Milestones in Biotechnology

An Overview of Biotechnology

The term biotechnology refers to the use of living systems or molecular engineering to create and manufacture biologic therapies and products for patient care. Major product categories include large-molecule proteins, peptides, monoclonal antibodies, cell, tissue, and genetic therapies, liposomes, polymers, and molecularly engineered vaccines.

Traditionally, most medicines for human diseases were small-molecule (chemical) drugs manufactured by well-established pharmaceutical companies. Beginning in the 1980s, small start-up biotechnology companies began conducting research on large-molecule (biologic) drugs based on or engineered from biological tissue. Biologics are now a major focus of both pharmaceutical and biotech companies in terms of research and development (R&D) and product sales. We refer to this sector as biopharma. In addition, the evolution of biotechnology has seen the conversion of some well-established pharmaceutical companies into businesses whose predominant focus is biotech.

History of Biotechnology

• The term biotechnology was described in a bulletin of the Bureau of Biotechnology published in 1920.
• The concept of molecular biology, microbiology, and biotechnology has changed the scenario of pharmaceutical developments.
• The advancements in recombinant rDNA and monoclonal antibody technology have led to the development of new drug molecules.
• The most developing field in pharmaceutical biotechnology is the production of therapeutically active proteins and peptides.
• Many drugs and vaccines are developed by using basic concepts of biotechnology. Genomics, pharmacogenomics, proteomics, gene therapy, gene cloning, and tissue engineering are the present focus of biotechnology.

Fig.1 Timeline highlighting some important milestones of gene therapy. (Wirth, 2013)

Milestones of Biotechnology

Establishment of The Science and Business of Biotechnology

The 1990s saw an explosion in understanding the pathophysiology of human diseases, which led to the development of many innovative new medicines. Molecular engineering came to the fore, and the full potential of monoclonal antibodies was finally realized. Molecular engineering of protein molecules to create modified or new proteins with improved properties was another new technological advance in the 1990s. There was a 25-32 percent success rate for molecules entering clinical testing to an approved marketed product in biotechnology in the 1990s and 2000s.

The Future of Biotechnology

In the future, a key initiative will be the continued development of “personalized medicine”, or pharmacogenomics. This will allow prescribers to tailor individual treatment regimens to include medicines that have a high likelihood of offering a positive therapeutic outcome while avoiding those treatments that might result in serious adverse events. In all, more than 900 biotech-related molecules are in clinical trials around the world, monoclonal antibodies and vaccines were the two largest product areas. Business practices will continue to improve the efficiency of the development process. Consolidation among biotechnology companies will continue to occur, as well biotech-pharma mergers and acquisitions.

Biotechnology has had an extraordinary impact on health care during the past years. This will continue into the foreseeable future, as an understanding of the pathophysiology of many currently untreatable diseases grows, governments around the world continue to advance initiatives that support biotech innovation. The result will be a continuing stream of novel medicines, leading to breakthroughs in patient care.

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Reference

1. Wirth, T.; et al. History of gene therapy. Gene. 2013 Aug 10;525(2):162-9.