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INJECTION

DUAL CHAMBER
LEVERAGING LARGE-VOLUME PLATFORMS FOR LIQUID-LIQUID DRUG DELIVERY
Valerio Ravazzolo and Thomas James examine liquid-liquid drug delivery using Stevanato Group’s EZ-fill® 3 mL internal-bypass cartridge platform and SHL Medical’s Magnitude 3.0 autoinjector platform, demonstrating how these technologies can be integrated into a standardised container-device ecosystem, helping to reduce the cost, risk and development timelines traditionally associated with customised solutions for combination products.
DUAL CHAMBER
GAS-POWERED AUTOINJECTORS: MEETING THE CHALLENGES OF AN EVOLVING DRUG LANDSCAPE
Ram Halthore presents Kaleo's Aerio™ autoinjector platform, discussing how gas-powered autoinjectors have the potential to tackle the challenges currently facing injectable drug delivery, including high-viscosity and large-volume formulations, increased demand for patient-centricity and stringent regulatory requirements for reliability in emergency-use applications.
SIMPLIFYING COMBINATION THERAPIES: DUAL-INJECTION FUNCTIONALITY FOR EXISTING PLATFORM AUTOINJECTOR SYSTEMS
DUAL CHAMBER
Marc Flippe
BD (Becton Dickinson & Company)
SIMPLIFYING COMBINATION THERAPIES: DUAL-INJECTION FUNCTIONALITY FOR EXISTING PLATFORM AUTOINJECTOR SYSTEMS
Marc Flippe and Sophie Lelias discuss how dual-injection technology provides a promising approach to combination therapies and explain how, through the development of BD’s novel valve component, the company has reimagined dual injection within existing and established platform systems.
AHEAD OF THE CURVE: How Innovation Without Change<sup>®</sup> Delivers an End-to-End DUAL-CHAMBER Solution
DUAL CHAMBER
Sian Eden
Credence MedSystems
AHEAD OF THE CURVE: How Innovation Without Change® Delivers an End-to-End DUAL-CHAMBER Solution
Sian Eden and John Merhige consider how dual-chamber solutions have moved from a niche product to a mainstream consideration for stability-challenged formulations, offering formulation teams an alternative path to get these promising therapies into the hands of the patients that need them, and highlight how Credence is uniquely positioned to deliver on the potential of dual-chamber systems.
The Missing Middle of SC Drug Delivery: How a Dual-Cartridge Architecture Could Unlock the 3–10 mL Opportunity
DUAL CHAMBER
Dr Brent Buchine
Windgap Medical
The Missing Middle of SC Drug Delivery: How a Dual-Cartridge Architecture Could Unlock the 3–10 mL Opportunity
Dr Brent Buchine, Mike Ratigan and Aaron Mann argue that the industry’s traditional 2–3 mL boundary for subcutaneous injection reflects the limitations of conventional device and primary-container architectures more than the needs of any particular product or patient, considering whether two widely available cartridges, integrated into a single handheld system, could extend the simplicity and range of autoinjection.
Interview: Rethinking Drug Delivery for Increasingly Complex Therapies
INTERVIEW
Ram Halthore
KALEO
Interview: Rethinking Drug Delivery for Increasingly Complex Therapies
In this interview, Ram Halthore discusses the demands of newer classes of injectable drugs and the trend towards self-administration using conventional drug delivery systems, the requirements innovative systems must meet and the importance of selecting a delivery system early in formulation development, as well as the roles that robust human factors engineering and high reliability should play in device development.
CAPA VALVE LAUNCHES NEW VALVE SYSTEM FOR DUAL-CHAMBER DEVICES
DUAL CHAMBER
Dr Phil Green
Capa Valve
CAPA VALVE LAUNCHES NEW VALVE SYSTEM FOR DUAL-CHAMBER DEVICES
Dr Phil Green and Kevin Abbott discuss how Capa Valve’s patented valve technology provides a compelling alternative to bypass-based dual-chamber syringes, as its pressure-sensitive valve-based design enables much greater compatibility with existing fill-finish infrastructure and offers the flexibility to precisely tune the device via the geometric position of the valve within the syringe barrel.
PROACTIVE QUALITY AND REGULATORY ENGAGEMENT TO ACCELERATE PRODUCT DEVELOPMENT
PHARMA VIEW
Bharat Arora
PROACTIVE QUALITY AND REGULATORY ENGAGEMENT TO ACCELERATE PRODUCT DEVELOPMENT
Bharat Arora and Hirak Bhatiya Pharmaceuticals discuss the quality and regulatory perspective on accelerated development pathways transitioning from an emergency measure to a mainstream route to commercialisation, going over what may be expected of pharmaceutical quality teams to manage this new paradigm.
ENABLING DELIVERY OF LYOPHILISED BIOLOGICS VIA SIMULATION-LED DEVELOPMENT OF DUAL-CHAMBER SYSTEMS
EXPERT VIEW
Dr Sahab Babaee
ENABLING DELIVERY OF LYOPHILISED BIOLOGICS VIA SIMULATION-LED DEVELOPMENT OF DUAL-CHAMBER SYSTEMS
Dr Sahab Babaee and Dr Matthew Hancock discuss the potential of using modelling and simulation when designing dual-chamber injection devices, which can enable device designers to investigate the complex interactions that take place within a dual-chamber system without a physical prototype and discover potential failure modes much earlier in the design process.
UNSTACKING THE DUAL-CHAMBER SYRINGE: A CARTRIDGE-BASED PATH TO RELIABLE RECONSTITUTION
DUAL CHAMBER
Eric Sugalski
Ampulis
UNSTACKING THE DUAL-CHAMBER SYRINGE: A CARTRIDGE-BASED PATH TO RELIABLE RECONSTITUTION
Eric Sugalski and Tom Handel introduce Pristal, the cartridge-based reconstitution platform from Ampulis, and explain how it overcomes some of the usability, manufacturing and supply-chain challenges that have limited stacked dual-chamber syringes.
HIGH-CONCENTRATION, HIGH-VISCOSITY DELIVERY WITH CORE-ANNULAR FLOW
EARLY INSIGHT
Dr Simon Rufer
CoFlo Medical
HIGH-CONCENTRATION, HIGH-VISCOSITY DELIVERY WITH CORE-ANNULAR FLOW
Dr Simon Rufer and Pratik Mishra introduce CoFlo Medical ’s core-annular flow platform, which promises to eliminate the long-standing viscosity bottleneck for needle-based delivery. The company’s platform enables high-concentration, high-viscosity delivery for existing formulations without the need for reformulation or new compounds in a patient-friendly form.
RECONSTITUTION TO CO-DELIVERY: DESIGNING MULTICHAMBER DEVICES FOR BETTER PATIENT EXPERIENCES
EXPERT VIEW
Jack Dunkley
RECONSTITUTION TO CO-DELIVERY: DESIGNING MULTICHAMBER DEVICES FOR BETTER PATIENT EXPERIENCES
Jack Dunkley delves into the architectural principles of multichamber systems for injectable formulations and considers how to overcome the design challenges involved.
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.
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.
BEYOND DRUG DELIVERY: THREE LENSES FOR SELECTING AN ON-BODY PLATFORM
WEARABLES
Reto Jost
Ypsomed
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
WEARABLES
Dan Yates
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
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.
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