How are Biologics and Biosimilars medicines developed?
Biologics and Biosimilars are made in living organisms to produce proteins to treat various diseases by genetically modifying cell constructs or cell lines.DNA technology is used to insert desirable genes or remove undesirable ones within a living cell or via a vector such as a virus.This prompts a specific function such as the production of a protein to treat diseases.
Biotechnology has led to the development of many of todays most important medicines including monoclonal antibodies for the treatment of cancer and human insulin for the treatment of diabetes. The genetic code of a chosen protein (Insulin) is identified and replicated but combining different segments of DNA to build a functional DNA sequence. The DNA sequence is introduced into the host cell of a living organism such as bacteria, yeasts or mammal cells altering the genetic makeup and coding to produce the chosen protein.
Genetically modified cell lines are carefully selected and cultured in large bioreactors. The bio-logic or bio -similar medicine is extracted through complex purification processes. Each step is intricate, sensitive and specific to a particular medicine. Minor alterations may lead to changes in cell behavior, structure,stability or other quality aspects of the end product. Any of these differences have the potential to affect the treatments safety, efficiency or shelf life which will increase the risk of an unwanted immune response.