Biologics

by Shoshana Harlem, Terra Linda High School

Biologics are large and complex molecules that help to prevent,
cure, and treat various diseases. 

     Biologics are large and complex molecules that help to prevent, cure, and treat various diseases such as cancer, diabetes, chronic kidney disease, autoimmune disorders, and cystic fibrosis. They are composed of sugars, proteins, and nucleic acids. Biologics are also composed of living things such as cells and tissues. Biologics are produced from human, animal, and microorganism natural resources and are also produced by biotechnology methods.

Biologics are produced from bio-
technology methods, one of those
methods being genomics, which
involves studying the heredity material
of a cell in an animal or plant. Other
biotechnology methods used are
molecular markers, cloning, and
genetic modification.

Biotechnology describes processes and techniques that happen at the molecular level. There are different types of biotechnology applications including genomics, molecular markers, cloning, and genetic modification. Genomics involves the study of genes. When people study genomics, they study the heredity material of a cell in an animal or plant. Genomics help scientists to find the position and function of an animal and plant gene on a strand of DNA. Molecular markers are pieces of gene that are easy to detect. Molecular markers are helpful because they can be used to make DNA fingerprints of plants and animals which can help people identify what plant or animal they are. Another type of biotechnology application is cloning, which is when genetically identical organisms are produced. Instead of genes being modified, genes are copied.  Then there is biotechnology application is  genetic modification which involves modifying the genetic material of an organism by introducing, moving, or adding specific genes. An example of genetic modification is when scientists take a gene from one plant or animal and put it in another plant or animal so that organism can have a desired characteristic.

There are many types of biologic drugs and one of those
drugs is vaccines. Vaccines are important because they help
an immune system produce antibodies which helps prevent diseases.
Other types of biologic drugs include antibodies and vaccines.

     There are many types of biologic drugs including antibodies, interleukins, and vaccines. When the body's immune system finds foreign substances, called antigens, it produces proteins called antibodies. Each antibody is unique because it helps fight off a specific type of antigen. Some examples of antibodies include microorganisms such as bacteria, parasites, fungi, and viruses. An autoimmune disorder happens when an antibody is produced when there is actually a healthy tissue but the immune system mistakenly believes that is a harmful substance. Interleukins are a type of cytokine (which are substances produced by the cells of the immune system that have an effect on other cells) that help to influence growth and activate during immune and inflammatory responses. The proteins in interleukins can cause many different reactions in cells and tissues. Vaccines helps an immune system produce antibodies and they are powerful because they help prevent diseases. When a person is vaccinated, they become immune to that disease.

The FDA has roles regarding biologics such as teaching
the public how to safely use biologics, inspecting products
before they are improved, and making sure that biological
products are safe. 

     The (U.S.) Food and Drug Administration (FDA) has responsibilities when it comes to biologics. They look at new biological products and determine whether they should be produced or not. The FDA also helps figure out ways to prevent infectious diseases from spreading. A third thing that the FDA does is demonstrates to the public how to use biological products safely and appropriately. They inspect plants that manufacture biologics before the product is approved. They make sure that biological products are safe.

Licensed biological manufacturers must follow laws

related to biologics, and report and fix problems with

biological products.

     In addition to the FDA, licensed biologics manufacturers also have responsibilities when it comes to biologics. They have to make sure that they follow laws and regulations that relate to their biologics' license, and identify changes that should be made in order to have better product quality. When there is a problem, it must be reported by the licensed biologics manufacturer to the FDA's Biological Product Deviation Reporting System. A problem must be reported and corrected during the established time frame. When there is a serious problem with a biological product, the licensed biologics manufacturers must stop creating that product.

     To learn more about biologics, come to the Marin Science Seminar at Terra Linda High School in room 207 from 7:30PM-8:30PM on Wednesday, February 26, 2020. Terry Hermiston, Ph.D. of Coagulant Therapeutics and GlAdiator Biosciences will be speaking. Join us and learn!

Sources:
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers
https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf
https://www.fda.gov/consumers/consumer-updates/fda-101-regulating-biological-products
https://medlineplus.gov/ency/article/002223.htm
https://www.ncbi.nlm.nih.gov/books/NBK499840/
https://www.cdc.gov/vaccines/vpd/vpd-vac-basics.html
https://hsci.harvard.edu/translation/what-are-drugs-3-biologics
https://www.usda.gov/topics/biotechnology
http://agriculture.vic.gov.au/agriculture/innovation-and-research/biotechnology/what-is-biotechnology