Stevanato Group Cette flexibilité signifie que la plateforme Aidaptus® est idéale pour s’adapter à un schéma posologique complexe au sein d’un seul appareil. En conséquence, le temps et les coûts asso- ciés au développement et à l’industrialisa- tion sont considérablement réduits, car la production peut être concentrée sur un seul format d’appareil et une seule référence, évitant ainsi les complications potentielles liées à la gestion de plusieurs configurations d’appareils. Dans le développement de produits médi- camenteux génériques GLP-1, cette adap- tabilité peut être utilisée pour accélérer la mise sur le marché d’une demande abré- gée de nouveau médicament (Abbreviated Stevanato Group est le fabricant à façon et le partenaire commercial exclusif pour Aidaptus® Stevanato Group is the exclusive contract manufacturer and commercial partner for Aidaptus® applications in all their diverse forms. extensive value by the strength of its inte- industrialisation are significantly reduced This includes the development of generic grated offering, which includes high-level because production can be concentrated devices to deliver, for example, gluca- capabilities in drug containment, exten- on one device format and SKU, avoiding gon-like peptide 1 (GLP-1) agonists for ding from the robust supply of high-level the potential complications of managing the treatment of type 2 diabetes and components through to the manufacture multiple device configurations. obesity as well as the development of and installation of equipment to form novel auto-injector products delivering high-performance manufacturing lines. In the development of generic GLP-1 emergent therapies to target new treat- drug products, this adaptability can be ment opportunities. The key question, The unique design of the Aidaptus® used to accelerate the path to market then, is what can be done to ensure the device platform enables a user-friendly for an abbreviated new drug applica- potentially negative influence of time is injection experience for patients, and tion (ANDA) where reference therapies maintained within acceptable limits and provides customers with greater flexibi- have multiple dosing configurations or does not compromise success? lity through its ability to accommodate where the dosing varies over the course Stevanato Group’s answer comes in the both 1mL and 2.25mL syringes in the of treatment based on a combination of form of its collaborative partnership with same form factor. The device’s auto-adjust maintenance doses and additional dose Owen Mumford Pharmaceutical Services plunger technology seamlessly adapts to increments. Aidaptus enables this varia-® (OMPS), a pioneer in the auto-injector different fill volumes within the respective bility to be managed with comparative space whose portfolio includes the Aidap- syringe size without any requirement to ease by mirroring dosage forms – even tus auto-injector platform that embodies® change parts. This flexibility means the where they are of differing volumes – the well-established two-step single- Aidaptus platform is ideal for accommo-® within a single device type, reducing the use interface. As the exclusive contract dating a complex dosing regimen within manufacturing requirements involved in manufacturer and commercial partner a single device. As a result, the time and production. for Aidaptus, Stevanato Group brings® costs associated with development and However, the ability of Aidaptus to® 68 The Pharmaceutical Post 20 / Octobre - 2024