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'''Biologics''' are a category of medical products derived from living organisms. They include a wide range of products such as vaccines, blood components, gene therapies, tissues, and recombinant proteins. Biologics are used in the prevention, diagnosis, and treatment of various diseases and medical conditions.<br />
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== History ==<br />
The development of biologics dates back to the late 19th century with the advent of [[vaccination]]. The first biologic product was the smallpox vaccine, developed by [[Edward Jenner]] in 1796. Since then, the field has expanded significantly, especially with the advent of [[recombinant DNA technology]] in the 1970s, which allowed for the production of complex proteins and monoclonal antibodies.<br />
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== Types of Biologics ==<br />
Biologics can be classified into several categories based on their source and function:<br />
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=== Vaccines ===<br />
Vaccines are biological preparations that provide immunity to a particular infectious disease. They contain agents that resemble a disease-causing microorganism and are often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins.<br />
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=== Blood and Blood Components ===<br />
These include whole blood, red blood cells, platelets, and plasma. They are used in transfusions and to treat various blood disorders.<br />
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=== Gene Therapy ===<br />
Gene therapy involves the introduction, removal, or alteration of genetic material within a patient's cells to treat or prevent disease. This innovative approach holds promise for treating genetic disorders, some types of cancer, and viral infections.<br />
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=== Recombinant Proteins ===<br />
Recombinant proteins are proteins that are engineered in the laboratory through recombinant DNA technology. Examples include insulin, growth hormones, and monoclonal antibodies.<br />
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=== Tissues ===<br />
Biologic tissues are used in transplantation and include skin, bone, and heart valves. These tissues are often used to repair or replace damaged tissues in patients.<br />
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== Production ==<br />
The production of biologics is complex and involves several steps:<br />
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# '''Cell Line Development:''' The first step involves creating a cell line that can produce the desired biologic product. This often involves genetic engineering of cells to express the target protein.<br />
# '''Cultivation:''' The cells are then cultivated in bioreactors under controlled conditions to produce the biologic product.<br />
# '''Purification:''' The product is extracted and purified to remove any contaminants or impurities.<br />
# '''Formulation:''' The purified product is formulated into a final product that can be administered to patients.<br />
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== Regulation ==<br />
Biologics are regulated by health authorities such as the [[Food and Drug Administration]] (FDA) in the United States and the [[European Medicines Agency]] (EMA) in Europe. These agencies ensure that biologics are safe, effective, and of high quality before they can be marketed.<br />
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== Challenges ==<br />
The development and production of biologics pose several challenges:<br />
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* '''Complexity:''' Biologics are more complex than small molecule drugs, making them more difficult to characterize and manufacture.<br />
* '''Cost:''' The production of biologics is often more expensive due to the complexity of the processes involved.<br />
* '''Stability:''' Biologics are often less stable than small molecule drugs and may require special storage conditions.<br />
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== Future Directions ==<br />
The field of biologics is rapidly evolving with advancements in [[biotechnology]] and [[genomics]]. New technologies such as [[CRISPR]] and [[synthetic biology]] are paving the way for the development of novel biologic therapies.<br />
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== See Also ==<br />
* [[Monoclonal antibody]]<br />
* [[Biopharmaceutical]]<br />
* [[Biosimilar]]<br />
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== References ==<br />
* {{cite book |last=Walsh |first=Gary |title=Biopharmaceuticals: Biochemistry and Biotechnology |year=2013 |publisher=John Wiley & Sons |isbn=978-1118687383}}<br />
* {{cite journal |last=Rader |first=RA |title=Biopharmaceuticals in the U.S. and European Markets: 20 Years of Development |journal=Nature Biotechnology |year=2008 |volume=26 |issue=8 |pages=855-860 |doi=10.1038/nbt0808-855}}<br />
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[[Category:Biotechnology]]<br />
[[Category:Pharmacology]]<br />
[[Category:Biopharmaceuticals]]</div>Prab