2. Production Process

Biologic medicines are produced using living cells in which many copies of the required proteins are made. Proteins are produced from pieces (known as sequences) of the genetic material deoxyribonucleic acid (DNA), which is found in cells. A sequence of DNA is identified that produces the chosen protein, or parts of the protein, that will be used to diagnose, treat or prevent a particular disease. This protein made from the DNA sequence will form the active component of the biologic medicine. The DNA sequence is inserted into a carrier known as a vector, which then transfers the DNA sequence into a living cell. Each cell that receives the DNA vector will produce a copy of the missing or non-functional protein, and these cells are grown in containers under conditions that allow them to grow in number and produce large quantities of the protein. The proteins are then extracted from the cells, purified and tested for quality. Subsequently, the purified protein is converted into a formulation (e.g. powder or liquid) that can be used as a medicine.