ONdrugDelivery | Global Drug Delivery Industry Information & Intelligence

INJECTION

PROVING THE DESIGN SPACE: ADVANCING THE DEVELOPMENT OF SYRINGE-DEVICE COMBINATIONS

Enrico Barichello and Courtney Nicholas Sutton describe the innovative combination of SHL's Molly^® autoinjector with Stevanato's Alba^® and Nexa^® prefilled syringes, which addresses the need to streamline device approval by establishing comprehensive compatibility testing, collaboration between suppliers and validated solutions for drug delivery.

THE COMPASS FOR INNOVATION: REGULATORY AFFAIRS AT YPSOMED

Stefanie Stark and Sandra Schaerer-Lickova highlight how regulatory strategy enables ideas to become solutions, supports development through the product lifecycle and helps ensure that patients worldwide obtain safe and timely access.

PREFILLED SYRINGES

A NOVEL FORCE-MODELLING METHOD & SOFTWARE FOR ACCELERATING TIME TO MARKET FOR NEW INJECTION DEVICES

Bradley Sawyer, Elena Guss Tarazona, Matthew Latham, Charlie Bowen, Dr Jay Sayed, and Harriet Field describe new software co-developed by Sanner Group and Pfizer to translate syringe test data into injection device performance, and to work backwards from device performance after shelf-life expiration to the maximum forces they can allow in a syringe test.

USING OXYCAPT™ MULTILAYER PLASTIC VIAL FOR GENE AND CELL THERAPIES STORED IN DRY ICE AND LIQUID NITROGEN

PREFILLED SYRINGES

Hiroki Hasegawa

Mitsubishi Gas Chemical

USING OXYCAPT™ MULTILAYER PLASTIC VIAL FOR GENE AND CELL THERAPIES STORED IN DRY ICE AND LIQUID NITROGEN

Hiroki Hasegawa and Tomohiro Suzuki consider the various challenges presented by cold-chain logistics to both traditional glass vials and many cyclo-olefin polymer alternatives, and how Mitsubishi Gas Chemical's OXYCAPT™ vials offer significant advantages for maintaining container closure integrity compared with other materials on the market.

AUTOINJECTORS VERSUS ON-BODY SYSTEMS: THE FUTURE OF LARGE-VOLUME DELIVERY

AUTOINJECTORS VERSUS ON-BODY SYSTEMS: THE FUTURE OF LARGE-VOLUME DELIVERY

Dr Alex Vasiev and Dr Ethan Miller weigh up the benefits and costs of using on-body injectors versus autoinjectors, discussing delivery, design and patient population variability alongside recent advances in on-body injector development.

Interview: Steven Kaufman. Delivering the Future – Inside the World of Autoinjector Innovation

Portal Instruments

Interview: Steven Kaufman. Delivering the Future – Inside the World of Autoinjector Innovation

Steven Kaufman talks with ONdrugDelivery’s Guy Furness about the world of autoinjectors, looking at the current status quo in the industry, using Portal’s PRIME Nexus™ smart reusable electromechanical autoinjector as a lens to bring into focus how things have changed and where they might be going.

ALTERNATIVE APPROACH FOR DEVICE SUBSTITUTABILITY: HUMAN FACTORS STUDIES FOR GENERICS & BIOSIMILARS

Carrie O’Donel

Teva Pharmaceuticals

ALTERNATIVE APPROACH FOR DEVICE SUBSTITUTABILITY: HUMAN FACTORS STUDIES FOR GENERICS & BIOSIMILARS

Carrie O’Donel, Henri Akouka, Mark DeStefano along with Leslie Sanchez-Torres, discuss the shortcomings of current comparative use approaches to determining substitutability of devices for generics and biosimilars and propose an alternative approach to human factors studies based on long-standing methodologies that has the potential to unlock innovation and improve the user experience for patients.

INFLUENCE OF MACHINE CONCEPTS ON OVERALL EQUIPMENT EFFECTIVENESS

INDUSTRIALISATION

Dr Carsten Köhler

INFLUENCE OF MACHINE CONCEPTS ON OVERALL EQUIPMENT EFFECTIVENESS

Carsten Köhler provides an overview of the key metrics that contribute to overall equipment effectiveness for manufacturing drug delivery devices, detailing some of the options available when considering large-scale, high-volume manufacture.

NOLATO’S VIRTUAL FACTORY IN ACTION: ACCELERATING DRUG DELIVERY INNOVATION

INDUSTRIALISATION

Patrik Ingvarsson

NOLATO’S VIRTUAL FACTORY IN ACTION: ACCELERATING DRUG DELIVERY INNOVATION

Patrik Ingvarsson discusses Nolato’s virtual factory methodology, wherein embedded technical experts help drug delivery device developers reduce risk, costs and time to market through intelligent application of simulations to facilitate smoother and more robust development cycles with fewer iterations required.

FROM CARTRIDGE TO COMMERCIALISATION – UNDERSTANDING THE FILL-FINISH PROCESS

PREFILLED SYRINGES

Grand River Aseptic Manufacturing

FROM CARTRIDGE TO COMMERCIALISATION – UNDERSTANDING THE FILL-FINISH PROCESS

Chelsea Keeton digs into the challenging yet often overlooked process of fill-finish, discussing the particular hurdles and considerations that come with filling drug products into primary containers, with an emphasis on cartridges and their role in an injectables landscape increasingly influenced by the needs of biologics.

HIGH-SPEED ASSEMBLY OF NEEDLE SHIELDS FOR PREFILLED SYRINGES

INDUSTRIALISATION

Matthias Müller

HIGH-SPEED ASSEMBLY OF NEEDLE SHIELDS FOR PREFILLED SYRINGES

Matthias Müller discusses the factors that set exceptional manufacturing equipment apart from the rest and how Contexo's new machine for assembling needle shields with prefilled syringes meets all these expectations.

INSIDE A TRACK-AND-TRACE SYSTEM FOR MEDICAL MOULDS: A MODEL FOR HEALTHCARE MANUFACTURING

INDUSTRIALISATION

INSIDE A TRACK-AND-TRACE SYSTEM FOR MEDICAL MOULDS: A MODEL FOR HEALTHCARE MANUFACTURING

Twan Mertens and Floor Verhorst-Willems explore how IGS GeboJagema provides comprehensive visibility into every aspect of its operations with a 100% control track-and-trace process, spanning from initial sales discussions through to final validation and beyond.

LAUNCHING A LARGE-VOLUME PREFILLABLE GLASS SYRINGE SYSTEM: RELIABLE SUBCUTANEOUS DRUG DELIVERY

PREFILLED SYRINGES

Isabelle Jeangoudoux

LAUNCHING A LARGE-VOLUME PREFILLABLE GLASS SYRINGE SYSTEM: RELIABLE SUBCUTANEOUS DRUG DELIVERY

Isabelle Jeangoudoux and Sven Pohle introduce SCHOTT Pharma’s new syriQ BioPure 5.5 mL staked-needle prefillable glass syringe and explain how this solution meets the growing need for large-volume subcutaneous drug delivery.

ENSURING EXCELLENCE IN MANUFACTURING

PREFILLED SYRINGES

Baumann Medical

ENSURING EXCELLENCE IN MANUFACTURING

David Pircher, Pavel Zahradník and Maxime Ludwig discuss the medical mindset in the context of quality and present examples and tools that are used in practice.

HOW COC SYRINGES ARE SHAPING THE FUTURE OF INJECTABLE DRUG DELIVERY

PREFILLED SYRINGES

Tom Van Ginneken

Wirthwein Medical

HOW COC SYRINGES ARE SHAPING THE FUTURE OF INJECTABLE DRUG DELIVERY

Tom Van Ginneken explores the advantages of cyclo-olefin copolymer syringes, including where they outperform glass, which applications benefit most and why many common objections are outdated or debunked by current data, market adoption and technological advances.

CUSTOM METAL SOLUTIONS FOR EMERGING CHALLENGES IN AUTOINJECTOR SYSTEMS

PREFILLED SYRINGES

CUSTOM METAL SOLUTIONS FOR EMERGING CHALLENGES IN AUTOINJECTOR SYSTEMS

Iker Ibisate, Álvaro García Nograro and Irakusne Incierte, address the complex manufacturing challenges posed by increasingly sophisticated autoinjector devices and introduce RPK Medical’s approach as a technical partner in overcoming these challenges through the tailored design and manufacture of functional metal components, such as precision springs and stamped parts.

MORE THAN THE SUM OF ITS PARTS: HOW SUPPLIER COLLABORATION DRIVES SUCCESSFUL COMBINATION PRODUCTS

MORE THAN THE SUM OF ITS PARTS: HOW SUPPLIER COLLABORATION DRIVES SUCCESSFUL COMBINATION PRODUCTS

Bernd Zeiss, Lucy Lee and Sébastien Cordier discuss the multitudinous advantages of collaboration between suppliers and pharma partners, from boosting innovation to optimising component choices for device development early on, all while ensuring compliance with global regulatory standards.

SMARTER FOR BUDGETS & KINDER TO THE PLANET: ECOSAFE<sup>®</sup> SAFETY SYRINGE PLATFORM

SMARTER FOR BUDGETS & KINDER TO THE PLANET: ECOSAFE^® SAFETY SYRINGE PLATFORM

Tim Holden describes the key objectives behind Owen Mumford’s 1 mL safety syringe injection platform and how the company sought to provide a single platform for all patients (able, less dexterous and needle-phobic) while minimising cost, waste and carbon footprint impact.

ADVANCEMENTS IN INTRADERMAL DELIVERY: FROM HISTORIC TECHNIQUES TO MODERN INNOVATIONS

Terumo Medical Care Solutions

ADVANCEMENTS IN INTRADERMAL DELIVERY: FROM HISTORIC TECHNIQUES TO MODERN INNOVATIONS

Michele Guasti explores the evolution of intradermal delivery methods, comparing historic methods of delivery, such as the Mantoux technique, with modern innovations, such as the Terumo Immucise™ intradermal injection system. The article goes on to discuss the expanding applications of intradermal delivery, including its potential for targeted lymph node delivery.

WHY YOU CANNOT DESIGN A PREFILLED SYRINGE SYSTEM OUT OF COMPONENTS

Dr Bettine Boltres

West Pharmaceutical Services

WHY YOU CANNOT DESIGN A PREFILLED SYRINGE SYSTEM OUT OF COMPONENTS

Dr Bettine Boltres unravels the complexities of bringing a new molecule to market as part of a combination product and rethinks the way that drug-device design could be tackled instead, approaching the system as a whole rather than through individual component development.

A CONFIGURABLE PATIENT-CENTRIC DELIVERY PLATFORM FOR BIOLOGICS AND HIGH CONCENTRATION FORMULATIONS

Asmita Khanolkar

A CONFIGURABLE PATIENT-CENTRIC DELIVERY PLATFORM FOR BIOLOGICS AND HIGH CONCENTRATION FORMULATIONS

Asmita Khanolkar and Marta Vilaplana, explore key challenges in delivering complex biologics and formulations, as well as the importance of early device involvement in preclinical development. They go on to consider how configurable platform technologies can support delivery of biologics, suspensions and high-viscosity formulations.

A HOME for Your Molecule – Lifecore Biomedical

Lifecore Biomedical

A HOME for Your Molecule – Lifecore Biomedical

More than a parenteral CDMO, your discovery deserves a home. A home where the level of care is unmatched. Learn why Lifecore Biomedical is the right home for your molecule.

Interview: Making Dual-Chamber Systems a Viable Alternative

Laxman Halleppanavar

Credence MedSystems

Interview: Making Dual-Chamber Systems a Viable Alternative

In this exclusive interview, Laxman Halleppanavar and Guy Furness discuss industry trends and challenges with injectable delivery, and how Credence MedSystems' dual-chamber devices provide solutions to address those challenges. Mr Halleppanavar goes into details of Credence’s role in this increasingly important sector of the drug delivery market, explaining the company’s approach to device design, development and overcoming the barriers posed by supply chain management.

HIGH SPEED LASER ASSEMBLY – FLEXIBLE MACHINE CONCEPTS WITH FULL LASER INTEGRATION

INDUSTRIALISATION

Matthias Müller

HIGH SPEED LASER ASSEMBLY – FLEXIBLE MACHINE CONCEPTS WITH FULL LASER INTEGRATION

Matthias Müller discusses the advantages of including laser technology in drug delivery device manufacturing, covering the various ways in which this technology can be applied and used to provide efficient, cost-effective and clean processes at high throughput rates.

DE-RISKING A NOVEL VALVE COMPONENT FOR USE WITH STANDARD SYRINGE AND AUTOINJECTOR PLATFORMS

BD (Becton Dickinson & Company)

DE-RISKING A NOVEL VALVE COMPONENT FOR USE WITH STANDARD SYRINGE AND AUTOINJECTOR PLATFORMS

Marc Flippe and Sophie Lelias introduce a novel valve component designed to enable dual-chamber functionality within standard syringe and autoinjector platforms. Developed through a comprehensive modelling and development framework, the BD dual-injection syringe system provides a scalable solution to dual-chamber injection that reduces the burden of change by preserving compatibility with established container formats and device architectures.

IMPROVING THE SELF-ADMINISTRATION OF LYO- AND LIQUID-LIQUID FORMULATIONS

Bjørn Knud Andersen

Phillips Medisize

IMPROVING THE SELF-ADMINISTRATION OF LYO- AND LIQUID-LIQUID FORMULATIONS

Bjørn Andersen and Iain Simpson explore the factors contributing to interest in lyo-liquid and liquid-liquid drug delivery, highlighting some of the current unmet needs in this space. Following this, they discuss how platform technologies, such as electromechanical drives, may help address these unmet needs.

TWO INTO ONE: SOLVING COMPLEX DRUG DELIVERY PROBLEMS WITH DUAL-CHAMBER CONTAINMENT SOLUTIONS

Enrico Barichello

Stevanato Group

TWO INTO ONE: SOLVING COMPLEX DRUG DELIVERY PROBLEMS WITH DUAL-CHAMBER CONTAINMENT SOLUTIONS

Enrico Barichello and Valerio Ravazzolo describe how dual-chamber solutions ensure isolation, integrity and safety for managing lyophilised and liquid drugs. With innovative and customisable designs, these technologies improve drug delivery, reduce contamination risks and simplify complex therapies, addressing the evolving needs of both pharmaceutical industry and patients.

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