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EXPERT VIEW

EXPERT VIEW
THE SUSTAINABILITY ESCAPE ROOM: HOW PRIMARY PACKAGING TRIES TO GET OUT OF THE EU REGULATORY MAZE
Dr Bettine Boltres, Joe Monfort and Dana Smith break down the key EU regulatory layers affecting primary pharmaceutical packaging authorisations and explain why sustainability decisions require lifecycle thinking rather than single-attribute claims.
EXPERT VIEW
BIOPLASTICS IN DRUG DELIVERY: SUSTAINABLE SOLUTION OR SUBSTITUTION TRAP?
Serena Grace and Alex Fong examine the environmental and supply-chain limits of bio-based plastics in drug delivery, arguing that material substitution alone cannot address the sector’s deep dependence on virgin plastics. They consider how reducing raw material dependence can contribute not only to lowering carbon footprints but also to increasing supply-chain resilience, and highlight the importance of assessing, not assuming, impact.
WHY THE GREENEST POLYMERS NEVER REACHED SCALE
EXPERT VIEW
Athanasios Garoufas
WHY THE GREENEST POLYMERS NEVER REACHED SCALE
Athanasios Garoufas and Laura Armenio discuss how the sustainability profile of a material is baked-in at its production, examining how traditional methods for producing polymers fail to unify both environmentally favourable feedstock and industrial-scale production capacity, and consider the advantages that next-generation methods that bring these two key aspects together could bring to not only drug delivery but the wider industry.
THE OVERLOOKED SUSTAINABILITY LEVER: HUMAN FACTORS IN DRUG DELIVERY
EXPERT VIEW
Adrian Segens
THE OVERLOOKED SUSTAINABILITY LEVER: HUMAN FACTORS IN DRUG DELIVERY
Adrian Segens and Robin Huedepohl consider the effects of device design choices on environmental impact, looking at how design decisions can be optimised to reduce drug or device wastage, improve benefits for patients and ultimately minimise carbon footprints.
DESIGNING FOR A WORLD UNDER STRAIN: THE ROLE OF ECO-DESIGN IN IMPROVING SUSTAINABILITY AND SUPPLY-CHAIN SECURITY
EXPERT VIEW
Rob Veasey
DESIGNING FOR A WORLD UNDER STRAIN: THE ROLE OF ECO-DESIGN IN IMPROVING SUSTAINABILITY AND SUPPLY-CHAIN SECURITY
Rob Veasey discusses the core concepts of eco-design as applied to drug delivery devices, examining how sustainability principles can improve not only the environmental impact of the industry’s products and processes but also how they can contribute to better supply-chain robustness and resilience.
REDUCING COMMERCIALISATION RISK IN DRUG DELIVERY DEVELOPMENT
EXPERT VIEW
Dr Frank Engel Rasmussen
REDUCING COMMERCIALISATION RISK IN DRUG DELIVERY DEVELOPMENT
Dr Frank Engel Rasmussen and Mark Ypsilantis discuss how early decisions on functional device design affect downstream production choices, highlighting the importance of integrating scale-up considerations from the outset, across all development teams.
FROM FRAGMENTED PROCUREMENT TO INTEGRATED ASSEMBLY: HOW THE INJECTABLE DEVICE INDUSTRY IS RETHINKING EQUIPMENT STRATEGY
EXPERT VIEW
Jordan Xu
FROM FRAGMENTED PROCUREMENT TO INTEGRATED ASSEMBLY: HOW THE INJECTABLE DEVICE INDUSTRY IS RETHINKING EQUIPMENT STRATEGY
Jordan Xu examines the shift from fragmented procurement to integrated, turnkey assembly solutions, exploring the deep technical and regulatory drivers behind this evolution as the industry increasingly recognises that the real differentiator is not the speed of individual machines but the seamless integration of the entire assembly process.
CANNULA SELECTION FOR PREFILLED SYRINGE APPLICATIONS
EXPERT VIEW
Dr Wenzel Novak
CANNULA SELECTION FOR PREFILLED SYRINGE APPLICATIONS
Dr Wenzel Novak and Stephan Schatz discuss the considerations that go into optimising cannula selection for an injection device, including patient comfort, drug requirements, manufacturability and intended use case, arguing that the best selection will be one that successfully balances these factors rather than maximising a single parameter.
GETTING OUT OF A JAM: SUSPENSION DELIVERY, OCCLUSION AND DEVICE DESIGN
EXPERT VIEW
Dr Alex Vasiev
GETTING OUT OF A JAM: SUSPENSION DELIVERY, OCCLUSION AND DEVICE DESIGN
Dr Alex Vasiev discusses suspension-based parenteral systems, including micro- and nanoparticle suspensions and colloidal dispersions, where sedimentation, mechanical bridging and interfacial forces can strongly influence delivery performance.
PLATFORMS IN BIOPHARMA DEVICE DEVELOPMENT: FROM PRACTICE TO STRATEGY
EXPERT VIEW
Tim Quigg
PLATFORMS IN BIOPHARMA DEVICE DEVELOPMENT: FROM PRACTICE TO STRATEGY
Tim Quigg, Katie Ogden with Dr Shirish Ingawale discuss some of the key points from the 2026 PFS & Injectable Drug Devices East Coast Conference regarding biopharma platform technology.
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.
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.
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.
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.
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.
THE HIDDEN RISKS IN DRUG-DEVICE DELIVERY: WHY THE FINAL STAGE DEFINES LAUNCH SUCCESS
EXPERT VIEW
John Ward
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.
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.
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.
EFFICIENCY, DATA INTEGRITY AND QUALITY ASSURANCE IN THE PRODUCTION OF INSULIN PENS
EXPERT VIEW
Stephan Vogel
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.
ORAL DELIVERY OF MACROMOLECULES: CHALLENGES AND OPPORTUNITIES FOR DEVICE-ENABLED GI DELIVERY
EXPERT VIEW
Dr Sahab Babaee
ORAL DELIVERY OF MACROMOLECULES: CHALLENGES AND OPPORTUNITIES FOR DEVICE-ENABLED GI DELIVERY
Dr Sahab Babaee discusses the potential of device-based approaches to enable the delivery of macromolecules via the gastrointestinal tract, considering the constraints and possibilities of mucosal delivery devices, as well as the technologies currently being investigated to make this potential a reality.
TRANSDERMAL DRUG DELIVERY: ENHANCING PERMEABILITY AND IN VIVO TRANSLATION
EXPERT VIEW
Leo Pan
TRANSDERMAL DRUG DELIVERY: ENHANCING PERMEABILITY AND IN VIVO TRANSLATION
Dr Leo Pan provides insights into the field of transdermal drug delivery and investigates the two primary approaches being taken to advance the sector – enhancing the ability of drugs to permeate through the skin barrier and translating in vitro data to an in vivo reality.
ANTIBODY-DRUG CONJUGATES: AN EMERGING FRONTIER IN IV TO SC CONVERSION
EXPERT VIEW
Dr Mehul Desai
ANTIBODY-DRUG CONJUGATES: AN EMERGING FRONTIER IN IV TO SC CONVERSION
Dr Mehul Desai, Dr Michael Hageman and Dr Wei Chen examine the growing antibody-drug conjugate market, the unique formulation challenges these therapies present for subcutaneous delivery and how innovations in on-body injector technology may offer a practical path forwards.
STERILE DRUG PRODUCTION: AN EVER-EVOLVING MARKET
EXPERT VIEW
Norbert Kübler
STERILE DRUG PRODUCTION: AN EVER-EVOLVING MARKET
Dr Norbert Kübler discusses the current state of sterile drug products, considering how advancing technology is changing the field, the role of quality control and the challenges faced during scale-up and manufacturing.
MAINTAINING RELIABLE DRUG DELIVERY THROUGH SUSTAINABLE OPERATIONS
EXPERT VIEW
Henryk Badack
MAINTAINING RELIABLE DRUG DELIVERY THROUGH SUSTAINABLE OPERATIONS
Henryk Badack considers how a holistic approach to sustainability can enable CDMOs to implement efficient operations strategically – while introducing initiatives that address environmental, economic and social elements.
LATE-STAGE MATERIAL SUBSTITUTION: AMBITION FOR SUSTAINABILITY OR TRANSFER-TIME RISK?
EXPERT VIEW
Kiara Taylor
LATE-STAGE MATERIAL SUBSTITUTION: AMBITION FOR SUSTAINABILITY OR TRANSFER-TIME RISK?
Kiara Taylor delves into the challenges of changing materials to enhance sustainability after a design has been transferred to manufacturing, considering the reasons that might drive such a change, the issues involved and the benefits that can be gained.
SUSTAINABILITY IN DRUG DELIVERY
EXPERT VIEW
Adam Tilley
SUSTAINABILITY IN DRUG DELIVERY
Adam Tilley and David Cook explore how carbon footprint considerations can be integrated into the drug delivery device design lifecycle, highlighting key sustainability decisions faced by design engineers and emerging tools that support those evaluations.
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