Research and Development: where IBSA Farmaceutici products originate from07 June 2023
What is the process leading to the creation of new products at IBSA? From the first intuition to actual production, there are several teams involved and different steps to be followed, and the Research and Development (R&D) department plays a critical role within this process.
Under the guidance of Andrea Giori, Head of R&D, the first step taken by the department is always the same: listening to the patients, discovering their needs and – starting from their unmet needs – finding inspiration and motivation for the creation of new drugs, supplements, devices and cosmetics; in other words, finding innovative and effective solutions in the “best form”, which for IBSA means formulations and dosing systems capable of simplifying and improving the life of those who use them every day.
In the two plants of Lodi and Cassina de’ Pecchi, the teams dedicated to technological research deal with the initial phase, the one that transforms a “simple” idea into a formula. This is followed by the phase of preclinical and clinical studies, for the pre- and post-manufacturing evaluation of the product itself.
“Our work is not a relay race; the development of a new product is a team effort where a lot of knowledge and multiple skills come together”, explained Giori. “It’s a challenge in which all roles synergistically cooperate to achieve an objective for a period of time that can vary from 1 to 5 years, depending on how long it takes for a product to reach the market”.
At the Cassina de’ Pecchi and the Lodi labs, once an idea has been had and approved, the development phase begins of the formula and the analytical methods, up to the production of the first pilot batches, essential for identifying and understanding any critical issues in the production process. Subsequently, the stability of the product is tested, and the quality and compliance of the ingredients are certified. If all the preliminary requisites are met, the final phase is initiated, with the production of the validation batches and the preparation of the dossiers to be submitted to the competent authorities.
In Ariano Irpino, instead, preclinical studies are carried out, with case analyses taking place in a research centre with one of the largest animal breeding departments in Europe. Through in vitro and in vivo tests, the team ensures the efficacy and safety of IBSA products. Finally, clinical trials are carried out in order to draw up a study protocol and then – with the support of external clinical centres – the observation of the effects on patients is carried out.
Peculiarly, IBSA’s R&D department shares its spaces with production: this closeness is a strategic choice, decided by the company to promote synergy between the two Functions. Placing R&D and production line under one roof, in fact, means allowing a profound mutual understanding between the two divisions, which facilities the entire process: the R&D division proposes and implements projects for which it concretely knows the likelihood of realisation on an industrial scale, exploiting IBSA’s current technologies and evaluating possible innovations starting from the existing lines.