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

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

Milestones of Biotechnology

Development Year
Pasteur proposes that microbes that cause fermentation 1857
Discovery of the genetic basis of heredity by Gregor Mendel 1860
Microbes are used to treat sewage for the first time in Manchester, England. 1914
DNA is proven to carry genetic information 1944
Elucidation of the double-helical structure of DNA by Francis Crick and James Walson 1953
Discovery of restriction enzymes 1971
Preparation of monoclonal antibodies by Cesar Milstein and George Kohler 1975
Sequencing of DNA by Sanger and Coulson 1975
Discovery of PCR 1985
Development of human genome project 1990
Maintenance of human stem cells in culture 1998
The human genome, the first mammalian genome sequenced 2001

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