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ISSUES INVOLVED IN PRE-CLINICAL EVALUATION OF BIOTECH PRODUCTS

Biotechnology entails the genetic modification of living organisms, so as to fit desirable traits. The desirable characteristics could be tolerance to disease, increased yield or output, early maturity periods, tolerance to weather, among other advantages. The desirable gene is injected into the system of a host organism so that the host organism acquires the desirable traits. The benefits of biotechnology are numerous, ranging from high tolerance to diseases, tolerance to weather and to considerable improvements in yields. In the recent past, biotechnology has changed the face of the earth. Today biotechnology is used to produce agricultural products that ensure food security. Genetically modified products are penetrating into the market.

However, there have been concerns that biotechnological products pose health issues. In this regard, some of the modified products have not been allowed to penetrate into the market. Clinical tests have had to be conducted on the safety of some of these products. Countries all over the world have varied opinions on the use of biologically modified products. While some think that they do pose health threats, others see biotechnology use as a way to acquire food security, especially with regards to the changing climatic conditions (Katz & Sattelle 1990). Biotechnology, depending on the tools and procedures used, sometimes overlaps with biomedical engineering and bioengineering.

Biotechnology finds many applications in food production, medicine and agriculture. The recent past has witnessed diverse fields like applied immunology, recombinant gene technology, pharmaceutical therapies, diagnostic tests and genomics.

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Definitions of Biotechnology

Biotechnology comprises of a broad procedural range of procedures for modifying organisms according to human purposes. Modifications range from traditional methods, like hybridization and artificial selection, to modern tissue culture technology and genetic engineering. It involves the improvements in value of materials like pharmaceuticals, livestock and crops. It also borrows from pure biological sciences like microbiology, genetics, cell culture, embryology and molecular biology. In many instances, biotechnology borrows from bioprocess engineering, chemical engineering, and information technology and bio robotics.

Modern biological sciences, like molecular ecology, are related heavily to fields like tissue engineering, genetic engineering and pharmaceutical engineering.

History of Biotechnology

Contrary to beliefs that biotechnology exists only in recent times, biotechnology is as old as man. In agriculture biotechnology was used in choosing the best seeds for improved yields. When lands became less fertile farmers resorted to use of manure and nitrogenous crops like beans and groundnuts that have natural nitrogen fixation. In recent developments farmers use manufactured fertilizers to improve crop yields. In animal husbandry, farmers have been known to consider crossbreeding in a bid to improve or acquire the best breeds. From traditional times grains and yeast have been used as catalysts to speed up the process of fermentation in beer making. In the process of fermentation, carbohydrates are broken down into alcohol, mostly ethanol and carbon dioxide. Yeast has been used in leavening bread. Lactic acid has been used in preservation of soya seeds. Pasteurization borrows heavily from biotechnology. Penicillin as a drug was discovered using the principles of fermentation.

Applications

Biotechnology has four wide applications in crop production and agriculture, non-food uses, healthcare and environment.
Bioleaching makes use of naturally available bacteria in mining industries. Biotechnology is used to recycle, treat and reuse waste materials that would otherwise be non-biodegradable waste.
Biotechnology is used in manufacturing of organic products like milk and beer. Biotechnology is also used in the production of biological weapons.
A number of derived terms are bioinformatics, blue biotechnology, green biotechnology, red biotechnology and white biotechnology.
In medicine biotechnology find applications in pharmacogenomics, drug production, gene therapy and genetic screening. Genetic screening can be used to test symptoms of amniocentesis, CVS and Down syndrome.

Pharmacogenomics

This is the study on how genetic code of an individual affects his/her response to drugs. The study aims at understanding the relationship between drugs and genetics and how drugs that adapt to different genetic codes can be manufactured. Pharmacogenomics helps in studying DNA and RNA structures of different individuals and come up with tailor-made drugs that adapt to specific diseases and genes. These drugs have low side effects and do not damage nearby tissues and cells. This field of medicine will help doctors determine recommendable drug doses to patients. Studying genetic structure of an individual helps in establishing how different individuals respond to different drugs, so that doctors will prescribe only the recommended doses that will lower instances of overdose.

Pharmacogenomics helps in drug discovery and approval. Discovery of potential therapies will be made possible by the use of genome. Genes that have been associated with many disorders can be manipulated genetically to produce drugs for a range of therapies. Genetic engineering will help in producing vaccines based on stem cell cultures taken from many individuals. These vaccines will initiate immune responses in individuals for disease prevention.

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Biotechnology finds many applications in crime management. Today due to forensic science it is possible to determine the DNA of a criminal, who committed an offence by comparing their DNA structure to DNA found on a smear left at a scene of crime (Wells 1996). Forensic surgery is also used to determine a cause of mysterious deaths. These are cases where a cause of death is unknown. Through engineered medical forensic programs it is possible to link DNA evidence left on victims’ bodies. Genetic engineering can be used to determine sex of an individual. Biotechnology can be used to improve quality of crops and animals. In the modern society, biotechnology has achieved milestones in areas where natural methods have failed. There are now prospects of food security since it is possible to genetically engineer new species of crops that hold the promise of better yields. This is crucial especially in this era of global warming and changing climatic patterns. Biotechnology has made it possible to use a greenhouse. We are talking about economy of land. Whereas huge tracts of land were used for crop production and animal rearing in biotechnology, through the use of controlled environments such as green house, small tracts of land can be manipulated to produce maximum output.

Different more resistant strains can be developed for more output. In pharmacy, biotechnology has made it possible to produce compatible drugs to patients’ conditions. This is possible by studying the DNA structures of different individuals and diseases. Based on gene structures, drugs that are more compatible to diseases are introduced. This minimizes the case of non-compatibility of drugs or cases of grave effects if the wrong drug is used. Findings in biotechnology has made it possible to develop life prolonging drugs or vaccines that are used to prolong lives like in the HIV cases or vaccines like typhoid vaccines and malaria vaccines. These vaccines derive their usage from the genetic code of individual carriers of diseases. The strains of these diseases are introduced in controlled amounts into an uninfected individual’s system. The immune system gets used to a disease so that when a person is infected there will be a minimal effect as the receptors of the disease within the individual’s system are weakened. Biotechnology today is applied in many fields.

It is expected that biotechnology will go beyond the industrial unit and study centers influencing our ordinary lives. Biotechnology has, for instance, made such infections like Sickle Cell Anemia, Tay-Sachs syndrome, diabetes, Cystic Fibrosis etc. conceivable to identify, and in most cases to treat. Succeeding initial anxieties that hereditary engineering might give rise to disease-causing organisms, a strict set of strategies was set up with the government and top scientists in the mid-1970s to regulate study in this field. Whereas it is not likely to eliminate totally the risk of accidents of genetic engineering, the experiences of the last decades have shown that the probabilities of making a disease-producing organism by mishap are very remote. This is because such pathogens require an extremely complex set of divergent features, and are operational only when everything is present. Here is a case that gives an insight into genetic engineering:

Mrs. Rita Trosack’s case is one of genetic conditions when diseases are passed down from generation to generation. This usually occurs with some probabilities. Advancements in the medical field now make it possible for affected members to perform screening tests so as to be able to know if one has a genetic condition. It is important, in fact vital, for people to know past medical histories of family members, diseases that affected your parents, your maternal and paternal grandmothers and grandfathers, even close members of the family. These medical histories help doctors ascertain, to some degree, the possibilities of genetic diseases recurring in future generations within the same family lineage. Biologically, genetically to be precise, genes of a parent are replicated in his/her offspring. Some of these genes contain hereditary conditions that are bound to be passed to future generations, albeit with some determinable probabilities. Mrs. Rita is no exception. Tay-Sachs disease is a genetic condition that results when hexosaminidase A, a protein charged with breaking down gangliosides, found in nerve tissues, lacks from the body. Deficiency of hexosaminidase A causes a build-up of ganglioside GM2 in body cells, mostly in brain cells.

Tay-Sachs condition is caused by a defective gene on chromosome 15 causes. When each member of a couple carries the defective Tay-Sachs gene, a child has a 25% probability of acquiring the condition. The child has to obtain two copies – each from both parents – so as to be infected. If just one of the parents passes the defective gene to the child, the child is called a carrier. It means that the child is NOT sick, but he/she has the potential to pass over the disease to their offspring. Although anyone can be a carrier of Tay-Sachs, the disease is mainly common among the Jews, with about one in every twenty-seven being carries of the rare gene. Tay-Sachs is classified into three categories: infantile, juvenile and adult, largely dependent on the initial symptoms. Infantile Tay-Sachs is the most common. Here, damage to the nerve starts when a baby is in uterus. Symptoms appear from the age of three to six months, and include deafness, blindness, wasted muscles, mental slowness, dementia, seizures, paralysis, and retarded growth, among other less serious symptoms. This is a case study based on a hereditary condition.

After listening to Mrs. Rita Trosack’s case and studying her family medical background, I decided to form an interdisciplinary team to help get more information after the first visit. The team would consist of Rita and her husband, Dr. Zimmerly, and of course me. Rita and her husband present a lot of information on their family backgrounds.

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From my conversation with Rita, I was able to deduce the following:

  1. Rita conceived after two years of trying, which is, to some extent, normal.
  2. Her advanced maternal age prompted Dr. Zimmerly, her Physician to perform chorionic villus sampling (CVS) on her.
  3. Though Rita’s paternal grandparents are deceased, they had two children, one of whom died at an early age, probably infancy, due to unknown causes.

Her husband’s story also came in handy as it was able to reveal that he too had a maternal grandmother, who had three children. Two of them, a boy and a girl, died at an early age, of unknown conditions. These early deaths could only point to a genetic condition. Dr. Zimmerly’s inclusion is very important as he is the one who suggested the CVS test for any genetic defects on Rita’s unborn baby. As a high risk obstetric nurse charged with this case, I must get all necessary information like studying her and her husband’s family backgrounds, to extract any evidence of past medical conditions (Arora & Kanta 2007). Rita and Peter Trosack provide vital information, especially after the striking resemblance in nature of deaths of their grandmothers’ children. It strikes me that the children died at very tender ages, a fact that, owing to available medical statistics, point to Tay-Sachs genetic condition. Dr. Zimmerly’s role cannot be overstated. His recommendation for a CVS test plays a very pivotal role in this case. The fetal genetic results suggested positive for Tay-Sachs. Without his recommendation, the referral would not have been possible. His advice on the dos and don’ts of pregnancy were well placed, considering that pregnancy period requires a lot of exercises for a mother and an unborn baby. Alcohol intake is dangerous to fetus, as well as to mother, facts that were well emphasized by Dr. Zimmerly.

After explaining some basic facts about the disease to Rita, like the symptoms, and the expected life span of the disease (Born children hardly live beyond four years of age), I embarked on a teaching plan to help the couple regain hope and rationality in dealing with their situation. I took Rita through diagnosis of Tay-Sachs. Usually if the disease is suspected, a medical practitioner shall perform physical examination, during which he/she must interview a patient about his/her family history. The doctor may perform additional tests, including: enzyme study of blood or tissues of the body for hexosaminidase levels. These analyses help the doctor ascertain the extent of damage on the brain cells. Eye examination may also be necessary as it reveals red sports in specialized and central area of retina. These cherry-red spots could mean that a patient is sick. Although, currently, the disease has no known cure, there are a number of ways that can be used to manage the symptoms.

There is no treatment or cure for Tay-Sachs disease but there are ways to manage symptoms. These measures include usage of feeding tubes on an infected child and massaging the baby to make him/her feel comfortable. Gradual loss of ambulatory skills, then respiratory health and management of seizures are problematic areas in juvenile Tay-Sachs. However, recommendations for symptom management are well explained in Tay-Sachs support .The symptoms of Tay-Sachs worsen with time, with children, who suffer from the disease, dying by age of four or five. Newly diagnosed families are advised to join support groups such as NTSAD (National Tay-Sachs and Allied diseases) as it helps parents form care plans and goals towards the disease. Complications of Tay-Sachs; symptoms appear during the first three to four months of life, then progress to seizures, and loss of muscle co-ordination.

The following measures will help in case your child experiences seizures lasting more than two minutes:

Call local emergency numbers such as 911 or call for an appointment with a child’s health care provider. Signs of pregnancy may include missed menstrual periods, feeling nausea, morning sicknesses, tender breasts and vomiting. Pregnancy is a sensitive period that demands proper rest, good posture, diet, lots of fluid and exercises (Lerner & Lerner 2012). There are ethical implications of personal genetic information. Whereas knowing one`s genetic information is good for the health and well-being of the society, it poses ethical challenges for pragmatic considerations. For instance, clinically, pragmatic considerations facing health experts are how to come up with some of the best methods to offer genetic services. Ways of gathering relevant information from individuals according to their family histories of health and diseases can assist in knowing those who benefit through referrals. People also need to agree on how, and with what to get tested. Access to referrals, for instance, genetic testing for hereditary predispositions to leukemia is pegged on resources and finance for such services. (Touchette, Holtzman,& Feetham 1997). Decisions such as where, how, when, and by whom should testing be offered need to be made. The Trosacks wanted to have a child at all costs. It did not matter to them whether the child would only live for a few years. This irrational decision only serves to show their emotional attachment to their baby. The society needs to be open to such issues as legal and ethical implications of genetic information. Nurses need to be taught to be receptive to affected and infected individuals.

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Dried plants stalks and leaves and animal wastes like cow dung can be collected, put into digesters and fermented to produce gas. They can be transformed into fibers and industrial biofuels. These fuels can be made from plants like sorghum, bamboo, palm trees and eucalyptus. Specifically grown products are used to produce energy. They are grown on wide scale and they produce high biomass per acre with a low energy input. Examples of these grown substances are wheat and straws. They find wide scale application in countries like the UK and USA. A typical one hectare field produces up to 7.8 tons of biomass. Straw produces approximately 4 tons of biomass. Wheat grain is used as fuel transportation liquid while straw is directly burned to produce heat and electricity. Plant products can also be converted through a series of reactions from cellulose to glucose. The glucose is then fermented to produce biofuel.
Waste-to-energy process is the largest source of energy. Wastes come from industries, municipalities, landfills and waste products from homes. Landfills are hollow, shallow or deep sites that wastes are dumped into. These wastes decompose, ferment and release gas, especially methane. Through controlled processes, this gas can be harvested for use. Energy can also be derived from left-overs at home. Collected waste is put into digesters for fermentation to produce biofuel.

Used as gas, methane provides cheap source of energy. Biomasses are also converted into biofuels like biodiesels, used as transportation liquid fuels. Decomposing garbage, human and agricultural wastes ferment naturally to release methane gas. Grown crops are harvested, processed and converted through standard processes to produce biofuels like biodiesel.
There is a research conducted on the large scale use of alga as a source of energy. Considering that alga can produce 5 to 10 times equivalent of energy compared to wheat and corn, alga is surely the next biggest source of energy. If fermented, it holds the promise of producing hydrogen and biodiesel (Somani 2005). It is projected that alga biomass will be commercially produced. It could be also used as a by-product in rather complicated processes to produce biofuel. The ultimate goal is to produce a wide scale cheap and environmentally friendly energy. Approaches like genetic engineering will come in handy.

There is a need to educate people on how to produce biofuels at least domestically. Left-overs can be collected and fermented to produce energy. Waste products from poultry and cattle, if well fermented, hold prospects for an alternative energy source.

Thermal Conversion

Thermal conversion processes use heat mechanism to transform biomass into chemical form. Main thermal alternatives that are currently available are combustion, pyrolysis, torrefaction and gasification (Cassedy 2003). The differences in these conversion techniques lie in extent and control of chemical reactions in each category. The amount of oxygen and the variation in temperature are the dynamics that make them different from each other.

When biomass is burned directly, like burning wood directly to produce heat, the resultant energy is called dendro-thermal energy. This kind of energy is characteristic of tropical countries that have dense forests and canopies, so that wood is readily available (Arora & Kanta 2007). Other unfamiliar, even experimental thermal conversion processes offer benefits like hydro-processing and hydrothermal upgrading.

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The Issues of Biotechnology

The precaution with which experiments are carried out is the key to producing safety products. Scientists in the area of microbiology have valuable experience on how to handle dangerous viruses like small pox and bacteria like cholera (Wells 1996). Prevention by use of sterile and airtight equipment is supported by biological measures to control the disease. Some of the strains do dot survive outside the human body. Fears of biological warfare are now quelled with the up-to-standard policies in place (Lewis 2007). However, it is surely an overwhelming aspect of the utilization of biotechnology that requires continued attention.

The Safety of Biotechnology

Despite the successes and the great prospects biotechnology has had, there has been a major concern about the future of genetic engineering as a branch of biotechnology. Scientists’ worries about the safety issues have been a major concern in the recent past. Special committees were set up to review the issues of bringing genetically engineered organisms into the market. This has been possible through the use of recombinant DNA technology (Smith 1996). They unanimously agreed that the presence of these genetically engineered organisms do not pose a threat as such. The RNA and DNA structures do not change the human system in any way as was previously believed. The conclusion is that rRNA and rDNA techniques pose no serious threats.

Biotechnology and Legal Implications

It is critical that these issues are discussed in public deliberation with the development of technology. Several countries are aggressively reviewing the ethics and safety of biotechnology and its uses. Certain states have already recognized research strategies for work on embryonic transplantation, embryonic research, and alternate motherhood. Barristers and the citizens shall be expected to answer to these challenges and related questions while the biosciences, as well as biotechnology, move forward.

Legal complications have emerged concerning patent laws. For example, in 1980, a court in the U.S reversed existing exercise and administrated those genetically-engineered microbes as patented.

Benefits

Potential benefits consist of resolving world food insecurity and medical improvements, veterinary sciences and agriculture (Messina 2000). People can confidently anticipate biotechnological answers to many important industrial processes which currently produce poisonous effluents. A growing starring biotechnological role is environmental management. Since the prospects of severe biohazards appear to be ebbing, this does not imply that strict regulations of this innovative technology ought to be compromised. Given that watchfulness is retained, people can start considering a wide choice of stimulating prospects stemming from biotechnology.

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