Macromolecular drugs (macromolecules), also known as biologics, are medicines used for the prevention, treatment and diagnosis of human diseases, which are prepared by applying common or biological materials such as microorganisms, cells, tissues and fluids of various animal and human origins obtained by biotechnologies such as genetic engineering, cellular engineering, protein engineering, fermentation engineering, etc. Macromolecular drugs have large molecular masses (MW), hydrophilicity, variable solubility, limited chemical stability and gastrointestinal degradation.Macromolecular drugs have the characteristics of large molecular mass (MW), hydrophilicity, variable solubility, limited chemical stability and gastrointestinal degradation.At present, the development direction of new macromolecular drugs mainly includes monoclonal antibody, gene therapy, cell therapy and so on.With the rapid development of biotechnology, biomolecule drugs have been widely used in the treatment of tumours, autoimmune diseases and metabolic diseases (e.g. various cancers, chronic diseases, multiple sclerosis and cystic fibrosis).
Firstly, in terms of therapeutic mechanism, compared with chemical small molecule drugs, biologic large molecule drugs mainly play their role by stimulating the body's immune system to produce immune substances (e.g., antibodies), resulting in humoral immunity, cellular immunity, or cell-mediated immunity in the human body.
Secondly, while small molecule drugs are usually administered orally, biopharmaceuticals are usually administered intravenously or by subcutaneous injection.Compared to small molecule drugs, most large molecule drugs tend to have slower absorption, limited distribution, and different metabolism and elimination mechanisms.Due to their longer half-life, they remain active for a longer period of time, have better patient compliance, good reproducibility and less individual variation.
Furthermore, macromolecular drugs are made from microorganisms, cells, tissues and body fluids of animal or human origin by applying traditional technology or modern biotechnology, which are easy to be inactivated and require higher preservation conditions.On the other hand, most of the small molecule drugs are chemical drugs, except for some specific drugs, the other requirements for preservation conditions are relatively loose.
Updated: Jan 01, 2025
