The world of parenteral medicines is going through a phase of profound transformation which involves several key sectors, such as the possibility of conveying genetic material using non-viral nanovectors which allows us to address complex therapeutic challenges. But the world of parenterals is also affected by compliance with the new requirements introduced by the Annex 1 guidelines the implementation of which will also involve lyophilisates.
The XVI session of the 63rd AFI Symposium, entitled “Production of parental and flyophilisates: challenges and solutions in considering Annex 1“, will analyze the challenges linked to these evolutions and discuss possible emerging solutions.
During the session, emerging formulation approaches to satisfy unmet clinical needs will be illustrated with the aim of personalizing therapy on the individual patient.
Furthermore, the interventions will offer an overview about the lyophilization process, underlining the critical aspects that influence the quality of the product, the possible solutions that can be implemented to achieve compliance with the requirements of Annex 1, and the technological innovations in the field of continuous manufacturing.
Francesca Selmin, coordinator of Parenterals Study Group of AFI, gave an interview in which she presents us with the major transformations in the world of parenteral medicines, as well as the most impactful aspects of the innovations introduced by Annex 1, underlining how these guidelines impose a change in the culture of paramental production aimed at increase the quality of medicinal products.
