Biopharmaceuticals‘ or Biologics‘ as they are also known are medicines derived from biological sources as suggested by their ‘bio-‘ prefix. Technically this would include, medicines derived by extraction of natural products from plants, animals or even fungi. Penicillins would be one such noted example. Based on this broad definition, vaccines and blood products among others would also be considered biopharmaceuticals. In current usage however, the terms are associated almost exclusively with products derived from methods of ‘new biotechnology‘ such as recombinant techniques, as opposed to the wider definition encompassing mere natural-products extraction.
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Recombinant techniques, refer to gene manipulation methods which result in ‘new combinations of genes’, not previously seen in nature.
The term ‘Recombinant techniques’ refers to gene manipulation methods which result in ‘new combinations of genes‘ not previously seen in nature. The current usage of biopharmaceutical therefore encompasses, various recombinant therapeutic proteins such as colony stimulating factors e.g. G-CSF, protein hormones e.g. insulin, monoclonal antibodies e.g. trastuzumab and even more recently, products based upon nucleic acids (DNA and RNA) such as ‘anti-sense’ drugs. Underpinning this still novel and rapidly evolving sector is the applied science of biotechnology of which recombinant techniques are a part. Putting things into context, the Organisation for Economic Co-operation and Development (OECD) in a 1999 paper posited that biotechnology is “…the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services.” (OECD, 1999 cited in Paul and Lova, 2005:316) Such statements hold particular relevance given that biopharmaceuticals have become quite prevalent in today’s healthcare environment.
biotechnology is “the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services.“OECD 1999
As relates to biopharmaceuticals, the use of recombinant techniques means that living cells are ‘genetically-altered‘ resulting in their ability to produce substances used by man to treat diseases. At some point in the process, in vitro techniques are employed to bring about the necessary genetic modification. These genetic modification techniques are collectively referred to as ‘Genetic Engineering’. These novel gene combinations resulting from the application of recombinant techniques provide cellular blueprints for the production of new proteins which in turn are generally ‘not found’ in nature.
Typically, genetic engineering (for pharmaceutical purposes) sees the introduction of human genes into cells of other species. These cells are then placed into industrial-scale vats of growth media (liquid solutions of key nutrients and minerals, tailored to the growth needs of the specific cell-type) where they replicate. Once in the growth medium, the cells use the nutrients and other essential building blocks therein, to produce and secrete large quantities of the desired protein. One such cell type which is commonly used to host recombinant human (rh) genes for this purpose, is Chinese Hamster Ovary (CHO) cells. Another well known cell type is the bacteria Escherichia coli (E. Coli). The ‘rh’ designation is often attached as a prefix to the name of these new proteins indicating that the human gene was recombined with genetic material of another species.
Most of the proteins produced as a result of the new gene combinations mentioned above, will be structurally distinct from naturally occurring forms. Nonetheless, the aim is often to produce protein variants called Isoforms that are functionally equivalent to naturally occurring forms despite being structurally different. The goal in such cases such is substitution of the natural protein or supplementation where applicable. This can become necessary where the naturally occurring protein is deficient or faulty. Examples of this include the production of recombinant insulin for the management of diabetes and the production of recombinant erythropoetin for the treatment of anemia.
Alternatively, proteins may be ‘task-designed’ with a specific role in mind. Monoclonal antibodies (MAb’s) are one such example and are designed specifically to seek out cellular targets associated with certain diseases. trastuzumab for example is a monoclonal antibody designed to bind to the HER-2 receptor protein which is found in higher quantities on specific types of malignant tumors and is responsible for a more aggressive disease course. When trastuzumab binds to these cancerous cells they are effectively ‘tagged’ for destruction and removal by the body’s own defenses thereby using the tumors very own nature against it.
- Paul, J. and Lova, F. (2005), ‘Biotechnology – The new age ‘global’ industry’. Global Business Review, 6(2), pp. 315-321