English 341

Dr. Leslie Bruce

BIOLOGICAL PRODUCTS
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By Randy Navarette

Researcher preparing CEA cancer vaccine. This vaccine combines a virus found in canaries with human
genetic material. [1,15]

INTRODUCTION
Biological Products are a category of medical innovations in which a primary component of the

manufactured material is derived from living organisms. The applications of these semisynthetic

products are vast and varies in complexity from simple procedures to life saving techniques.

Recipients of these bioengineered substances can be either human or animal. The source material

of the biological products can be anything defined as living and all levels of biological taxonomy

are utilized for composition of the biological products. [2]

Etymology/History

Biological product is a neologism beginning to enter into common vernacular circa 2020 with the

FDA stepping in to add an official definition to create standardization and aid in the transition

away from related but outdated terms such as biopharmaceutical or biologics. [3] Parameters for
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these products which are in effect drugs and as drugs subject to heavy government protocols

surrounding their use, manufacturer and distribution. [4]

Historical usage dated to antiquity with 2000-year-old mummies testing for therapeutic levels of

the compound tetracycline, sourced from mold, commonly used to treat infections even in

modern times. Theories point to the ancient cultural consumption of beer as the likely source of

the microorganism. [5] Since these biological products were the first type adapted for usage by

humankind they have lost their effectiveness and new developments seek to rejuvenate these

techniques through ongoing technological advancements. One such method currently being

refined is fecal microbiota transplants i.e. transplanting of the gut flora from a healthy individual

to another suffering with an infection known as c. difficile. [6]

Types of Biological Products

Since the term is a catch-all for anything extracted from a living biological source, then used in a

medical scenario, a biological product will invariably fall within one of the four following

categories.

a. Direct from Source with Minimal Alteration:

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Images used by permission from creative commons. [7, 8, 9, 10]

Organs used for transplants, breast milk, blood, and stem cells are all examples where the

biological product is removed from one living organism and directly issued to, transplanted,

injected or placed into another living organism for its benefit. [10]

b. Derived from Genetic Sources:

[11]

In contrast to the simplicity of a biological product such as breast milk, the biological products

derived from genetic material are much more complicated in scope and require laboratory

equipment, molecular cloning, usage of viruses as vectors and advanced scientific training. An

example in this category would be insulin used by diabetics. [12]

c. Cultured on Tissue
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Stem cells engineered to grow cartilage. [13]

Mentioned previously, stem cells prove to be one of the most versatile biological products. While

they can be used unaltered and directly injected into areas of the body in need of repair they can

also be used as the medium for growing other tissues which will then be grafted or transplanted

as needed. [14]

d. Viral Manipulation:

Viruses found in nature are combined with human genetic material to create vaccines. The virus

is not harmful to humans and when modified in a laboratory creates a protein which can aid in

cancer treatment. [15]

Regulation and Possible Moral Implications

In the United States the FDA essentially classified biological products as drugs and regulates

them as such. [3] The European Union follows similar guidelines as does Canada monitoring

conducted by each country's health organizations. Much of the controversy surrounding

biological products centers around two areas: stem cells and organ transplants. Like all products,

biological products are not free from a black market. Illicit organ sales coupled with the almost

urban legend status of illegally harvested organs adds a dark tone to the otherwise hopeful

prospects of the synthetic creations. Similar in concern are fetal stem cells and their origin.
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Groundbreaking science has always made humanity question itself, question what it claims as

truth and righteousness. History has shown that science is usually on the winning side despite

public opinion and shifting morality.

References
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[1] Photo by National Cancer Institute on Unsplash.

https://unsplash.com/@nci?

utm_source=unsplash&utm_medium=referral&utm_content=creditCopyText

[2] Bucar, Franz, Wube, Abraham, & Schmid, Martin. (2013). Natural product isolation -

how to get from biological material to pure compounds. Natural Product Reports, 3(4), 525–545.

https://doi.org/10.1039/c3np20106f

[3] Flint, Daniel L, & Shelton, Deborah M. (2018). FDA FORMALLY ANNOUNCES

RULEMAKING TO AMEND DEFINITION OF BIOLOGICAL PRODUCT. The SciTech

Lawyer, 14(3), 38–40.

[4] Wang, Wang, Wei, & Manmohan Singh. (2013). Biological drug products: development

and strategies. Wiley.

[5] Armelagos, George J. (2000). Take Two Beers and Call Me in 1,600 Years.(use of

tetracycline by Nubians and Ancient Egyptians). Natural History, 109(4), 50.

[6] Hagel, Stefan, Stallmach, Andreas, & Vehreschild, Maria. (2016). Fecal Microbiota

Transplant in Patients With Recurrent Clostridium Difficile Infection. Deutsches Ärzteblatt

International, 113(35-36), 583–589. https://doi.org/10.3238/arztebl.2016.0583

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[7] "National Guard Kidney Transplant 1" by North Dakota National Guard is licensed with

CC BY-NC-SA 2.0. To view a copy of this license, visit

https://creativecommons.org/licenses/by-nc-sa/2.0/

[8] "20141106_181641" by J.Michelle.E is licensed with CC BY 2.0. To view a copy of this

license, visit https://creativecommons.org/licenses/by/2.0/

[9] "Blood Bag, In 'NO FLASH ALLOWED!' Conditioning" by spike55151 is licensed with

CC BY-NC-SA 2.0. To view a copy of this license, visit

https://creativecommons.org/licenses/by-nc-sa/2.0/

[10] "Neural stem cells" by CodonAUG is licensed with CC BY 2.0. To view a copy of this

license, visit https://creativecommons.org/licenses/by/2.0/

[11] "Flu Vaccine: Reverse Genetics" by NIAID is licensed with CC BY 2.0. To view a copy

of this license, visit https://creativecommons.org/licenses/by/2.0/

[12] Definition of the Term "Biological Product" (2020). In The Federal Register / FIND

(Vol. 85, Issue 35, p. 10057). Federal Information & News Dispatch, LLC.
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[13] "Stem cells engineered to grow cartilage" by National Institutes of Health (NIH) is

licensed with CC BY-NC 2.0. To view a copy of this license, visit

https://creativecommons.org/licenses/by-nc/2.0/

[14] Hallman, Mats, & Thor, Andreas. (2008). Bone substitutes and growth factors as an

alternative/complement to autogenous bone for grafting in implant dentistry. Periodontology

2000, 47(1), 172–192. https://doi.org/10.1111/j.1600-0757.2008.00251.x

[15] Sánchez-Sampedro, Lucas, Perdiguero, Beatriz, Mejías-Pérez, Ernesto, García-Arriaza,

Juan, Di Pilato, Mauro, & Esteban, Mariano. (2015). The evolution of poxvirus vaccines.

Viruses, 7(4), 1726–1803. https://doi.org/10.3390/v7041726

wrap up paragraph: This was challenging and fun. The partitioning helps just to keep things

organized when assembling the paper. This normally would have been an issue as so much

information can become overwhelming but the partioning acted as a template/guide. The

graphics help bring the paper to life and its hard not to go overboard hopefully I kept it tasteful. I

aimed for the look of these science encyclopedias I would read as a kid. Looking back I should

have tried to use negation more let people know what the keyword is NOT as it covers so much

ground. I hope you like it! Thanks for reading! (And teaching!)
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