Antoine Réveilleau

The mission

« We were contacted by a French laboratory that had just acquired the authorization license to market a drug with a large pharmaceutical company. Their problem was that they were unable to find a trusted producer for the active ingredient of the drug, and inventories dwindled… They were on the verge of a supply disruption. »

« That was a big challenge for us, because the traditional manufacturer of the active ingredient only provided a brief description. We explored different routes, the mission being all the more complex since it concerned a HAPI, a highly active substance particularly difficult to handle. Everything had to be reinvented ! We love this kind of challenge, which stimulates our creativity and allows us to build skills. »

Antoine Réveilleau, Chairman

Sarah Couturier Alanvert

The challenge

« This mission was a real challenge on several levels. We had to develop a new synthesis route in a very short timeframe, while producing the required regulatory documentation which was extremely demanding for this type of project. »

« We absolutely had to find an original method which would enable us to achieve a significant level of quality that met the requirements of our Customer, the authorities and Seratec. Concurrently we managed the specificities inherent in the handling of a highly active ingredient: the production process had a high level of risk for both the facility and for the operators. Lastly, there were vital issues for the patients and so we really had to act quickly. The human aspect was very motivating. »

Sarah Couturier Alanvert, Head of R&D

Sonia Gebczynski

The key

« We got our Customer's consent to develop a new synthetic route, but we also had to get the authorities' consent in a very short period. Fortunately, everyone was aware of the emergency and we all really wanted to move quickly! »

« The Medicines Agency granted the Marketing Authorization (MA) exceptionally fast with one important condition: our product was required to have a similar or superior quality to the one on the market (particularly impurities). We still needed to develop a new manufacturing process that met these requirements. We carried out numerous experiments and succeeded in developing a satisfactory new synthesis route. In parallel, we conducted the risk analysis and considered various scenarios of failures, to determine their causes and assess their consequences. Following this analysis, we established new protection procedures that were more strict than usual, to reduce the risks to an acceptable level. It was necessary to adapt and make significant investments to achieve our goals. »

Sonia Gebczynski, Director of the Quality Control Laboratory

Patricia Bataille Leconte

The key to success

« In 3 months, we were able to deliver a HAPI and make the first batch available to our Customer, who was then able to produce the drug on time. The supply disruption was avoided: Mission accomplished! »

« For this project, the key to success was our structured approach. We worked methodically, and we adjusted our actions to our resources. Our teams' considerable expertise and the constant demand for quality we are subjected to, have enabled us to meet this kind of challenge. We were also able to count on constant personal commitments from the whole team. In the end, the Customer was very satisfied; this is the most important success in our view. Today, we are still manufacturing this API, and we are in a process of continuous improvement. We are always in search of higher quality, and our management strategy is enhanced and refined after each batch. Our constant quest for excellence drives us to do our best every single day! »

Patricia Bataille Leconte, Head of Operations