Jacek Ropenga

The mission

« One of our Customers was the holder of an innovative product for which it had obtained an NDA (New Drug Application) in the United States. We were already making the active ingredient for this Customer who was very satisfied with the quality. The Customer asked us to increase the API's level of solubility. »

« To do this, we selected one of the two polymorphic forms this active ingredient could be in and monitored the particle size distribution of the powder. The form sought by our Customer was particularly difficult to obtain! These changes allowed our Customer to patent our innovation. It also involved a new authorization request from US health authorities to validate the changes and the new synthetic route. Seratec's laboratory is inspected by the FDA, so we were able to meet the regulatory requirements. »

Jacek Ropenga, Technical director

Jérôme Sausset

The challenge

« To produce the API with the particle size specified by the Customer while retaining its crystalline form, we had to change our process as well as the associated control methods. We were in continuous development! »

« Indeed, the first clinical tests confirmed that the new particle size was more advantageous, but they also proved that a different synthetic route was necessary. So, we had to start from scratch and rework the crucial stage of crystallization in particular. It was a real challenge, especially since the form we were seeking was not the most stable; we had to find a way to guide the formation of the molecule. This entire process took place with our Customer's quality approval and our Customer was present at all times and controlled every step. »

Jérôme Sausset, Chemistry Technician

Patricia Bataille Leconte

The key

« Crystallization is a complex step involving many parameters. We looked at everything: the heating and cooling temperature, the agitation speed, the solvent proportions …Then we researched what criteria could intervene on the criteria that we wanted to achieve. »

« Our experiment was very helpful: we knew where to focus our research, but we still had to perform a lot of tests. We adopted a very structured approach and proceeded step by step: the outcome of each experiment level guided us for the next one, until we were able to find ideal conditions. We also had to invest in new equipment: our reactors were completely modified to include an in-line technology that detected in real time, the formation of crystals in the solution. After 3 months of work, we were finally able to determine the parameters of the real-time release tests (RTRTs) that we were looking for. Then we had to validate the process, that is to say, prove that it could be duplicated to reproduce the active ingredient on demand. »

Patricia Bataille Leconte, Head of Operations

Maria Moreno Guirado

The key to success

« Our Customer's requirements were extreme, in terms of quality and safety, but we were able to honor them by improving our process. The active ingredient was produced according to the required criteria, and our Customer was able to get the NDA required to distribute its drug in the United States. This mission drove us to go further! »

« We have all the required skills in-house, a team passionate about improving approaches and we control our processes from A to Z. This enables us to be very agile and respond quickly when our methods or our equipment needs to be changed. We can significantly shorten the response times for this type of request. To always aim higher and be more efficient is central to our corporate culture! »

Maria Moreno Guirado, Quality & GMP Compliance Department