnology is a sector of responsibility, requiring utmost care, having a direct impact on human well-being. It cannot afford to be complacent; manufacturers/producers have an immediate obligation to the efficiency and impact of their product, plus they must ensure that laboratory conditions and production process follow safety guidelines. 

             

They are also required to support regulatory authorities in quest of approval for their products. They should provide the necessary data, be compliant with the field trial norms, share needed information and challenges or cautions indulged. In addition to that, the Biotech industry also requires an ethical code of conduct, and producers must adhere to best standards and practices as upheld by industry ethics; it helps build industrial mutual trust. 

PRODUCT MILESTONE

As per the IMS Institute for Healthcare informatics, 2016----- Bio-products will dominate Global Pharma Market anticipated to reach USD 390 Billion by 2020. 6 out of 10 global drug products in 2015 biologics.

       

 •We had come a long way, from 1982, when Insulin became the first recombinant protein produced by E-coli bacteria.

              

•First plant-based pharma protein was albumin produced utilizing transgenic tobacco and potato.

              

•In 2006, a plant-made vaccine was made for the first time for new castle disease poultry by using tobacco plants.

              

•Further, in 2008, PlantForm Corporation established a manufacturing platform to make therapeutic bio-products and other bio-similars of antibody drugs.

              

•Infact, cell-based enzyme replacement therapy has also been developing.

              

•A significant breakthrough is ZMapp, an experimental drug used for treating Ebola virus patients.

CONCLUSION

This might've covered the broad and shallow overview of PMP's, but the enormous prospects of this field still remain under-researched, under-scoped, myopic. As we speak, the recent endeavours of PMP's are three broad classes of drugs from this community.

                

The first group is therapeutic antibodies and anti-body-derived proteins. The second group is sub-unit vaccine antigens, while the third class present of PMPs is therapeutic enzymes. 

                

However, many of the sub-classes of these groups are still under clinical trials and face an uncertain future as the research progresses. Furthermore, looking at the generics sector's impressive manufacturing capacity previously established, PMPs shall look forward to a competitive lot and take essential supports from plant production platforms to advance effectively. 

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