ONdrugDelivery | Global Drug Delivery Industry Information & Intelligence

INJECTION

FOR THE RECORD: HOW PAST EXPERIENCE ENABLES FUTURE SUCCESS

Dr Jakob Lange and Shawn James of Ypsomed discuss the value of the experience hidden behind metrics such as completed projects and commercialised devices – the wealth of accumulated process knowledge that enables a company to bring hard-learned lessons forwards to benefit each new development programme and evolve its product portfolio to meet the needs of an evolving sector.

PREFILLED SYRINGES

THE PLATFORM ADOPTION GAP: WHY DEVICE SELECTION IS ONLY THE BEGINNING OF COMBINATION PRODUCT DEVELOPMENT

Darren Hieber investigates the often overlooked gap between selecting an injection device platform for a drug development programme and having a finalised combination product ready for commercialisation, digging into the various activities required to bridge the gap.

When More Matters – Advancing Large-Volume Drug Delivery with SHL’s Magnitude

In this interview, Vince Masciopinto, discusses the strategic evolution of SHL's Maggie platform into Magnitude while discussing large-volume delivery and considering the technical breakthroughs, market shifts and user insights that define its growth.

Ensuring Deep-Cold Reliability for mRNA Therapies: Advancing CCI Testing Approaches for Prefilled Syringes

PREFILLED SYRINGES

Dr Nesrine Rebzani

BD (Becton Dickinson & Company)

Ensuring Deep-Cold Reliability for mRNA Therapies: Advancing CCI Testing Approaches for Prefilled Syringes

Dr Nesrine Rebzani and Elsa Muller of BD discuss recent work done by the company to establish a robust methodology for testing the container closure integrity of prefillable syringes under deep-cold conditions, highlighting the challenges in establishing these methods and the value of the data acquired.

BREAKTHROUGH FOR LARGE-VOLUME MANUAL INJECTION: A FIRST-OF-ITS-KIND LARGE-VOLUME PFS IN A PASSIVE SAFETY SYSTEM

PREFILLED SYRINGES

Isabelle Jeangoudoux

BREAKTHROUGH FOR LARGE-VOLUME MANUAL INJECTION: A FIRST-OF-ITS-KIND LARGE-VOLUME PFS IN A PASSIVE SAFETY SYSTEM

Isabelle Jeangoudoux and Léa Salfati introduce the industry’s first fully integrated large-volume passive safety system, combining the syriQ BioPure^® 5.5 mL prefillable glass syringe with the Safe'n'Sound^® 5.5 mL passive safety system. The authors explain how joint development, compatibility testing and human factors research are de-risking large-volume subcutaneous self-injection at home.

IMPLANTABLE DRUG DELIVERY SYSTEMS: BUILDING A ROBUST SUPPLY CHAIN FROM POLYMER EXTRUDATE TO COMMERCIAL PRODUCT

INDUSTRIALISATION

IMPLANTABLE DRUG DELIVERY SYSTEMS: BUILDING A ROBUST SUPPLY CHAIN FROM POLYMER EXTRUDATE TO COMMERCIAL PRODUCT

Ingmar Kneer discusses the broader considerations of commercialising an implantable drug delivery system beyond the implant itself, considering factors such as manufacturing, automation, regulatory concerns, traceability and the accompanying delivery system.

FROM COMPONENT TESTING TO SYSTEM PERFORMANCE: THE SHIFT IN VERIFYING MODERN DRUG DELIVERY SYSTEMS

FROM COMPONENT TESTING TO SYSTEM PERFORMANCE: THE SHIFT IN VERIFYING MODERN DRUG DELIVERY SYSTEMS

Erik Berndt and Peter Schmidt consider the relationship between ISO and USP requirements for the effective verification of modern drug delivery systems, providing an overview linking relevant chapters of the US Pharmacopeia to the corresponding ISO-based test requirements.

A Large-Volume and High-Viscosity Autoinjector Delivery Platform for Biotherapeutics

Asmita Khanolkar

A Large-Volume and High-Viscosity Autoinjector Delivery Platform for Biotherapeutics

Asmita Khanolkar, Marta Vilaplana, Susanna White and Pete Evans present the Bios platform, designed to simplify device development for the delivery of biologics while maintaining identical key design aspects across all Bios variants.

QUANTIFYING THE PHYSICAL CAPABILITIES OF FEMALE AUTOINJECTOR USERS

Dr Niels Christian Nilsson

Crux Product Design

QUANTIFYING THE PHYSICAL CAPABILITIES OF FEMALE AUTOINJECTOR USERS

Dr Niels Christian Nilsson, Dr Horacio Pace-Bedetti, James Hoare and Matt Hill, summarise a recent empirical study characterising the physical strength of female autoinjector users, which can be used as a basis for design specifications and help to ensure more accessible shield-activated autoinjectors.¹

Building a Biopharmaceutical-Grade PFS: From Glass Tubing to Finished Container

PREFILLED SYRINGES

Charlotte Leconte-Ostrowski

NIPRO PharmaPackaging

Building a Biopharmaceutical-Grade PFS: From Glass Tubing to Finished Container

Charlotte Leconte-Ostrowski and Christoph Grinda present ENOVIA™, a quality level designed to enhance understanding and achievement of high quality device design for combination products, biologics and biosimilars.

FROM 3 mL TO 5 mL: EXTENDING AN AUTOINJECTOR PLATFORM FOR LARGER-VOLUME BIOLOGICS

FROM 3 mL TO 5 mL: EXTENDING AN AUTOINJECTOR PLATFORM FOR LARGER-VOLUME BIOLOGICS

Moritz Mond and Dr Reza Abedian consider the subcutaneous delivery of larger volumes and higher viscosities, sharing the innovative engineering behind the Gx Inbeneo 5 mL autoinjector concept, designed to offer future developers greater flexibility for drug delivery via a handheld device.

ENGINEERING THE NEXT GENERATION OF AUTOINJECTORS

ENGINEERING THE NEXT GENERATION OF AUTOINJECTORS

Iker Ibisate examines the significant potential of springs and stamped metal components to broaden the design space for autoinjector platform developers by condensing an increasing array of key functions into a minimal number of high-precision parts.

THE RISE OF SILICONE-FREE PREFILLED SYRINGES: NEW FUNCTIONAL TESTING CONSIDERATIONS

PREFILLED SYRINGES

Landon Goldfarb

THE RISE OF SILICONE-FREE PREFILLED SYRINGES: NEW FUNCTIONAL TESTING CONSIDERATIONS

Landon Goldfarb considers the impact that new alternative and silicone-free coating technologies, developed in response to the challenges presented by the interaction of silicone with sensitive novel biologics, are having on the syringe landscape and how device developers and pharmaceutical companies can ensure the compatibility of these new syringe formats with modern therapeutics and autoinjector systems.

PRIME NEXUS: Advancing the Autoinjector with the Power of Software

Dr Patrick Anquetil

Portal Instruments

PRIME NEXUS: Advancing the Autoinjector with the Power of Software

In this exclusive interview, Dr Patrick Anquetil sits down with Guy Furness to talk about how Portal and the drug delivery industry have changed since the company was first founded over a decade ago and the significant unmet need in injectable drug delivery around the 5–10 mL volume range. Dr Anquetil explains how Portal’s electromechanical PRIME NEXUS platform uses software to solve challenges in this space that springs simply cannot, and how devices such as PRIME NEXUS are set to meet the expectations of the future.

SYNCHRONISED AND OPTIMISED: FOLLOWING THE PATH OF INTEGRATION TO SIMPLIFY SELF-INJECTION DEVICE DEVELOPMENT

PREFILLED SYRINGES

West Pharmaceutical Services

SYNCHRONISED AND OPTIMISED: FOLLOWING THE PATH OF INTEGRATION TO SIMPLIFY SELF-INJECTION DEVICE DEVELOPMENT

Maria Barajas and Katie Falcone introduce the West Synchrony™ S1 prefillable syringe system and explain how streamlining the design, regulatory and manufacturing processes through an innovative platform that uniquely integrates the syringe barrel, plunger and needle shield/tip cap into a fully harmonised, verified system from a single supplier can improve patient adherence and quality of life.

FROM FRAGMENTED PROCUREMENT TO INTEGRATED ASSEMBLY: HOW THE INJECTABLE DEVICE INDUSTRY IS RETHINKING EQUIPMENT STRATEGY

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

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.

The Effect of Freeze-Thaw Cycles on the Euroject<sup>®</sup> System

PREFILLED SYRINGES

Pauline Genovese

Unither Pharmaceuticals

The Effect of Freeze-Thaw Cycles on the Euroject^® System

Pauline Genovese, Laury Livemont and Dr Alexandre Fontayne, present the findings of nine studies that investigated the impact of freezing and thawing on the company’s Euroject^® injection system and its ability to deliver the appropriate dose.

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.

Building Confidence in Combination Product Development Through Pre-Verified Syringe-Device Configurations

PREFILLED SYRINGES

Stevanato Group

Building Confidence in Combination Product Development Through Pre-Verified Syringe-Device Configurations

Chiara Carraro and Enrico Barichello explain how pre-verified autoinjector and prefilled syringe configurations can help pharmaceutical companies make faster, evidence-based decisions when developing combination products for complex injectable therapies.

Interview: Contamination Control in Practice: BD’s Global, Risk-Based Approach to Supporting Sterile Drug Manufacturing

Patrick Jeukenne

BD (Becton Dickinson & Company)

Interview: Contamination Control in Practice: BD’s Global, Risk-Based Approach to Supporting Sterile Drug Manufacturing

BD's Patrick Jeukenne and Frédérique Pedretti-Abel explain how the company is putting contamination control into practice through global strategy, concrete investments and measurable actions. This approach is designed to support pharmaceutical manufacturers’ compliance and operational performance, while ultimately contributing to the quality and safety of medicines delivered to patients.

GETTING OUT OF A JAM: SUSPENSION DELIVERY, OCCLUSION AND DEVICE DESIGN

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.

Drug Delivery Devices Past and Future: A Retrospective on Innovation, Achievement and Hard Lessons

Drug Delivery Devices Past and Future: A Retrospective on Innovation, Achievement and Hard Lessons

Tom Oakley and Ulrich Bruggemann discuss the innovations that featured novel forms of drug delivery for patients, but either failed to succeed commercially or even reach the market.

MASTERING PRODUCT TRANSFER FOR A RANGE OF INJECTABLES

Lifecore Injectables

MASTERING PRODUCT TRANSFER FOR A RANGE OF INJECTABLES

Lifecore Injectables explores product transfer, the often overlooked step between formulation and filling, and looks at how transfer technologies, mixing and recirculation strategies can be matched to the demands of water-like solutions, highly viscous products and fast-settling suspensions to maintain product quality throughout manufacturing.

Interview: Eco-Inject: Bringing Affordable Sustainability to Single-Use Disposable Autoinjectors

Interview: Eco-Inject: Bringing Affordable Sustainability to Single-Use Disposable Autoinjectors

In this exclusive interview, Michael Earl and Steven Kaufman speak about the significant progress Eco-Inject has made throughout 2026 since its highly successful funding round earlier in the year, discussing what’s new in the world of Eco-Inject, what sets the device platform apart from other approaches to sustainability in the autoinjector space, and how the industry is reacting to Eco-Inject as it moves towards the market.

END-OF-DOSE CLICK-BAIT: HARDER THAN IT SOUNDS

Peter McGrattan

Team Consulting

END-OF-DOSE CLICK-BAIT: HARDER THAN IT SOUNDS

Peter McGrattan focuses in on the particular challenge of engineering an end-of-dose click for autoinjectors, examining the key design tensions, increasing regulatory attention, the trade-offs between different power mechanisms and how potential alternative feedback mechanisms may play into the design.

USP <382> SYSTEM-LEVEL INSIGHTS TO SUPPORT EARLIER PACKAGING DECISIONS

PREFILLED SYRINGES

Pavan Hemmege Venkatappa

USP <382> SYSTEM-LEVEL INSIGHTS TO SUPPORT EARLIER PACKAGING DECISIONS

Drawing on Aptar Pharma’s system-level collaboration framework, Pavan Hemmege Venkatappa, Technical Product Manager, explains how testing aligned with USP <382> can generate insights that support earlier decisions in packaging and delivery system development and can help development teams better understand system behaviour, identify potential risk areas and guide packaging system decisions before formal validation begins.

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