ONdrugDelivery | Global Drug Delivery Industry Information & Intelligence

SUSTAINABILITY

BRINGING PHARMACEUTICAL ELASTOMER WASTE INTO A CIRCULAR ECONOMY

Yann Fromont and Clovis Saunier discuss Aptar Pharma and Moine Recyclage‘s partnership and explain how clean elastomer production scrap from the manufacture of injectable components is recovered and repurposed for durable technical applications.

NON-PTFE, NIA-PFAS POLYMERS FOR LIQUID DRUG DELIVERY DEVICES

Dr Erik Schwartz, Dirk van Oevelen and Anton Petrov discuss SABIC’s range of NIA-polyfluoroalkyl polymers and introduce the company’s fully functional autoinjector prototype, which uses the latest generation of resins and compounds from different polymer families.

A CALCULATED MOVE: PUTTING ENVIRONMENTAL ASSESSMENT DATA TO WIDER USE

Cristin Konkart and Shawn James investigate the importance of the underlying methodologies and expertise behind product carbon footprints and lifecycle assessments, drawing on Ypsomed’s accrued organisational expertise to demonstrate how these processes are evolving and providing greater value to the company and its partners.

WHY THE GREENEST POLYMERS NEVER REACHED SCALE

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.

MANUFACTURERS’ ROLE IN DELIVERING ESSENTIAL RESPIRATORY HEALTHCARE DURING THE TRANSITION TO LOW-GWP pMDIs

Darren Bromley-Davenport

Orbia Fluor & Energy Materials

MANUFACTURERS’ ROLE IN DELIVERING ESSENTIAL RESPIRATORY HEALTHCARE DURING THE TRANSITION TO LOW-GWP pMDIs

Darren Bromley-Davenport of Orbia Fluor & Energy Materials discusses the transition from current hydrofluoroalkane propellants to lower global warming potential alternatives for use in metered dose inhalers, highlighting the services that the company can offer the industry via its GMP facilities and wealth of experience to ensure that the transition is as smooth as possible.

DESIGNING WITH SUSTAINABILITY IN MIND: ENGINEERING LOW CARBON pMDIs FROM THE COMPONENT UP

DESIGNING WITH SUSTAINABILITY IN MIND: ENGINEERING LOW CARBON pMDIs FROM THE COMPONENT UP

Tony Mallett and Richard Turner explain the environmental strategies that shape inhalation device development and commercial manufacture when designing for propellants with low global warming potential, allowing patients to receive safe and effective treatment with lower environmental impact.

THE SUSTAINABILITY ESCAPE ROOM: HOW PRIMARY PACKAGING TRIES TO GET OUT OF THE EU REGULATORY MAZE

Dr Bettine Boltres

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.

THE OVERLOOKED SUSTAINABILITY LEVER: HUMAN FACTORS IN DRUG DELIVERY

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

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

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.

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.

BIOPLASTICS IN DRUG DELIVERY: SUSTAINABLE SOLUTION OR SUBSTITUTION TRAP?

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.

FOR THE RECORD: HOW PAST EXPERIENCE ENABLES FUTURE SUCCESS

PREFILLED SYRINGES

FOR THE RECORD: HOW PAST EXPERIENCE ENABLES FUTURE SUCCESS

Dr Jakob Lange and Shawn James 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.

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

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.

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.

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.

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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