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INJECTION

WEARABLES
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.
WEARABLES
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.
WHY SMARTER WEARABLES ARE THE SIMPLE ANSWER TO INTELLIGENT DRUG DELIVERY
WEARABLES
Dr Greg Moakes
LTS
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
WEARABLES
Dr Oliver Eden
TxSphere
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
WEARABLES
Dr Scott Russo
Synolus Medical
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wearable injectors and autoinjectors, making the case that it is not fundamental to device design, rather it is an outdated segmentation that results in unnecessary design trade-offs.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
INTERVIEW
David Karvani
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
EXPERT VIEW
Andy Wertheim
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.
CONSISTENCY IN LARGE-VOLUME BIOLOGIC DRUG DELIVERY: WHY TISSUE BACKPRESSURE MATTERS
WEARABLES
Andrew Moore
Gerresheimer
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
WEARABLES
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
EXPERT VIEW
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
EARLY INSIGHT
David Johnston
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
EXPERT VIEW
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
SHOWCASE
Chelsea Keeton
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.
INNOVATION AND AUTOMATION REUNITED – ENABLING SCALABLE FINAL ASSEMBLY FOR CARTRIDGE-BASED AUTOINJECTORS
INDUSTRIALISATION
Christy Chen
SHL Advantec
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.
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
FORMULATION
Dr Anders Johansson
Nanexa
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
Henrik Leisner
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
EXPERT VIEW
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
Andy Wertheim
Quvara Medical
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.
DE-RISKING POST-MARKET CHANGE THROUGH PILOT PRODUCTION
EXPERT VIEW
Jon Powell
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
IGS GeboJagema
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
SHOWCASE
Covestro LLC
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.
Testing Prefilled Syringes to ISO 11040
INJECTION
Landon Goldfarb
Instron
Testing Prefilled Syringes to ISO 11040
Instron's Landon Goldfarb talks through ISO 11040, a testing standard that addresses the design and functional properties of prefilled syringes.
Interview: Celebrating 10 Years of Molly Enabling Patients’ Independence
INTERVIEW
Nicholas Heaton
SHL Medical
Interview: Celebrating 10 Years of Molly Enabling Patients’ Independence
Nicholas Heaton looks back on the decade since Molly – SHL Medical’s signature two-step autoinjector platform – was launched onto the market, reviewing what made the device platform a success, where Molly is positioned in the market today and how it will continue to evolve to meet the demands of the future.
FROM SMALL TO LARGE MOLECULES: ADVANCING PRECISION PUMP TECHNOLOGY FOR BIOLOGIC DRUG DELIVERY
WEARABLES
Dr Ines Rüstenberg
Gerresheimer
FROM SMALL TO LARGE MOLECULES: ADVANCING PRECISION PUMP TECHNOLOGY FOR BIOLOGIC DRUG DELIVERY
Dr Ines Rüstenberg, Roger Müller and Dr Yannick Schmid, discuss solutions for large-molecule drug delivery, highlighting the applicability of two infusors, Gx InPuls and Gx InPuls Flex, which employ micropump technology to overcome challenges with large-molecule delivery.
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