Biological drugs are medicines produced from living organisms or their derivatives. Unlike traditional drugs, which are synthetic chemical compounds, biologic drugs include active ingredients produced or extracted from a biological system, such as proteins and antibodies.
How are biologic drugs produced?
Biological drugs are produced using advanced technologies that take advantage of living organisms, cells, or biological molecules.
The process begins with the identification and isolation of the biological substance of interest, which can be obtained from cultures of bacterial cells, yeast, animal cells, or genetically modified plant cells. Once obtained, the biological proteins or molecules are purified and formulated into specific dosages suitable for therapeutic use.
The production of biologic drugs requires rigorous quality control and regulatory compliance, as even small variations in the production process can affect the efficacy and safety of the final product.
Types and applications
Biological drugs can be divided into two main types according to the manufacturing process:
- Classical biological drugs: obtained through extractive processes from biological starting materials. These materials may include unmodified prokaryotic or eukaryotic cell cultures, plasma, and natural products derived from plant, animal, and human tissues.
- Biotechnological drugs: are produced by extraction and purification from cell substrates that have been engineered (e.g., by insertion of the gene of interest) or modified (such as cell fusions, continuous cell lines, monoclonal antibodies).
Both types of this drugs have wide and diverse applications in the treatment of a wide range of diseases and medical conditions. Due to their biological nature and ability to target specific targets in the human body, these drugs are particularly effective in treating complex diseases such as autoimmune diseases (e.g., rheumatoid arthritis and lupus), cancer diseases, immune system disorders, and some genetic diseases.
In the field of oncology, for example, biologic drugs are used to target specific antigens on cancer cells, improving treatment efficacy and reducing side effects compared with conventional therapies.
They are also used to stimulate the immune system or restore impaired cellular functions. This precision in action and highly targeted approach make biologic drugs a crucial therapeutic choice for many complex medical conditions that are difficult to treat with conventional drugs.
The biologic drug market
The biologic drug market is experiencing significant and continued growth. With increasing understanding of diseases at the molecular level and advanced genetic engineering technologies, more and more companies are investing in the development of innovative biologic therapies.
The field is moving toward greater personalization of care, with increasing adoption of cell and gene therapies, as well as continued expansion of applications in oncology, immunology, and rare diseases.
As research progresses and regulatory approvals accelerate, the future of biologic drugs looks promising, with predictions of increased availability of innovative treatments that could radically transform the management of chronic and serious diseases.
