2022_Sep_ConnectinPharma_Easyfairs_Geneva

INTERVIEW: STEVEN KAUFMAN, STEVANATO GROUP, & MICHAEL EARL, OWEN MUMFORD

To Issue 133

Citation: “Interview: Steven Kaufman, Stevanato Group, & Michael Earl, Owen Mumford”. ONdrugDelivery Online, May 12, 2022

In this exclusive interview, Steven Kaufman of Stevanato Group, and Michael Earl of Owen Mumford, talked with us about their companies’ recent major agreement for the manufacturing and provision of prefillable syringes for the advanced two-step, single-use autoinjector, Aidaptus®

Both  companies will be exhibiting at Pharmapack Europe, Paris, France, May 18-19, 2022, Stevanato at Booth B56 and B58, and Owen Mumford Pharmaceutical Services at Booth C52. They would be pleased to see you there.

Q To begin, please would you give an overview of the Aidaptus® device?

“In recent years, device developers have transitioned to platform technologies that can be modified to a wide variety of indications and clinical needs. Aidaptus takes this to the next level with its ability to adapt to different viscosities, syringe sizes and fill volumes, while maintaining the exact same form factor. These parameters will often change during development or life-cycle management but, with Aidaptus the device, it doesn’t. This is a game-changer for biopharma companies.”

ME Aidaptus® is a two-step, single-use autoinjector platform with a versatile design that accommodates both 1 mL and 2.25 mL prefilled glass syringes in the same base device. It also features plunger sensing technology with a self-adjusting plunger rod that automatically adapts to the individual plunger positions and different fill volumes in each syringe, with no change parts required. Aidaptus is able to accommodate a unique variety of drug viscosities.

Given the platform design of the device it can be used for a range of drugs indicated for subcutaneous (SC) delivery and hence is applicable for multiple indications. To support this, our human factors approach ensured that we looked at a wide range of intended patient groups with different ages and those with physical and cognitive impairments were included in the sampling. Aidaptus has been designed to facilitate the growing market for SC injections used to treat a variety of chronic diseases like rheumatoid arthritis, Crohns’ disease and multiple sclerosis.

SK In recent years, device developers have transitioned to platform technologies that can be modified to a wide variety of indications and clinical needs. Aidaptus takes this to the next level with its ability to adapt to different viscosities, syringe sizes and fill volumes, while maintaining the exact same form factor. These parameters will often change during development or lifecycle management but, with Aidaptus the device, it doesn’t. This is a game-changer for biopharma companies.

“Stevanato Group will mold the components for Aidaptus and provide final and sub-assembly equipment, while also offering market-leading prefillable syringes to enable pharmaceutical customers to create the final product for patient use.”

Q Please give us a run-down of specifics of this recent agreement on Aidaptus between your two companies.

ME The agreement makes Stevanato Group an exclusive manufacturing partner for the device, offering a full set of capabilities to its pharmaceutical customers. Stevanato Group will mold the components for Aidaptus and provide final and sub-assembly equipment, while also offering market-leading prefillable syringes to enable pharmaceutical customers to create the final product for patient use. Assembly of the components will be undertaken by both Stevanato Group at its global manufacturing sites, and by Owen Mumford at its automated assembly centre of excellence in the UK.

SK Putting it in its simplest form, this agreement means that Stevanato Group is now the exclusive contract manufacturer for Aidaptus. During the first phase, Stevanato Group will provide precision molding services for Aidaptus® components. This is where our knowledge and experience of implementing industrialisation plans through robust and scalable manufacturing processes comes into play. 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. This equipment will be installed at both Stevanato Group and Owen Mumford production sites for dual sourcing options.

Q How does this partnership offer value to pharma / biopharma customers and, ultimately, to patients?

“Often during development or lifecycle management of injectable drug products, changes in these parameters can occur. Now, for the first time, the device does not have to be changed as well.”

ME For our pharma/biopharma customers, this autoinjector can help reduce complexity, minimise supply-chain risk and simplify final assembly, thanks to its ability to adapt to different viscosities, syringe sizes and fill volumes. Often during development or lifecycle management of injectable drug products, changes in these parameters can occur. Now, for the first time, the device does not have to be changed as well.  Forming a collaboration with Stevanato Group provides additional reach to enable more customers to benefit from the advantages of this innovative platform, and assure customers of our ability to manage supply of devices optimally, as partners, using the substantial combined resources available to us.

For patients, this is an easy-to-use, two-step autoinjector that will enable home medication of SC medications without the need for visits to the clinic, and is a convenient size (161mm x 18.5mm), whether for the 1 mL or 2.25 mL syringe.

SK There are a lot of synergies between the companies and together we can offer a true end-to-end solution. Owen Mumford’s world-class device expertise and final assembly capabilities, together with Stevanato Group’s portfolio of drug containment solutions (glass primary packaging) and device manufacturing capabilities, will bring added value to customers by reducing risk, up-front costs, and time-to-market. The synergies of these capabilities and services will bring the confidence and stability of supply that biopharma companies require, and peace of mind to patients – knowing that their product has been designed and manufactured to the highest standards.

“Stevanato continues to be impressed with Owen Mumford’s positivity and company culture. When combined with our state-of-the-art contract manufacturing services, industry leading engineering capabilities and portfolio of drug containment solutions, we feel this collaboration becomes a compelling offering within the industry.”

Q Steven, what does Stevanato Group bring to the table as a partner in this collaboration? Why did you choose to partner with Owen Mumford?

SK I have great respect for Owen Mumford. Their experience in the industry is second to none, having produced one of the earliest and most successful autoinjectors in the market. They have a wealth of knowledge and experience with launched devices and post-market surveillance, which is so important to biopharma partners. Stevanato continues to be impressed with Owen Mumford’s positivity and company culture. When combined with our state-of-the-art contract manufacturing services, industry leading engineering capabilities and portfolio of drug containment solutions, we feel this collaboration becomes a compelling offering within the industry.

Q Michael, what does Owen Mumford bring to the table as a partner in this collaboration? Why did you choose to partner with Stevanato Group?

“In Stevanato Group we have a reliable and expert manufacturing partner as part of our combined supply chain, and can provide customers with a wide range of additional services relevant to their development of combination products, such as primary container expertise and final assembly equipment.”

ME Aidaptus is an Owen Mumford designed and developed device, responding to the needs of the pharma/biopharma customer base for flexibility and a true platform. The design work included all the required manufacturing and assembly optimisation, and the device verification testing has demonstrated the ability of the device to manage a wide range of syringe, drug, formulation, needle combinations across its design envelope. In Stevanato Group we have a reliable and expert manufacturing partner as part of our combined supply chain, and can provide customers with a wide range of additional services relevant to their development of combination products, such as primary container expertise and final assembly equipment where required.

Q How does this collaboration fit into Owen-Mumford’s broader overall strategy in the medium and long term?

ME We will continue to innovate in the field of drug delivery with the intention of serving our customer base, and ultimately patients, with value-added patient-centric devices. As and when partnering on specific opportunities can make sense in the future, we will be open to evaluating similar arrangements.

Both  companies will be exhibiting at Pharmapack Europe, Paris, France, May 18-19, 2022, Stevanato Group at Booth B56 and B58, and Owen Mumford Pharmaceutical Services at Booth C52. They would be pleased to see you there.

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