Pharma Focus Europe

Stevanato Group Collaborates with Recipharm to Develop and Manufacture Pre-fillable Syringes for Use in a New Soft Mist Inhaler for the Inhalation of Sensitive Biological Products

Friday, March 17, 2023

Stevanato Group S.p.A. a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced a collaboration with leading Contract Development and Manufacturing Organisation (CDMO), Recipharm. Under the agreement, Stevanato Group will lend its 70+ years of manufacturing experience to support the development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers. As part of this collaboration, Stevanato Group will provide and manufacture its glass pre-fillable syringe Alba® assembled with the Integrated Spray Module (ISMTM) of Recipharm’s soft mist inhaler technology, the Pre-Filled Syringe Inhaler (PFSITM).

This collaboration highlights Stevanato Group’s capabilities as a one-stop shop offering contract drug manufacturing organizations support in their drug development programs, from the clinical phase through to market release. Stevanato Group’s Alba® syringes feature an internal coating based on silicone oil, which is cross-linked with the glass surface, thereby minimizing sub-visible particle release and aiming to ensure superior performance during delivery.

The combination of the Alba® syringe and Recipharm's innovative soft mist inhaler technology delivers sensitive drug products more efficiently to the respiratory airways and provides biopharma companies with a containment solution featuring enhanced stability and safety. With Stevanato Group taking responsibility for the complete primary drug package, Recipharm’s focus is on the design and manufacture of the spray technology, the inhalation device, and the fill and finish of the product.

Recipharm’s soft mist inhaler (PFSI™) is developed, manufactured, and licensed by Resyca® and is supplied as a pre-filled and ready-to-use inhalation device.

Bernhard Muellinger, General Manager and Chief Operational Officer at Resyca® (a joint venture between Recipharm and Medspray), said: “By leveraging Stevanato Group's integrated capabilities, from plastic injection molding and assembly capabilities to comprehensive scientific and analytical support services, we will be able to offer a turnkey solution, and accelerate and de-risk our pharmaceutical customers’ development programs. This is particularly true for novel inhaled biological products.”

“Biopharma companies are advancing patient care with new, innovative treatments, particularly in biologics and mRNA therapies. These products require specialized, high-performance drug containment systems, like our Alba® syringe platform, together with patient-centric drug delivery devices like the PFSI™. Thanks to our integrated end-to-end capabilities we are able to support our customers at scale with a comprehensive system solution,” said Mauro Stocchi, CBO of Stevanato Group.

Franco Moro, CEO of Stevanato Group, noted: “Creating a network of strategic collaboration partners is an important element of our long-term strategy to match customers’ needs and address self-administration trends in patient care with user-friendly drug delivery devices that provide variable and accurate dosing. This agreement marks another key step in broadening our high-value solutions and integrated capabilities as we continue to diversify and enhance our presence in the drug delivery market of pen injectors, auto-injectors, inhalers, and wearable pods.”



Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024