Recombinant protein reigns genetic engineering sector as research and development segment. Recombinant protein therapeutics have always attracted medical specialists and researchers to dive deep to gain knowledge about bio-molecular roots of human diseases. It is known as the core of human medical biotechnology sector. This significance is gained after decades of technological advancements and global expansions in this field. Hundreds of companies are indulged in development of these therapeutics and many more are developing their portfolio in this direction.
Recombinant strategies are developed for prevention therapies
Animal reproduction is another major area that is facilitated by recombinant protein production. Mammalian cells and fungi involve recombinant production of hormones for reproduction and fibrolytic enzymes to enhance performance in animals which gives rise to low-cost products development in livestock. New recombinant strategies have been developed for prevention and therapies like passive immunization, for the immune system. Theses therapies control psychological process to reduce intake of antibodies.
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Further growth in the recombinant protein segment is expected as many different products are in line to be launched. These products can be antibodies, vaccines, small molecules, cell therapies, DNA-RNA synthetics and genes. Four Amgen products namely drug etanercept, pegfilgrastim, darbepoetin alfa and Epogen are emerging as leaders in this segment. Hematology and Oncology are surfacing as top revenue generators.
High production cost is major challenge
Therapeutic recombinant proteins are segregated into various molecular types that are antibody-based drugs, blood factors, engineered protein scaffolds, Fc fusion proteins, hormones, interleukins, bone morphogenetic proteins, interferons and thrombolytic where Antibody-based drugs are gaining popularity very rapidly. Researches and clinical developments are being dedicated towards creating second generation protein products. Many strategies like reformulation and pegylation are adopted in this regard. The main aim of these protein products is to last longer in body and have improved pharmacokinetics. These properties are anticipated to lower administration frequency and improve patient compliance. Although the future of protein development is bright, many challenges are yet to be addressed. High production cost is a major challenge followed by improved productivity and quality maintenance.
Scientists have mapped proteins in human body organs creating a larger platform to understand genetics behind human diseases. The future has protein therapies for novel diseases in store that will be achieved by combining MAbs and genes. Overall production of recombinant proteins in E-coli is now enhanced with a bio-process engineering called high cell density fermentation. Aerobic cell condition during cell growth is maintained by using various methods like increasing aeration rate, decreasing temperature, increasing potential pressure and feeding O₂-rich air. Tender coconut water is used as growth media for microbes and for expression of recombinant proteins.
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Biotech industries like Biocon have realized the potential in recombinant protein and are signing agreements with universities to setup industrial courses for interested students. Association of Biotechnology Led Enterprises encourage industry cum academic interactions that generates opportunities for collaborative research, technology transfer and human resource development. Biotechnology industry Research Assistance Council has been set up in India as interface for department of Biotechnology for biotech companies.