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Biodrugs, a world of possibilities

Biodrugs, also known as biological medicines, and their active ingredients are produced from biological systems. These biotechnologies use living resources and gene modification (cell lines, DNA, clones, etc.) to produce macromolecules (proteins, antibodies, cells, vectors, etc.) that can deliver new innovative treatments in many fields (oncology, neurology, immunology, virology, etc.).

Did you know?

Biodrugs are generally better tolerated by patients than conventional chemical therapies. They also improve diagnoses and treatment response predictions.

The biodrugs developed through bioproduction include, among others, vaccines, recombinant proteins (for example, insulin obtained from biotechnologies), monoclonal antibodies and new generation antibodies (bispecific, functionalized) or advanced therapy medicinal products (gene and cell therapy, tissue reconstruction).

This new generation of treatments represents a major therapeutic innovation and a crucial step toward precision medicine.

1 out of 2

Half of the medicines used worldwide to treat cancer are derived from bioproduction. Biological medicines use is expected to increase over the next few years.1

Produced exclusively from living cells (or extracts), the active ingredients in biodrugs have a complex structure. Their size can be a thousand times bigger that of a standard active ingredient, which is small and has a simple structure.

Four main steps are necessary to obtain sterile macromolecules that comply with the quality criteria required. These steps allow reproducible and reliable therapeutic results to be obtained for patients. For example, these are the steps for producing a recombinant protein like a monoclonal antibody.

1/ Cell culture

Stored at very low temperature, the cells that produce therapeutic molecules (such as recombinant proteins or antibodies) are thawed before being cultured in nutrient media.

When they are sufficient in number, the cells are transferred into larger bioreactors to manufacture the active ingredient (antibody, protein, vector, etc.) of the future medicine at a larger scale.

2/ Filtration and extraction

Cells are separated from their culture medium through filtration or centrifugation. The filtrate (resulting from filtration) or the supernatant (resulting from centrifugation) is then isolated for purification.

3/ Purification

Impurities and contaminants (cell debris, culture medium components, etc.) are eliminated from the macromolecule over the course of several purification steps. The concentration of the active ingredient then adjusted, using a formulation buffer that stabilizes it, to optimize molecule quality.

The drug substance obtained is packed in bags or bottles, then refrigerated or frozen while awaiting the last aseptic distribution step (fill and finish).

4/ Standardized pharmaceutical form

The biodrug is distributed aseptically in syringes or vials. It must still undergo a number of quality tests as well as obtain authorization from health authorities before being placed on the market.

Biological medicines currently represent almost 30% of the global pharmaceutical market. And this is only the beginning! Four out of every 10 new medicines released on the market are derived from biotechnologies2. Biotechnologies are constantly evolving, paving the way to increasingly broader therapeutic options.

Thirty years ago, the term biotherapy was synonymous of recombinant proteins and antibodies. It can now refer to an antibody derivative (bispecific, conjugated antibodies), a messenger RNA, a viral vector (gene therapy), or the set of cell therapy approaches such as CAR-T — thanks to progress made in gene and cell therapies.

The recent integration of artificial intelligence and automation​ will allow the efficacy, quality and speed of development and bioproduction of medicines to be improved.

About Servier ?

A key player committed to the biomanufacturing sector, for several years Servier has developed anti-cancer products of biological origin.

Since 2020, we have developed our biological medical product candidate pipeline thanks to the acquisition of Symphogen, a technological platform in Denmark that develops new generation antibodies.

Today, biological medical products represent 50% of our R&D project pipeline in the fields of oncology and auto-immune diseases. This development in our activity has led to us to invest further into our Gidy production site located in the Loiret region of France. There, we have built Bio-S, our first production unit for active ingredients derived from living cells to be used in our clinical trials. This unit is expected to begin producing its first clinical batches mid-2025, once authorization has been granted by the ANSM, the French National Agency for Medicines and Health Products Safety.

[1] MyScenari – les médicaments biosimilaires (
[2] France Biolead