Biologic Derived Pharmaceuticals
Biologic Derived Pharmaceuticals or Biologics are the pharma products that are derived or produced from living organisms or have some components of living organisms. The Biologic Derived Pharmaceuticals include a variety of drugs and pharma products that are derived from microorganisms, animal and humans and are derived with the use of advanced biotechnologies. These types of drugs include the vaccines, blood, components of bloods, tissues, genomes and so forth. These drugs may contain proteins that are supposed to control the working and impact of other proteins that are produced in the body. They can also be used for controlling the genetic actions and cellular processes taking place in our body. They are also considered as the biologic response modifiers as they alter the biological manner in which a certain group of cells may act. They can also be used for activating or suppressing the components of the immune system.
Medical Uses of Biologics
The biologics are used for treating a variety of chronic and acute medical conditions which of not respond to conventional medicines and modalities. Some of these conditions include ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, chron is disease and many other autoimmune diseases. The drugs can also be used for treatment of cancer and is the most advance treatment available for that.
Side effects of Biologics
There may be some side effects of the biologic pharma products as they tend to suppress the immune system and hence increase the risk of infections. Also when they are administered through injection, they can cause the injection site reactions. The intravenously given biologics can fusion reaction.
Quality of Biologics
As the biologics that are used for treatment of autoimmune disease are very sensitive and can have severe side effects if not administered properly. One factor that plays an important role in the efficiency of the drugs is their manufacturing quality. The manufacturing facilities where they are manufactured, have to follow the most strict norms related to quality as stated in ISO 17025:2017. And as the quality of the products can be life defining, the regulatory authorities also make sure that the all the quality norms are followed strictly by the manufacturers. In addition to the manufacturing process and facility, it is also essential that each and every biologic drug passes the strict quality tests as no chance can be taken with the quality of these drugs.
The manufacturers must ensure that the drugs are tested under the norms of ISO 17025:2017 in an NABL accredited facility and hence it is advisable that manufacturing facilities have their own testing facility and get it accredited by NABL so that it could be ensured that the lab that is used for quality assurance of the biologics gives the most efficient and accurate testing results and there is no compromise with the quality of the products.
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