What are Biologics?
Biologics, also known as biological medicines or biopharmaceuticals, are medicines made from living organisms or contain components of living organisms. They are often large, complex molecules and are very different from most other drugs. Biologics are usually proteins but can also include genes, tissues, cells or vaccines. Most biologics are made from human, animal or microbial cells. Some key examples include vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins.
Manufacturing Biologics
The manufacturing process for biologics is far more complex compared to small molecule drugs. Biologics production involves living cells and organisms which means there are higher risks of contamination and process variations. Production takes place in controlled bioreactors where the living cells are cultured in nutrient media and stimulated to express the target therapeutic protein. The cells multiply and express the desired biologic. Quality control checks are conducted throughout to ensure batch consistency. Purification and formulation steps separate the therapeutic protein from other cell components. This careful manufacturing process delivers biologics of consistent high quality.
Mechanism of Action
Biologics act differently than traditional small molecule drugs as they are often much larger and more complex molecules. Their mechanisms involve highly specific interactions with molecular and/or cellular targets in the body. For example, monoclonal antibody biologics bind to specific receptors or proteins on cells to block their action. Other biologics such as vaccines activate the immune system to produce its own protective response. Some gene therapy products deliver functioning gene copies to compensate for faulty genes. This targeted, tailored mechanism allows biologics to treat conditions where traditional drugs could not achieve the desired clinical effects.
Development and Approval Process
Developing a new biologic is a long, complex and costly process often taking over a decade from initial discovery to market approval. Preclinical research involves identifying the molecular target and developing techniques to produce the biologic. Clinical trials proceed through Phases I-III to test safety, dose finding and efficacy in humans. Manufacturing the biologic involves extensive development of large scale production processes under cGMP regulation. Rigorous quality testing proves consistency between trial and commercial batches. The approval process with regulatory agencies like FDA involves detailed review of all clinical and production data. Only after meeting all requirements will a biologic receive marketing authorisation and be made available to patients.
Safety Monitoring Considerations
Due to their complex nature and novelty compared to traditional drugs, special safety monitoring measures are required for biologics after market approval. Many biologics aim to modulate the immune system so their effects may change over time unlike small molecule drugs which get cleared from the body. Pharmacovigilance studies collect long term safety reports on a large population scale. Traceability of batches through unique product codes allows investigation of any quality issues. Risk management plans implement risk minimisation actions like patient registries, restricted distribution programs or educational materials. Serious adverse events mandate expedited reporting. Together, these vigilance measures effectively balance a biologic's benefit-risk profile.
Applications in Disease Treatment
Biologics have revolutionised treatment in many disease areas by targeting conditions where conventional drugs had limitations. Immunology biologics called monoclonal antibodies are used widely for autoimmune diseases like rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis. Hematology biologics boost or modify the immune system to treat cancers like leukemia. Dermatology biologics tackle skin conditions such as psoriasis. Metabolic biologics including recombinant hormones replace deficiencies in areas like growth, thyroid and diabetes. Breakthrough vaccines have nearly eradicated infectious scourges. Gene therapy holds promise for genetic disorders where a missing protein causes disease. Regenerative medicine uses processed human cells and tissues to repair damage from conditions as diverse as heart disease to cartilage and vision loss. Specialised biologics for orphan diseases also provide hope for patients who previously had none.
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