ONdrugDelivery | Global Drug Delivery Industry Information & Intelligence

WEARABLES

WHY SMARTER WEARABLES ARE THE SIMPLE ANSWER TO INTELLIGENT DRUG DELIVERY

Dr Greg Moakes considers how complex devices such as LTS’s Sorrel™ on-body delivery system can facilitate the self-administration of injectable therapies while continuously monitoring and verifying the device’s critical delivery functions.

SCALING ON-BODY DELIVERY FOR LARGE-VOLUME THERAPIES

Mike Stout and Dr Oliver Eden examine the shift towards large-volume SC administration, what on-body delivery systems make possible and why bringing them to market at scale depends as much on manufacturing as on design.

LIMITS SHATTERED: ENDING THE AUTOINJECTOR AND WEARABLE INJECTOR DIVIDE

Dr Scott Russo questions the distinction between wearable injectors and autoinjectors, making the case that it is not fundamental to device design, rather it is an outdated segmentation that results in unnecessary design trade-offs. He introduces MiniGo, a next-generation platform device that aims to overcome this false dichotomy.

Off The Critical Path: Bringing Device Strategy Forward In Combination Product Development

Ventura Solutions

Off The Critical Path: Bringing Device Strategy Forward In Combination Product Development

David Karvani and Greg Moakes discuss how early collaboration with device development partners can help pharma companies navigate the technical and regulatory complexities of combination product development.

INDUSTRIAL ARCHITECTURE: THE NEXT COMPETITIVE ADVANTAGE IN WEARABLE INJECTORS

INDUSTRIAL ARCHITECTURE: THE NEXT COMPETITIVE ADVANTAGE IN WEARABLE INJECTORS

Andy Wertheim puts forward the case that wearable drug delivery devices comprise two separate architectures – therapeutic and industrial – that must be developed and implemented in tandem if a development programme is to achieve long-term commercial success.

BEYOND DRUG DELIVERY: THREE LENSES FOR SELECTING AN ON-BODY PLATFORM

BEYOND DRUG DELIVERY: THREE LENSES FOR SELECTING AN ON-BODY PLATFORM

Reto Jost, Nadine Kaufmann and Shawn James discuss three complementary decision lenses and explain how they offer a practical framework for evaluating early platform decisions that can shape outcomes across the entire product lifecycle.

WEAR IT WELL: HOW ON-BODY DELIVERY SYSTEMS HAVE EVOLVED TO EMPOWER PATIENTS AND EMBOLDEN INNOVATORS

West Pharmaceutical Services

WEAR IT WELL: HOW ON-BODY DELIVERY SYSTEMS HAVE EVOLVED TO EMPOWER PATIENTS AND EMBOLDEN INNOVATORS

Dan Yates considers how wearables have increased their value for both patients and pharma partners through intentional design optimisation, highlighting how insights from real-world use have led to intentional design directions that satisfy the needs of these critical stakeholder groups, further building confidence in a configurable platform that maintains significant potential for future innovation.

CONSISTENCY IN LARGE-VOLUME BIOLOGIC DRUG DELIVERY: WHY TISSUE BACKPRESSURE MATTERS

CONSISTENCY IN LARGE-VOLUME BIOLOGIC DRUG DELIVERY: WHY TISSUE BACKPRESSURE MATTERS

Andrew Moore discusses the importance of backpressure and its variance across the patient population when designing an infusion system for large-volume biologics, including how Gerresheimer’s Gx InPuls and Gx InPuls Flex infusors are able to adapt to this variance dynamically to ensure a consistent patient experience.

THE PERCEPTION PROBLEM WITH SC VOLUME LIMITS AND ITS DRUG DEVELOPMENT COST

Dr Haydon DuMond

Enable Injections

THE PERCEPTION PROBLEM WITH SC VOLUME LIMITS AND ITS DRUG DEVELOPMENT COST

Dr Haydon DuMond, Dr Mehul Desai, along with Dr Shirish Ingawale, examine survey evidence and regulatory precedent showing that the widely cited 2–3 mL limit on subcutaneous delivery reflects device history and information habits rather than tissue biology, and consider the consequences for formulation strategy, device selection and the growing pipeline of large-volume subcutaneous therapies.

DESIGN VERIFICATION FOR THE REAL WORLD: COMPLEX DRUG DELIVERY IN UNCONTROLLED ENVIRONMENTS

Dr Matthew Roberts

DESIGN VERIFICATION FOR THE REAL WORLD: COMPLEX DRUG DELIVERY IN UNCONTROLLED ENVIRONMENTS

Dr Matthew Roberts and Andrew Fiorini explore the key steps involved in building a successful design verification programme for ambulatory electromechanical infusion systems and share the lessons they have learned along the way.

FROM SPACE PROPULSION TO DRUG DELIVERY: A NEW SUBCUTANEOUS PLATFORM FROM TORRAMICS

FROM SPACE PROPULSION TO DRUG DELIVERY: A NEW SUBCUTANEOUS PLATFORM FROM TORRAMICS

David Johnston introduces the NanoFlow platform, a wearable injector based on semiconductor architecture rather than a traditional mechanical pump, enabling enhanced dosing precision and further miniaturisation than is possible with legacy systems.

Designing a Wearable Drug Delivery Pump

Dr Sammy Hassan

Designing a Wearable Drug Delivery Pump

Dr Sammy Hassan delves into the measures required to ensure safe and reliable use of wearable drug delivery pumps, explaining the difficulties and benefits of incorporating such standards into a device.

Ultrasonic Joining Process Ensures Reliable Assembly of Sensitive CGM Components

INDUSTRIALISATION

Fabio Weingärtner

Herrmann Ultraschall

Ultrasonic Joining Process Ensures Reliable Assembly of Sensitive CGM Components

Fabio Weingärtner discusses the value of ultrasonic welding for wearable diagnostic and drug delivery devices, using a continuous glucose monitor developed by GlucoModicum as a case study, describing the joining challenges for distinct, delicate components and the innovative solutions produced to overcome complex design requirements.

Company Showcase: Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing

Company Showcase: Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing discusses its sterile filling capabilities and how its expanding facilities support growing demand for vial, syringe and cartridge filling.

THE HIDDEN RISKS IN DRUG-DEVICE DELIVERY: WHY THE FINAL STAGE DEFINES LAUNCH SUCCESS

THE HIDDEN RISKS IN DRUG-DEVICE DELIVERY: WHY THE FINAL STAGE DEFINES LAUNCH SUCCESS

John Ward and Paul Hamill explore the structural and operational risks embedded in late-stage drug-device delivery, why these risks are intensifying and how the industry is beginning to rethink its approach to downstream execution.

INNOVATION AND AUTOMATION REUNITED – ENABLING SCALABLE FINAL ASSEMBLY FOR CARTRIDGE-BASED AUTOINJECTORS

INDUSTRIALISATION

INNOVATION AND AUTOMATION REUNITED – ENABLING SCALABLE FINAL ASSEMBLY FOR CARTRIDGE-BASED AUTOINJECTORS

Using SHL Medical's Reunite™ dual-chamber autoinjector and SHL Advantec's AOU™ assembly machine platform as a case study, Christy Chen and Alberto Flores explore the critical synergy between flexible automation architecture and expert final assembly services.

INJECTION-MOULDED PROTOTYPES FROM 3D-PRINTED TOOLING: ACCELERATING DRUG DELIVERY DEVICE DEVELOPMENT

INDUSTRIALISATION

INJECTION-MOULDED PROTOTYPES FROM 3D-PRINTED TOOLING: ACCELERATING DRUG DELIVERY DEVICE DEVELOPMENT

David Valencia and Martí Giralt discuss the value that 3D-printed tooling can bring to prototyping injection-moulded components for drug delivery devices, enabling rapid turnaround and iteration of designs while remaining functionally representative of the final commercial parts.

LYOPHILISATION VIALS: QUICK AND EFFECTIVE SOLUTIONS TO REDUCE FOGGING

INDUSTRIALISATION

Diane McCormick

NIPRO PharmaPackaging

LYOPHILISATION VIALS: QUICK AND EFFECTIVE SOLUTIONS TO REDUCE FOGGING

Diane McCormick and Clément Condouret discuss lyophilisation fogging, explaining its negative downstream effects and presenting NIPRO’s thermal treatment, VIALEX™, to minimise this issue.

PHARMASHELL – AN ALD NANOCOATING TECHNOLOGY FOR ONCE-MONTHLY INJECTABLES

Dr Anders Johansson

PHARMASHELL – AN ALD NANOCOATING TECHNOLOGY FOR ONCE-MONTHLY INJECTABLES

Dr Anders Johansson, Dr Polla Rouf and Dr Oliver Hedge introduce Nanexa’s PharmaShell^® technology and discuss how, in combination with nanotechnology, it can achieve previously unattainable dosing intervals with standard formulations.

DESIGNING FOR SCALE: RELIABLE MANUFACTURING OF PEN INJECTOR PLATFORMS

INDUSTRIALISATION

Phillips Medisize

DESIGNING FOR SCALE: RELIABLE MANUFACTURING OF PEN INJECTOR PLATFORMS

Henrik Leisner discusses the reliable scaling of pen injector programmes, considering how high-quality, high-volume manufacture depends on experience and collaboration.

INDUSTRIALISING DRUG DELIVERY DEVICES: INSIGHTS FROM 40 YEARS OF GETTING TO MARKET

Chris Hurlstone

INDUSTRIALISING DRUG DELIVERY DEVICES: INSIGHTS FROM 40 YEARS OF GETTING TO MARKET

Chris Hurlstone looks at the process of developing drug delivery systems through the industrialisation phase and explores ways to address the challenges that arise along the way. Drawing on Team’s 40-year track record of supporting drug delivery device innovation, the insights are intended for teams involved in developing drug delivery systems, particularly those responsible for design, engineering, industrialisation and manufacturing transfer.

INDUSTRIALISING DRUG DELIVERY IN AN UNCERTAIN WORLD

INDUSTRIALISATION

INDUSTRIALISING DRUG DELIVERY IN AN UNCERTAIN WORLD

Andy Wertheim considers how the priorities of drug delivery device industrialisation have shifted in response to the major supply chain shocks of recent years, with companies shifting their focus from purely optimising for low cost and putting much greater emphasis on security and continuity, and what these changing priorities imply for the industry as a whole.

FLYING ON TWO WINGS: YPSOMED’S DUAL-ENGINE STRATEGY FOR SUCCESS IN CHINA

INDUSTRIALISATION

FLYING ON TWO WINGS: YPSOMED’S DUAL-ENGINE STRATEGY FOR SUCCESS IN CHINA

Hong Cui, Orfeo Niedermann and Shawn James discuss how Ypsomed has succeeded in China, highlighting the importance of integrating into the local market, keeping in stride with the pace of development and maintaining alignment with global quality standards.

DE-RISKING POST-MARKET CHANGE THROUGH PILOT PRODUCTION

DE-RISKING POST-MARKET CHANGE THROUGH PILOT PRODUCTION

Jon Powell explores how pilot production, delivered through integrated design, development and manufacturing capabilities, can be used to de-risk change in commercial-scale drug delivery devices, highlighting how such approaches can improve confidence in decision-making while reducing overall time and cost.

HOW MODERN PROTOTYPING ACCELERATES DRUG DELIVERY DEVICE DEVELOPMENT

INDUSTRIALISATION

Erwin van Huijksloot

HOW MODERN PROTOTYPING ACCELERATES DRUG DELIVERY DEVICE DEVELOPMENT

Erwin van Huijksloot and Joe Melton discuss the importance of early prototyping, ensuring a strong understanding of production efficiency and possible variability is grasped before large-scale manufacture begins.

Technology Showcase: DIGITAL TWIN TECHNOLOGY FOR AUTOINJECTORS

Technology Showcase: DIGITAL TWIN TECHNOLOGY FOR AUTOINJECTORS

Covestro outlines how digital twin methodologies, physics-based virtual models spanning structural testing, drop-test simulation and injection-moulding analysis, are helping engineers develop polycarbonate autoinjector components, reducing physical prototyping, tooling iterations and time to market while maintaining safety and reliability.

EFFICIENCY, DATA INTEGRITY AND QUALITY ASSURANCE IN THE PRODUCTION OF INSULIN PENS

EFFICIENCY, DATA INTEGRITY AND QUALITY ASSURANCE IN THE PRODUCTION OF INSULIN PENS

Stephan Vogel discusses the role of advanced monitoring technologies in high-volume medical device manufacturing, considering the key role they play in ensuring quality and compliance with regulatory requirements and how analysing data centrally can support consistency across lines and sites.

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