EXECUTIVE INTERVIEW - Owen Mumford & Stevanato Group: Collaborating to Produce Aidaptus® Auto-injector

Owen Mumford and Stevanato Group recently signed a deal to collaborate on the production and commercialization of Owen Mumford’s innovative Aidaptus^® auto-injector. Various benefits arise from combining their expertise. While Owen Mumford boasts expertise in device design, development, and production of drug delivery devices, Stevanato Group provides capabilities in component moulding, as well as sub-assembly and final assembly equipment, to provide its pharma customers with flexibility and confidence for their combination product development.

 Drug Development & Delivery recently interviewed Michael Earl, Director of Pharmaceutical Services at Owen Mumford, and Steven Kaufman, Vice President for Drug Delivery Systems at Stevanato Group to discuss their collaboration in producing the innovative Aidaptus auto-injector.

Q: Why did Owen Mumford Pharmaceutical Services (OMPS) and Stevananto Group (SG) decide to collaborate?

Michael Earl: The launch of Aidaptus as our latest innovative auto-injector presented OMPS with an exciting and unique opportunity, but also created some potential challenges for us. The market for disposable auto-injectors has shown significant growth in recent years due to a variety of market trends, such as an aging population with chronic diseases, the shift to remote patient treatment and self-administration, accelerated by the pandemic, and an increase in subcutaneous injection as a route of administration. So, while the size of the opportunity was apparent, we needed to ensure we could maximize this opportunity and be able to meet the potential demand for the product. We realized a collaboration with SG would provide the means for capacity scale up more flexibly than our own initial capabilities, while allowing us to expand our customer reach across the globe. We knew the collaboration would also provide our customers with assurance of our ability to manage supply of devices optimally, as partners, using the substantial combined resources available to us.

Steven Kaufman: From an SG perspective, the opportunity to be the exclusive partner on the manufacture of Aidaptus provided a perfect fit with our own core capabilities around precision plastic injection moulding and also gave us the opportunity to leverage our expertise in engineering and automation systems by offering sub-assembly and final assembly equipment. And of course, we can also offer customers a range of drug containment solutions for use within the device for both 1-ml and 2.25-ml prefilled syringes. Our global commercial footprint allows us to effectively amplify the Aidaptus sales and marketing efforts led by OMPS to identify more customers who have a need for such a device. OMPS and SG have many shared values and ways of conducting business that are critical to a successful collaboration.

Q: What does OMPS contribute to the collaboration?

Michael Earl: At OMPS, we have a long history designing, developing, and manufacturing auto-injectors, in fact we designed the first auto-injector, Autoject 1, and brought it to the market back in the mid 1980s. Since then, we have made a variety of different reusable and disposable auto-injectors for many pharmaceutical companies both small and large, including supplying the auto-injector for a world leading immunology treatment. So, we have proven expertise in supplying these products at scale over a sustained period of time. We were able to use this extensive knowledge of auto-injectors to help design Aidaptus as a true platform auto-injector and include unique features we believe will really benefit both pharma companies and their patients. We created Aidaptus with a wide design envelope that was subsequently demonstrated in our design verification testing, which showed its ability to work with a range of formulations, needle sizes, and primary containers, providing pharma companies with true flexibility.

Q: What are SG plans with respect to bringing the collaboration to life?

 Steven Kaufman: First, at SG we are excited to be involved as exclusive partners in such an innovative product from such an early stage of its commercialization. During the first phase, SG will provide precision plastic injection moulding services for Aidaptus components. We will also leverage our expertise in engineering and automation systems by offering sub-assembly services using equipment designed by our in-house automation team, and in addition, final assembly equipment from benchtop units to high-volume production can be provided as needed by our pharma customers. The sub-assembly equipment will be installed at both SG and OMPS production sites for dual sourcing options. Our commercial team will also work closely alongside the OMPS commercial team to help develop new customers and support existing ones. And with our sites in Europe and the US, we can also provide analytical services, especially related to drug containment solutions.

Michael Earl: Both parties are making investments now in building the capacity. We aim to have a capacity of several hundred thousand units in the coming months with a scale up to several million by 2024. For OMPS, the new assembly equipment will be installed at our new state-of-the-art facility in Witney, UK, which is due for completion in 2023. The Witney site has been designed in accordance with BREEAM certification environmental standards and as such, employs sustainable construction, operation, and design, so it fits well with our company sustainability objectives.

Q: How does the collaboration benefit pharma companies?

Michael Earl: Aidaptus is a true platform auto-injector, so we believe even if the drug formulation changes, the device does not need to. This obviously has advantages in reducing the work and risk associated with changes in formulation, such as additional verification testing, human factors studies, and regulatory documentation. This will all help to reduce time to market for the final combination product, a key element in today’s competitive marketplace.

Steven Kaufman: The combined resources, expertise, and manufacturing capabilities of OMPS and SG will help reduce complexity, reduce time-to-market, and minimize supply-chain risk and simplify final assembly for our pharma customers, and together, we can provide a true end-to-end solution for those customers who require more than just a device. In summary, we are hoping to reduce risk in our customers’ combination product development. And we help to ensure this by working together to offer greater support to pharma customers who have been looking for viable alternatives to “platform” auto-injectors that are well known to the market today. With both SG and OMPS offering this 1-ml and 2.25-ml hybrid device in a relatively compact form factor, we see several experienced pharma customers starting to evaluate features such as the adaptable plunger rod to support a range of fill volumes.

Q: What makes Aidaptus unique as an auto-injector?

Michael Earl: Aidaptus’ innovation lies in its unique design, allowing it to accommodate both 1-ml and 2.25-ml in the same compact-size base device, plus using its patented auto-adjust plunger technology, Aidaptus provides more flexibility as it has the ability to adapt to different fill volumes and plunger positions, without the need for any change parts. This essentially means the same device can be used irrespective of formulation changes that we know can frequently take place during drug development and also as part of life cycle management. So, this can help to reduce risk for our pharma partners as well as reduce time to market in combination product development.

Q: How does Aidaptus help patients?

Michael Earl: Aidaptus has a unique design that means it is simple and intuitive to use with clear visual and audible indicators, and yet the device remains compact in size (161 mm x 18.5 mm). This simplicity means the device can help facilitate self-administration for patients in the comfort of their home setting and at the same time, potentially reduce the need for visits with healthcare professionals, therefore saving time for all. Our approach to the human factor studies ensured the device could be used successfully by a range of intended users so that we are confident it can be used in a variety of therapeutic areas.