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Biotechnology products
Introduction
Biotechnology refers to the manipulation of organisms, living system or parts of the
living organism to make products, environment or system for the benefit of human beings. The
product that may be made by biotechnology process may include; pharmaceuticals, foods and
water purification (Biotechnology Learning Hub, 2010). However, it has various definitions
since it involves mixtures of disciplines, such as physiology, genetics, medicine and bioprocess
engineering, thus, simple definition of biotechnology is manipulation of organism scientifically
at a molecular level in order to come up with productive products for human use (Zoon &
Garnick, 2012).
Types of Biotechnology products
Medical biotechnology
This involves the use of biological substances like enzymes or bacteria in manufacturing
industries to produce synthetic hormones and drugs. The knowledge of Medical Biotechnology is
widely employed in preventing and combating the variety of diseases that attack human beings.
The cell materials are useful in research and production of pharmaceutical products used in the
eradication of the human disease. Some of the well-known inventions of Medical Biotechnology
are growth hormone and insulin, Alzheimer’s syndrome and Parkinson’s diseases are easily
cured with the help of genetic engineering (biotechonweb, 2014).
Agricultural Biotechnology
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The knowledge is well employed in Molecular makers, Genetic engineering, Vaccines,
tissue culture and Molecular diagnostics. For instance, tobacco is manipulated to produce an
anti-lymphoma vaccine, this is later used to vaccinate and boost the immune system of the
patient against cancer. Also, most plants are used in the production of antibiotics for both animal
and human use. This method of acquiring antibiotics from plants for human use has several
advantages in that it involves the massive production of products from plants in a fermentation
unit, have a low risk of contamination and they are easy to be purified as compared to when
using culture media and mammalian cells.
In addition, the field of Biotechnology is well used in crop and animal production. It is
possible to transfer genes to other crops so as to introduce new characters that can be able to
reduce the crop vulnerability to pathogen attack and environmental stress, increase the yield and
improve the taste by use of techniques of modern biotechnology. On the other hand, animal
biotechnology is used in the processing of materials by animals, for example, generation of
transgenic animals (Types of Biotechnology, 2013).
Industrial Biotechnology
It involves using fungi, algae, plants, and micro-organism and marine organism in
industrial application. For instance, the oldest application of industrial biotechnology is
knowledge of bread making. In this, the gluten proteins provide visco-elastic properties to wheat
dough, thus, it is able to trap the released carbon dioxide from the yeast that gives rise to porous
structure (Shwry, Tatham, Barro, Barcelo, & Lazzeri, 2010). The application of biotechnology
in the industry has become enormous worldwide; this is because it has given the opportunity of
using renewable resources without depleting them, causing a negative problem to the quality of
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life and degrading the environment. In addition, it is possible to design products that are difficult
to achieve by use of conventional petroleum or chemistry as feedstock. More intense application
of industrial biotechnology includes; extraction of enzymes from plants and microorganism that
are later used to catalyze chemical reactions, in comparison with chemical processes,
biologically catalyzed process consumes less energy, requires less organic solvent and their
waste production is low. Also, enzymes are used to process fiber that will have otherwise used a
lot of water, energy and chemicals to treat them so as to make papers and textile products
(OECD, 2013).
Formulation of Biotechnology products
Formulating of a product refers to the way of creating something through careful thought.
Formulation of a biotechnology product entails taking the purified protein that has desired
concentration and then it is dispensed with proper excipients that are able to ensure the integrity
and product quality during the finishing steps such as filtration, lyophilization, filling, packaging,
transport and delivery (Rathore & Rajan, 2008). Formulation procedures are as follows: Bulk
Freeze-Thaw mostly employed in biopharmaceutical manufacturing in order to gain operational
flexibility while the quality of the product is maintained. Frozen drugs are advantageous over
liquid stored in that there is the possibility of reducing microbial growth and increasing
instability of the product. For instance, the drug substances are in a frozen storage form and they
are transported to the fill site where thawing takes place, thus initiating formulation and finish
steps. The detailed steps during formulation step are as follows: after thawing, the bulk is
formulated with right buffer and to the desired concentration; this involves the addition of the
excipients at the desired concentration and adjusting conductivity, pH, and concentration. When
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buffer exchange between drug product and drug substance is required, UF/DF steps are
employed.
After formulation steps, drug substances goes through sterile filtration steps. This step is
performed by 0.22µm filter; this ensures that the bulk is free from the microorganism. In case of
filter failure, dual filtration is employed. However, performing this step at a high trans-
membrane pressure can pose a stress to protein. The last step in drug development is drug
product filling, this involves filling into the drug product containers that are vials for prefilled
injectables. Before this process, plungers, stoppers, and containers need to be sterilized
separately and combined together under aseptic conditions. However, the issue of maintaining
sterility of the drug is a crucial factor since there is no further sterilization of the drug product
(Harri, Shire, & Winter, 2004).
After the drug has been established, it is important that its long-term and short-term
effects be made on the cells and organs, also, specific information for example; the reaction
effect of drugs on pregnant mothers should be established and the most important information
should be on routes of application of that drug, whether oral or through injection. In addition,
dosage application in relation to varying conditions should be stated, for example, the number of
dosages depending weight and age of the person receiving the medication and lastly the
metabolic fate of the drug and means of its elimination should be studied (Allen, Popovich, &
Ansel, 2009).
Conclusion
Biotechnology is an important discipline in the current world for its enormous application
from industry, agriculture to pharmaceuticals. For instance, more products has been developed
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which have helped to raise the living standard of human being, although various controversial
have accompanied the field more so in relation to GMO though no evidence has proved the
adverse effect to having arisen from the use of the products. However, it is vital to appreciate the
work of biotechnologist, mostly in the field of pharmacy, since more diseases that used to be a
threat to the human being have been successfully eradicated by the new inventions made. For
instance, long time ago, insulin dependent people relied mostly on the animal insulin which had
an allergic reaction to the recipient, nowadays, they receive human insulin produced by cloning
human gene with a recombinant bacterium.
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References:
Allen, L. V., Popovich, N. G., & Ansel, H. C. (2009, October 22). ANSEL'S -Pharmaceutical
Dosage forms & Drug Delivery System. Retrieved February 13, 2016, from Slideshare:
http://www.slideshare.net/JaveriyaAnsari/ansels-44305212
Biotechnology Learning Hub. (2010, February 01). Definitions of biotechnology. Retrieved
February 12, 2016, from Biotechnology Learning Hub:
http://biotechlearn.org.nz/themes/what_is_biotechnology/definitions_of_biotechnology
biotechonweb. (2014, March 21). Brief introduction about Biotechnology:. Retrieved February
12, 2016, from biotechonweb: http://www.biotechonweb.com/types-of-
biotechnology.html
Harri, R. J., Shire, S. J., & Winter, C. (2004). Commercial manufacturing scale formulation and
analytical characterization of therapeutic recombinant antibodies. Drug Development
Research, np.
OECD. (2013, April 2). THE APPLICATION OF BIOTECHNOLOGY TO INDUSTRIAL
SUSTAINABILITY – A PRIMER. Retrieved Feb 12, 2016, from OECD:
http://www.oecd.org/sti/biotech/1947629.pdf
Rathore, N., & Rajan, R. S. (2008). Current Perspectives on Stability of Protein Drug Products
during Formulation, Fill and Finish Operations. Biotechnology Progress, pp 504-514.
Shwry, P., Tatham, A., Barro, F., Barcelo, P., & Lazzeri, P. (2010, November 13).
Biotechnology of breadmaking: unraveling and manipulating the multi-protein gluten
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complex. Retrieved February 12, 2016, from PubMed:
http://www.ncbi.nlm.nih.gov/pubmed/9636290
Types of Biotechnology. (2013, December 22). Retrieved February 12, 2016, from environment:
http://www.environment.gov.ls/documents/Recent_Publications/Types_of_Biotechnolog
y_Brochure.pdf
Zoon, K., & Garnick, R. (2012, March 23). Definition of a well-characterized biotechnology
product. Retrieved February 12, 2016, from NCBI:
http://www.ncbi.nlm.nih.gov/pubmed/9890531