What are Biopharmaceuticals?
The term “biopharmaceuticals” refers to drugs that have unique qualities in the way that they are derived and manufactured as opposed to traditional drug products. Biopharmaceuticals are protein-based and may either be derived from genetically altered bacteria or fungi (also called biotech drugs), or may come from blood and blood plasma products (usually referred to as biologics). Because of their unique status, biopharmaceuticals have not generally been able to be produced generically even though a number of these products may have patents that have expired. The official name for generics of these products (per the FDA) is “follow-on biologics”; however, they have commonly come to be called biogenerics. Some common examples of biopharmaceuticals include Enbrel, Aranesp, Epogen, Neupogen, Gaminex, recombinant human insulin, and human growth hormone, to name but a few.
Biopharmaceuticals are defined as pharmaceuticals manufactured by biotechnology methods, with the products having biological sources, usually involving live organisms or their active components. The methods and techniques that involve the use of living organisms (such as cells, bacteria, yeast and others) as tools to to perform specific industrial or manufacturing processes are called Biotechnology. Biotechnology is delivering significant advances in human healthcare. Entirely new medicines are being created, notably for rare or previously untreated diseases. Biotech production methods provide safer versions of existing treatments in unlimited quantities. Biotechnology has revolutionised the research and development of new medicines and allows better product targeting for specific diseases and patient groups. A greater understanding of the genetic causes of disease allows early detection and treatment, and the new field of gene therapy may even herald the possibility to cure diseases,
Biopharmaceuticals are drugs which are produced with the means of biotechnology. There are a number of ways in which such drugs can be made, but the key distinction between them and other drugs is that they are not extracted from a native source or synthesized with chemical reactions. Instead, they are created with the use of living organisms which may have been modified to produce the desired compound. This requires the use of specialized equipment and clean rooms for safety which protect the integrity of the pharmaceutical compounds while they are produced and packaged. One classic method of making biopharmaceuticals involves the use of a bioreactor, a container which is used to create tightly controlled conditions which facilitate the growth of a particular organism. In a bioreactor, drugs can be produced by organisms which generate biopharmaceuticals as a byproduct of their life cyle, often because these organisms have been modified to produce specific proteins and nucleic acids. C
