Recherche et Developpement - Les Laboratoires TEOXANE

TEOXANE / RESEARCH AND DEVELOPMENT

Research and Development

Our state-of-the art manufacturing unit complies with the strictest standards. The Research and Development department incorporates a manufacturing unit.

The R&D department is made up of a multi-disciplinary team of top-level scientists who work on the development and continuous improvement of our products. Permanent medical and clinical watch and regular contact with the whole of the medical profession enable the R&D team to develop innovations in line with doctors' expectations and anticipating future needs.

The Teosyal® range is wholly developed and manufactured in-house. Continuous interaction between the R&D and production departments creates an outstanding dynamic and optimum flexibility.
Internal and bibliographical research enables the R&D department to devise new formulas. To be selected, a formula must provide every possible guarantee in terms of safety and effectiveness. Only then can full-scale production be considered.

Teoxane's key assets are its skill and expertise.
In just three years, the quality of Teoxane's products has propelled it to third place worldwide among hyaluronic acid manufacturers.

Manufacturing facility

The manufacturing facility was designed and built in Geneva in 2003, in compliance with the recommendations of the EMEA (European Medicines Agency) and the FDA (Food and Drug Administration). This unit has specially designed clean rooms with state-of-the-art equipment.
The manufacturing process is carried out and validated in compliance with international ISO 9001 and ISO 13485 standards and European Council Directive 93/42 concerning medical devices.

MANUFACTURING STAGES:

Cross-linking:
To optimise their lifespan in the skin, Teosyal® gels are cross-linked. This involves linking macromolecules of hyaluronic acid together with "bridges" which makes them more resistant to being broken down, particularly by hydroxyl radicals. The cross-linking agent used in Teosyal® is BDDE.
After cross-linking, the hyaluronic acid molecules form a dense, interlocking mesh.

Purifying:
In order to remove any BDDE residue which may not have reacted during cross-linking, the gel is purified.
Primary packaging:
The gel is then packaged in 1ml glass syringes. This stage is fully automated.

Sterilisation:
Because hyaluronic acid is sensitive to heat, traditional sterilisation cycles damage the gel, which becomes less viscous and less effective.
This is why Laboratoires Teoxane has developed a dedicated sterilisation cycle for Teosyal® gels so that the products retain as much of their visco-elastic properties as possible.

Final inspection and secondary packaging:
Each syringe is individually inspected by specially trained operators.
The syringes are then labelled and blister packaged. Instructions for use and traceability labels are then added and slipped into a cardboard package.
All these processes are fully automated.

Testing:
A large number of tests are carried out on each batch of Teosyal® range products, in compliance with EU standards EN 1174-1 and EN 1174-2 and with the European Pharmacopeia in force (sterility test, bacterial endotoxin test, pH values, etc.) The Quality department, acting independently of the production department, analyses the results of these tests and authorises the release of compliant batches.

Total control of these processes enables us to provide products which are both safe and long-lasting.