Biomanufacturing

Biomanufacturing is the process of production of therapeutic drugs such as vaccines, proteins, gene therapies and cell therapies made from cells of living organisms (Smart, 2013). The companies that specialize in bioproduction use cells of living organisms to synthesize these amino acids, medicine (Langer 2012), vaccines and enzymes. To successfully carry out the process, the companies adopt strict regulations of operations of the machines and processes to be used (Smart, 2013). The processes require substantial hours of dedication by the employees and enough experience to carry out these processes successfully. Some of the processes involved in the manufacturing of these bioproducts include the culture of cells, chromatography, gene mapping and analytical testing of the molecular formulas of these drugs (Zhong, 2004). Some of the machines in use for biomanufacturing include reactor types such as hollow fiber, stirred-tank and rocking wave agitated bag batch. In biomanufacturing, all processes are important with none being superior to the rest. The process to be used is dependent on the different manufacturing capabilities such as the goal and requirements of the entire process or products.

Biomanufacturing has a rich history from the early times. The ancient people greatly practiced conventional forms of agriculture to ensure food production. With time, they discovered that there are certain organisms that can restore the fertility of the land. They applied this knowledge in alteration of the composition of plant material. Breeding of plants and animal cells started early in history and has undergone perfection to the 21st century where gene mapping and base DNA sequences of organisms are invaluable in biomanufacturing. In addition, fermentation was used in the early ages to produce beer from malt a process that is still being practiced up to date. These are some of the historical practices that formed the stepping stone to modern biomanufacturing where individuals can now use machines and computers to precisely manufacture or synthesize their desired product of choice (Calvert and Narayan, 2011).

Through biomanufacturing, pharmaceutical companies are now able to manufacture drugs (Langer 2012). These drugs contain molecules that are capable of binding to specific molecular agents to induce or stop certain biological processes (Smart, 2013). Biomanufacturing greatly uses microorganisms that are genetically altered such as yeast. It has recently emerged as a lucrative industry in spheres of biotechnology with many companies involved wanting to dominate the sector as it is promising. Numerous researches are being done on these bioprocesses to come up with new and better ways of carrying out biomanufacturing.

Biomanufacturing has blessed the human race. This is evident in a number of sectors where biomanufacturing is in use. For instance, through biomanufacturing, pharmaceutical companies are now capable of manufacturing drugs that are very effective in curing a wide array of diseases (Langer 2013). This would not have been possible without bioproduction as modern biomanufacturing uses computer-aided designs to manufacture precise products accurately in accordance with the desired specifications (Calvert and Narayan, 2011).

Biomanufacturing has advanced the cloning of organisms, especially in agriculture. These bio-manufactured crops have increased yield and better resistance to drought and diseases. The animals that have been cloned through processes of biomanufacturing are also much productive in dairy products or protein (Zhong, 2004). They also develop and mature at a faster rate. This achievement of biomanufacturing has ensured that food security is restored in many countries. Through biomanufacturing, countries are now able to sustain the growing food need of their citizens due to increased population and even export the surplus to generate revenue. The proteins in foods that have been biomanufactured have increased nutritional qualities. The proteins in legumes and cereals through biomanufacturing are converted into ready amino acids that supplement the protein requirement in human beings (Zhong, 2004).

The demerits of biomanufacturing include the high costs of carrying out some of these processes such as gene therapy. In addition, the personnel needed to complete these processes need to be sharp and knowledgeable to ensure they complete the processes well. This is key in explaining the reason biomanufacturing technology is focused on issues such as diseases that are common in the developed countries leaving out the developing states (Zhong, 2004).

The carriers of the genes and tools of delivery are preferably viruses. In the majority of the biomanufacturing processes, viruses are used as vessels of transporting materials to the required site of biological action (Langer 2012). The problem, however, is that viruses are the best-known vessels of transport and these may induce toxicity or infect the host altogether making the whole point of carrying out the bioprocess absurd. Another virus can also disrupt the endogenous genes of the host bringing more harm than good (Langer 2012).

Due to limited knowledge of the functions of genes, lack of precise machines and minimal research, many scientists still cannot outline precisely all functions of the genes (Langer 2012). Gene therapy, therefore, being a bioprocess in biomanufacturing and production is only capable of addressing particular genes that cause particular diseases. The lack of knowledge of the functions of genes creates uncertainties as scientists lack the assurance of the desirability of replacing these genes.

Biomanufacturing usually faces ethical issues and considerations from activists, bioethicists and governments (Zhong, 2004). This is specifically targeted towards biomanufacturing processes involved with gene therapy and germline therapy. The latter is responsible for changing the genetic makeup of the recipient’s descendants. It becomes detrimental if any error however minimal occurs during the process. These errors can also happen in natural means of reproduction but the risk is much greater in instances where artificial bioprocesses are introduced with consequences to be felt in case of errors in the process (Zhong, 2004).

Genetic tests on individuals with the aims of research reveal sensitive information about a person and their entire family (Langer 2012). This information is so sensitive in nature that it can affect the social relationships and institutions with particular emphasis on the family in case of leakage of such information.

The major challenge that biomanufacturing is facing currently is the high cost of carrying out the processes. Many organizations lack the funds to purchase machinery needed in successfully carrying out bioprocesses of biomanufacturing. In addition, this inadequacy of funds impairs the ability of organizations to undertake research that will provide meaningful insights to experts in the field. Lastly, the personnel who specialize in the field are few. These experts undergo intense study and training to perfect their knowledge and skills in this field. The majority of individuals who enroll for the course drop out leaving only a few to study, this not only happens in schools but also in the workplace where these individuals opt to leave these research centers to seek jobs in much simpler spheres of the industry.

Conclusion

Biomanufacturing is an important achievement of science in the 21st century. The process has its own merits such as synthesis of medicine (Langer 2012), providing food security and reducing the use of agrochemicals in agriculture to mention but a few. Even though this process comes with a blessing, it also has its own demerits and impacts on human beings such as the alteration of DNA. These negative impacts of biomanufacturing need to be addressed effectively to ensure that the process is of greater benefit than harm to the human race. This may be done by governments, schools, individuals and organizations funding rigorous research in the field to better the knowledge of experts and individuals.

References

Calvert, P., & Narayan, R. (2011). Computer-aided biomanufacturing. Weinheim: Wiley-VCH.

Langer, E. (2012). Biomanufacturing innovation. Pharmaceutical Technology Europe, 24(6), 16-16,18. Retrieved from http://search.proquest.com/docview/1441889352?accountid=458

Langer, E. (2013). Offshoring biomanufacturing. Pharmaceutical Technology Europe, 25(1), 37-38. Retrieved from http://search.proquest.com/docview/1285507905?accountid=458

Smart, N. J. (2013). Lean biomanufacturing: Creating value through innovative bioprocessing approaches.

Zhong, J.-J. (2004). Biomanufacturing. Berlin: Springer.