Cell-Free fields of application
Biomedicines or biological drugs include therapeutic molecules and macromolecules produced by living organisms, as opposed to those produced by chemical synthesis. The active substance is produced or extracted from a biological source.
Biomedicines have existed since ancient times, when organ extracts were administered for therapeutic purposes (blood plasma to treat haemorrhages, spinal cord extract to treat CNS diseases, etc.). The first biomedicine developed on an industrial scale was insulin. Initially extracted from the pancreas of cattle or pigs, it has been produced recombinantly from bacteria since the 1980s. Today, biomedicines include a wide variety of products (see Figure 1).
Diversity of biomedicines
DNA or RNA vaccines
Proteins account for the majority of biomedicines on the market, including subunit vaccines, therapeutic antibodies, enzymes, protein hormones, growth factors etc. But the list also includes sugar polymers such as heparin, and nucleic acids such as RNA or DNA vaccines and gene therapies. Finally, biomedicines are used in many fields: infectiology, oncology, rheumatology etc. (see figure 2). They represent a growing proportion of drugs on the market.
Classification by therapeutic area of the 168 biomedicines marketed in France (as of May 31, 2013)
- Nephrology 1% 1%
- Ophthalmology 1% 1%
- Gynecology 2% 2%
- Cardiology 2% 2%
- Transplantation 2% 2%
- Pneumology 2% 2%
- Cardiology 2% 2%
- Dermatology 3% 3%
- Neurology 3% 3%
- Gastroenterology/Hepatology 4% 4%
- Hemostasis 5% 5%
- Metabolism 5% 5%
- Endocrinology 6% 6%
- Diabetology 6% 6%
- Rheumatology 6% 6%
- Oncology/Hematology 18% 18%
- Infectiology 32% 32%
The development of biomedicines includes a number of stages starting with the identification of therapeutic targets, in which the screening and selection of biomedicinal leads occur.
These leads are then optimized together with their production system. The selected biomedicines are then subjected to preclinical and clinical evaluation before being approved for marketing.
The stages in the development of biomedicines
1/ Target discovery
2/ Molecule screening
High throughput screening.
Selection of high potential molecules.
3/ Optimization of the selected molecules
4/ Evaluation of candidates (pre-clinical)
5/ Clinical trials
6/ Review and approval
SYNTHELIS is proud to participate in a state-sponsored biomedical research program, the “Grand defi” (the Great Challenge) which aims to improve the yields and reduce production costs associated with biomedicine production.
The “iCFree” program, carried out in collaboration with the MICALIS, CARMEN and I2BC Institutes, aims to develop cell-free protein production systems. These cell-free systems are optimized by “machine-learning” methods for the production of therapeutic products that are difficult to obtain in vivo, such as antimicrobial proteins.
Cell‑Free Protein Synthesis: A Promising Option for Future Drug Development
Research project designed for Sanofi Pasteur (pdf)
Solubilisation of a strongly aggregated vaccine antigen
Government - France (pdf)
"New expression systems" of the great biomedical challenge
Leem - Biotech Committee (pdf)
Biomedicines in France: state of play