(AFP) – Therapeutic antibodies are the medicine of the future, but they have yet to be manufactured in Europe, says Jacques Volckmann, head of research and development for France at the French laboratory Sanofi.
Sanofi, like many other labs, has therapeutic antibodies on the market or in development among its treatments. Why is?
To understand the origin of antibodies, we need to look at how our bodies work. The immune system has specialized cells that produce these large molecules: our antibodies, which are proteins. It is one of the body’s defenses against attacks, such as bacterial or viral. The body sends out these little +missiles+ that block and prevent the spread of a virus, for example.
We have been able to produce specific antibodies in the laboratory for around thirty years. We take the DNA of the antibody you want and clone it into a mammalian cell that will produce it. Improvements in molecular biology technologies have accompanied the development of these techniques. There are many applications in immunotherapy, oncology and infectiology.
In recent years we can also produce multispecific antibodies: they can bind simultaneously to several antigens involved in the disease we want to fight.
Not to mention the so-called “ADC” antibodies (Antibody Drug Conjugates), the “armed” antibodies. In this case, we design an antibody that recognizes a specific antigen on a tumor cell, we attach an anti-cancer molecule to it, and the antibody just takes it to where the tumor is. The possible uses are immense.
Therapeutic antibodies are expensive, how does that explain this?
The production of a protein is complex. We start from a DNA sequence, i.e. the genetic code of the protein of the antibody. This sequence is integrated into a mammalian cell, cultivated and the multiplied cells then produce the antibody. Then this antibody is purified, resulting in the active raw material.
These are long, expensive and complicated procedures using very special and expensive equipment and expensive culture media. All this for relatively low returns. The first productions had a yield of the order of 0.1 grams of antibody per liter of culture. Now the yield is about 1 g, even 10 g per liter. With the same factory we produce 100 times more than before. There will inevitably be improvements in earnings over the next ten years.
A very small part of the antibodies used in France are manufactured in France. Is this an important issue?
In our R&D portfolio, 70% of projects are biological molecules, including a significant proportion of antibodies. Not just at Sanofi. We have evolved from a portfolio of chemically manufactured drugs to biological molecules in just a few years.
They need to be produced and therefore have the production capacity. This is a big challenge for France. Many of the future medicines will be biologics, but our network of biomanufacturing facilities is less developed than in other countries. If we cannot produce these bio-medicines, at least at European level, it will be more complicated to access them, especially in the event of a crisis.