Sarah Couturier Alanvert

The mission

« We are recognized specialists as a manufacturer of intricate, active ingredients in small volumes. A new Customer entrusted Seratec to manufacture a complex API for a generic drug they intend to launch in the US market. Speed is particularly important to our Customer and Seratec knows how to respond. »

« Indeed, when a new generic is placed on the market in the United States, the first entry has exclusivity for 6 months and will always remain the main market player. It is therefore essential to proceed rapidly and be comprehensive with the first filing. »

Sarah Couturier Alanvert, Head of R&D

Frédéric Marin

The challenge

« We started our work with the monograph provided by our Customer, which specified the molecule to be manufactured. Seratec's quality standards are set at a higher level than required and Seratec strives for the best from the start of the project. »

« So we had to quickly develop a synthetic route of the active ingredient and control methods that would allow us to meet our standards of excellence and an acceptable level of productivity. Throughout this research phase, we were in constant discussion with our Customer, who was progressing with the development of the drug. »

Frédéric Marin, Business development manager

Patricia Picoux

The key

« The search for a synthetic route for the production of an active ingredient is an extremely painstaking process. First stage: define the most relevant synthetic route. For this, we use all our resources (knowledge, analyses, bibliographies…) and we conduct tests step by step until we have successfully isolated the product. »

« Then comes the second stage, which is the most important: rework our processes over and over again to refine our parameters and thus improve quality, until we have reached the high standards imposed by regulations and by our own requirements. The choice of suppliers for the materials we use is also a decisive factor: everyone has their method of production and different characteristics that we have to qualify. To advance towards excellence, no parameters can be neglected! »

Patricia Picoux, Scale-up Manager

Julie Sébillot

The key to success

« This project is still ongoing and many months are needed to produce such a complex molecule. The Customer is pleased and in good position to win this race! »

« Our greatest strength in this area is our responsiveness: we have all the skills in-house, we can adapt very quickly and we question ourselves after each test to advance a little more toward an optimal mode of production of the API. We go the extra mile every day and we hope to be the first to achieve success for our Customer. »

Julie Sébillot, Quality Technician