From Pre-clinical phase to Commercial
For clinical and toxicological studies
We are proposing our centers in Saint Julien en Genevois for all biotech molecules to be produced as a Bulk Drug Substance. Your molecule produced by Cell culture or fermentation or either by plant cell culture (using our Gaillac Chemical expertise center) can be produced in one of our development center.
In addition, we can propose you all our expertise in purification of such molecule for improvement, characterization and industrialization of your developed process.
For additional activities like Analytical Development and Formulation development of your specialty. We provide a full service with our resources located either in Saint Julien en Genevois for all type of large molecules or from our highly skilled development center in Toulouse for small and special molecules.
In addition, we can insure the fill and finish activities for you in our pilot scale manufacturing workshop, fully equipped to support all of your specialties including : High potent products (Antibody Drug Conjugates, bi-specific antibodies, monoclonal antibodies, hormones….), conventional products are part of our supply and particularly any custom made processes like sustain release products and specific processes including no water content products, non metallic contact processes and usage of Highly explosive organic solvents….
All these activities are handled by one Project Leader who will be appointed by CDMO Department and dedicated to your project, he will be in charge of coordination and monitoring of the project from your clinical phase until your commercial transfer in one of our industrial scale manufacturing site. This will be able to insure your company a better management of the project and a transversal overview of the successful development and transfer to industrial supply at discounted price. No transfers, No additional costs, one audit, one partner, one success.
Global Quality compliance
All activities proposed in our premises are fully compliant with worldwide regulatory environments.
We have been audited since more than 25 years by worldwide authorities like FDA, EMEA and PMDA for more than 20 years.
Any other agency will be welcome for the success of your project in clinical or in commercial phase.
Actually fully compliant with more than 100 countries worldwide regulations, we have products manufactured and sold in USA, Europe, Japan, Brazil, Korea, Middle East countries, South American countries, Australia, Africa.