What They Are
Biologics are medicines produced from living organisms using commercial biotechnology techniques. They are far more complex than “traditional” small-molecule, chemically-synthesized molecules. For example, even a simple biologic such as calcitonin has a molecular weight of nearly 3500 daltons compared to just 180 daltons for aspirin – while a complex monoclonal antibody clocks in at 150 000 daltons. Biologics therefore represent a distinct regulatory class of medicine.
Many biologics are recombinant proteins, which can be produced at commercial scale in a number of ways including “recombinant DNA” (inserting a specific gene into a host cell to produce a particular protein) or mammalian cell culture technologies. These methods are highly sophisticated and resource-intensive, requiring dedicated production lines and specialist training; quality standards are also exceptionally high.
Developing and manufacturing a biologic typically involves a four-stage process:
- Modify host cells (e.g., bacteria, yeast) to produce recombinant proteins
- Grow the cells under controlled conditions (fermentation)
- Extract, refold, and purify (downstream) to generate the drug substance
- Formulate to create a stable finished drug product (vial, syringe, cartridge)
