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INJECTION

ALTERNATIVE APPROACH FOR DEVICE SUBSTITUTABILITY: HUMAN FACTORS STUDIES FOR GENERICS & BIOSIMILARS
PHARMA VIEW
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
BBS Automation
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 Group
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
Chelsea Keeton
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
Contexo
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
Twan Mertens
IGS GeboJagema
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
SCHOTT Pharma
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
David Pircher
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
Iker Ibisate
RPK Medical
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
INJECTION
Bernd Zeiss
Gerresheimer
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
SUSTAINABILITY
Tim Holden
Owen Mumford
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.
A NOVEL FORCE-MODELLING METHOD & SOFTWARE FOR ACCELERATING TIME TO MARKET FOR NEW INJECTION DEVICES
PREFILLED SYRINGES
Bradley Sawyer
Sanner Group
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.
ADVANCEMENTS IN INTRADERMAL DELIVERY: FROM HISTORIC TECHNIQUES TO MODERN INNOVATIONS
INJECTION
Michele Guasti
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
INJECTION
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
INJECTION
Asmita Khanolkar
SMC Ltd
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
VIDEO
Lifecore Injectables
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
INTERVIEW
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
Contexo
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
DUAL CHAMBER
Marc Flippe
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
DUAL CHAMBER
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
DUAL CHAMBER
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.
ADVANCING LYOPHILISED DRUG DELIVERY WITH REUNITE™: RECONSTITUTION MADE SIMPLE
DUAL CHAMBER
Dr Nina Fetz
SHL Medical
ADVANCING LYOPHILISED DRUG DELIVERY WITH REUNITE™: RECONSTITUTION MADE SIMPLE
Dr Nina Fetz introduces SHL Medical's Reunite®, the first and only commercialised dual-chamber cartridge, three-step autoinjector featuring the company’s Needle Isolation Technology. With automated reconstitution, Reunite enables reliable self-injection of lyophilised formulations, supporting home-based care models.
BEYOND THE BARREL: A DUAL-CARTRIDGE IMPROVEMENT TO TRADITIONAL DUAL-CHAMBER DEVICES
DUAL CHAMBER
Dr Brent Buchine
Windgap Medical
BEYOND THE BARREL: A DUAL-CARTRIDGE IMPROVEMENT TO TRADITIONAL DUAL-CHAMBER DEVICES
Dr Brent Buchine explores how Windgap Medical’s devices transform dual-chamber systems with a modular, scalable and remarkably simple approach to reconstitution and complex drug delivery.
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