What are biologics?

“large complex molecules produced in a living system”

A biologic is a product that is produced from a living organism such as bacteria, yeast or plant or animal cells. Often the products produced are large, complex molecules or a combination of molecules.  It is extremely common for biologics to be produced using recombinant DNA.  Examples of biologics are monoclonal antibodies, vaccines, gene and cell therapies.  Commercial examples might be Herceptin or Gardasil.   Biologics are often difficult to characterise simply due to their complexity with some of the components in a finished biologic remaining unknown.  It is common for a biologic to have lengthy processes for production that may take weeks to produce, test and release.  To ensure consistency of the biological product, manufacturers tightly control the starting materials and typically use hundreds of process controls to ensure predictable manufacturing outcomes that result in a safe and efficacious product.