Benefits of a burgeoning partnership

Among the learnings from the COVID-19 pandemic was the need to build more resilient supply chains. Where possible, greater collaboration between industry players is an invaluable strategy in this endeavor, allowing companies to bring their respective strengths together, and better serve their customers.

In 2022, Owen Mumford Pharmaceutical Services (OMPS) and Stevanato Group partnered to amplify production of OMPS’ innovative Aidaptus© auto-injector. Owen Mumford contributes a depth of knowledge in device design, development, and production of drug delivery services while Stevanato Group provides capabilities in component molding, sub-assembly, and final assembly equipment.

Anticipating demand

The market for disposable auto- injectors has shown significant growth in recent years. Converging factors are driving demand: aging populations suffering from chronic diseases, the shift to remote patient treatment and self-administration (accelerated by the pandemic), and the growing popularity of subcutaneous injection as a route of administration.

The launch of the Aidaptus auto-injector presented OMPS with a significant opportunity but also created some challenges: the business needed to maximize the opportunity and meet potential product demand.

A strategic partnership would help overcome multiple hurdles. For OMPS, a collaboration with Stevanato Group would provide customers with assurance of the manufacturer’s ability to optimally manage device supply, using the substantial combined resources available. From Stevanato Group’s perspective, the prospect of being the exclusive partner for the manufacture of Aidaptus was a perfect fit with its core capabilities in precision plastic injection molding, drug containment solutions, and assembly equipment.

OMPS’ auto-injector expertise

Owen Mumford has a long history of designing, developing, and manufacturing auto-injectors. The company designed the first auto-injector, Autoject 1, and brought it to market in the mid-1980s. Since then, it’s made a variety of reusable and disposable auto- injectors for pharmaceutical companies. It has proven expertise in supplying these products at scale for a sustained period.

The OMPS team used this knowledge to design Aidaptus, a true platform auto-injector with a wide design envelope, meaning it’s compatible with a range of formulations, fill volumes, needle sizes, and primary containers – providing pharma companies with flexibility. Since there are often changes to formulation and dosage during development of injectable drug products, and throughout their life cycle, this flexibility is invaluable.

Specifically, it reduces the work and risk associated with changes in formulation such as additional verification testing, human factors studies, and regulatory documentation. It also helps reduce time to market for the final combination product (drug and device), a valuable asset in a dynamic industry where early market access is critical to commercial success.

Scalable manufacturing

Stevanato Group is collaborating as exclusive partners of this innovative product at an early stage of commercialization. Initially, Stevanato Group is providing precision molding services for Aidaptus components, drawing from the company’s knowledge and experience in industrialization through robust and scalable manufacturing processes.

Stevanato Group also offers sub-assembly services using equipment designed by the in-house automation team, leveraging its expertise in engineering and automation systems. This equipment will be installed at both Stevanato Group and Owen Mumford production sites for dual sourcing options. As part of a completely integrated auto-injector solution, customers have the option to choose Stevanato Group’s modular final assembly platforms to enable production scale up.

However, the partnership’s impact goes beyond manufacturing alone. Stevanato Group’s global commercial footprint means the company can effectively amplify Aidaptus sales and marketing efforts led by OMPS, by identifying more customers who have a need for such a device. The commercial team is working closely alongside the OMPS commercial team to develop new customers and support existing partners. With sites in Europe and the U.S., Stevanato Group can also provide analytical services, especially related to drug containment solutions.

Increasing capacity

Pairing Owen Mumford’s device expertise and final assembly capabilities with Stevanato Group’s portfolio of drug containment solutions and device manufacturing capabilities brings value to customers by reducing risk, up-front costs, and time-to-market.

Both parties are now making investments to further build capacity, strengthening the resilience of their supply chains to deal with any shocks to production. New assembly equipment will be installed at Owen Mumford’s facility in Witney in the UK, which is due for completion in 2023. The location of production facilities alongside the company headquarters allows OMPS to rapidly respond to issues, allowing the partnership to extend its reach so more customers can access the benefits of this innovative platform.

About the authors: Michael Earl, director, pharmaceutical services at Owen Mumford Ltd., has more than 35 years in all aspects and stages of drug and device development and commercialization. Steven R. Kaufman, vice- president of drug delivery systems, Stevanato Group, has been active in the drug delivery systems field for more than eighteen years.

Owen Mumford Pharmaceutical Services (OMPS):
https://www.ompharmaservices.com

Stevanato Group:
https://www.stevanatogroup.com