A silent revolution is underway. The development of biodrugs allows therapeutic alternatives to chemical molecules to be put forward in a number of treatments, such as those prescribed to fight cancer, chronic diseases, or certain rare diseases. As a key contributor to current and future health challenges, the biomanufacturing sector opens up new avenues to explore, offering hope for many patients.
What are biodrugs?
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.).
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.
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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
Bioproduction: How are biodrugs made?
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.
Bioproduction, a challenge for the future
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.
“These different therapeutic options correspond to very different industrial approaches, and therefore their technology requirements are very demanding. A major challenge for financing biotech innovations is to make choices that take into consideration both the therapeutic potential of each option and the industrial reality that will accompany its production and availability to patients under good quality and cost conditions. With Bio-S, we choose to innovate by focusing on biotherapies that will allow us to develop new medicines within timelines and industrial conditions compatible with patient needs.”
Olivier Russo, Global Head of Chemistry, Manufacturing & Controls
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.