Different from totally synthesized pharmaceuticals, they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general project on biotechnology for class 12 pdf category.
Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
In some jurisdictions, biologics are regulated via different pathways than other small molecule drugs and medical devices. The term biopharmacology is sometimes used to describe the branch of pharmacology that studies biopharmaceuticals. Blood plasma is a type of biopharmaceutical directly extracted from living systems. Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially.
Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA. As indicated the term “biologics” can be used to refer to a wide range of biological products in medicine.