Antibodies play an important role in our immune systems, defending our bodies from invaders like viruses. By making antibody medicines, we can help fight a variety of diseases. Read on to find out more about the complex processes involved.
Antibodies attach to invaders from outside the body as part of our natural defence to certain illnesses. Today, antibody medicines are made to copy this process to help fight diseases including cancer, rheumatoid arthritis and viruses.
Antibodies are very large, complex proteins made of around 25,000 atoms, whereas medicines like common painkillers may only have around 20 atoms.
In our bodies, antibodies are made by a type of white blood cell, which protects the body against foreign invaders. When manufacturing antibody medicines they are also made in living cells.
Making antibody medicines is a very complex process. In order to create a new antibody it takes around 12 months from the first step, when a genetic code is given to cells as an instruction manual to produce the antibody, through to the medicine being ready to distribute to patients. The manufacturing process for using an existing antibody takes about 3-4 months, from thawing a vial from an existing cell bank until the final medicine is ready.
Manufacturing antibodies inside living cells is an intricate, multi-step process. It involves constant testing to ensure it is done safely, accurately, and in a completely clean environment.
The term ‘monoclonal’ antibody means an antibody made from identical living cells (mono = single; clonal = clone). These identical cells produce identical antibodies, which is crucial when making a medicine.
To make enough antibody medicine for patients in need, the cells that are used to grow the antibody are multiplied in production tanks containing trillions of cells.
Antibody production tanks contain ‘food’ for the cells growing in them. This food is carefully prepared from as many as 100 different materials.
Once the antibodies have formed correctly, they are separated from the fluid they grew in and other unwanted substances. Then they are packaged and safety tested again. Only then can the medicine be ready.
30 years ago, it was only possible to produce a few grams of antibodies in one year. Today we can produce over 10 tonnes. We are always striving to improve processes to help deliver medicines to people who need them quickly, but maintaining the highest standards of quality and safety must remain our priority.