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2025_Oct_Gerresheimer_leaderboard

PREFILLED SYRINGES

PREFILLED SYRINGES
ARE YOU STILL PIECING TOGETHER YOUR PREFILLABLE SYRINGE SYSTEM OR ARE YOU ALREADY FILLING IT?
Dr Bettine Boltres introduces the West Synchrony™ prefillable syringe system, explaining how the device, as a single comprehensive package, minimises regulatory complications and delays.
INJECTION
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.
TRENDS FOR 2026
EXPERT VIEW
Tom Oakley
TRENDS FOR 2026
A new reality is forming as we enter 2026 – it will not be “business as usual”. Geopolitical forces in the largest market for pharmaceuticals, the US, are likely to mean substantial changes. Here, Tom Oakley and Alex Vasiev cover those changes, the incretin juggernaut and the march of technical progress with “minitablet” dispensers, large-volume injectors and dual-chamber devices.
Interview: Enhancing Clinical Trials with CliniPilot<sup>®</sup> and Clear to Clinic™ Programme
INTERVIEW
Dr Carolina Canapè
Ypsomed
Interview: Enhancing Clinical Trials with CliniPilot® and Clear to Clinic™ Programme
Dr Carolina Canapè and Roger Lüscher talk with Guy Furness about the application of connectivity in decentralised trials, and how Ypsomed’s CliniPilot and the company’s range of clinic-ready autoinjectors support faster, more efficient and more effective clinical trials.
TIME TO MARKET: INCREASED CUSTOMER VALUE THROUGH GLOBAL RAMP-UP EXCELLENCE
PREFILLED SYRINGES
David Pircher
Baumann Medical
TIME TO MARKET: INCREASED CUSTOMER VALUE THROUGH GLOBAL RAMP-UP EXCELLENCE
David Pircher and Leander Moser discuss the advantages of having a global presence, which combines both local expertise and technical excellence with worldwide co-ordination of supply to deliver consistent and quality solutions.
EARLY AUTOMATION CONSIDERATIONS FOR THE DEVELOPMENT OF DRUG DELIVERY COMBINATION PRODUCTS
PREFILLED SYRINGES
Asmita Khanolkar
SMC Ltd
EARLY AUTOMATION CONSIDERATIONS FOR THE DEVELOPMENT OF DRUG DELIVERY COMBINATION PRODUCTS
Asmita Khanolkar and Al Neumann, uncover the manufacturing strategies that can be used to achieve design for automation, scale-up and sustainable solutions for clinical and commercial launch, describing the gains to be made in manufacturing efficiency when using small, automated work cells.
FRICTIONLESS ENGAGEMENT: HOW GX INMONIT™ CAN SIMPLIFY SELF-INJECTION AND STRENGTHENS PATIENT ADHERENCE
CONNECTIVITY
Giacomo Bruno
Gerresheimer
FRICTIONLESS ENGAGEMENT: HOW GX INMONIT™ CAN SIMPLIFY SELF-INJECTION AND STRENGTHENS PATIENT ADHERENCE
Dr Giacomo Bruno and Simon Buerdel consider the causes of patient non-adherence and its subsequent effects on healthcare systems, going on to present the solutions created by Gerresheimer to address the patient experience across treatment types.
TESTING AUTOINJECTORS ACCORDING TO ISO 11608-5 TO INCREASE RELIABILITY AND BOOST EFFICIENCY
PREFILLED SYRINGES
Wolfgang Moersch
ZwickRoell
TESTING AUTOINJECTORS ACCORDING TO ISO 11608-5 TO INCREASE RELIABILITY AND BOOST EFFICIENCY
Wolfgang Moersch discusses the role of automation in testing injection devices – including autoinjectors, pen injectors and on-body injectors – and how advanced testing software and robotics solutions can provide more accurate and consistent testing results.
SAFETY BY DESIGN FOR DRUG DELIVERY DEVICES
PREFILLED SYRINGES
Dr Stefan Schreiber
Scherdel Medtec
SAFETY BY DESIGN FOR DRUG DELIVERY DEVICES
Professor Stefan Schreiber, Dr Theo Wember and Sebastian Block discuss how using Design of Experiments methodology can provide insights into the manufacturing process of power springs that can enable manufacturers to more robustly control variables and produce more consistent outputs.
FROM CONCEPT TO SERIES PRODUCTION – ACCELERATING INDUSTRIALISATION IN MEDTECH
PREFILLED SYRINGES
Matthias Müller
Contexo
FROM CONCEPT TO SERIES PRODUCTION – ACCELERATING INDUSTRIALISATION IN MEDTECH
Matthias Müller and Sven Müller discuss Contexo and Probotec's combined approach to scaling drug-device combination products from laboratory prototypes to fully validated GMP commercial-scale production lines.
Interview: New But Not News – A Smooth Transition to USP <382> with Established Expertise
INTERVIEW
Dr Aurelie Rebuffet
BD (Becton Dickinson & Company)
Interview: New But Not News – A Smooth Transition to USP <382> with Established Expertise
Dr Aurélie Rebuffet and Virginie Jeymond, discuss the new requirements set out in the US Pharmacopeia (USP) Chapter <382>, including the shift towards assessing the drug-device combination product as a holistic whole and how ZebraSci and BD can support pharma companies in complying with USP <382>.
THE PLATFORM PARADOX: DEVICE DEVELOPMENT CHALLENGES WITHIN FAST EVOLVING DRUG DISCOVERY PIPELINES
EXPERT VIEW
Tim Quigg
THE PLATFORM PARADOX: DEVICE DEVELOPMENT CHALLENGES WITHIN FAST EVOLVING DRUG DISCOVERY PIPELINES
Tim Quigg, Mariam Al-Amari and Joel Gresham discuss how to enable high-dose delivery for novel biologics, using ex vivo and in silico approaches to accelerate drug-device development and improve device performance, thus de-risking projects and saving costs.
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.
EVOLVING ELASTOMER STOPPER TECHNOLOGIES FOR A CHANGING REGULATORY LANDSCAPE
CGT
Dr Laure-Helene Guillemot
Aptar Pharma
EVOLVING ELASTOMER STOPPER TECHNOLOGIES FOR A CHANGING REGULATORY LANDSCAPE
Dr Laure-Hélène Guillemot and Edouard Pagnoud assess the impact of the per- and polyfluoroalkyl substances ban on elastomer stoppers and the resulting extractables and leachables challenges, highlighting how Aptar Pharma is developing new solutions to meet both regulatory expectations and customer needs.
ENHANCING DRUG DELIVERY WITH INNOVATIVE SOFT MIST INHALER TECHNOLOGY
PULMONARY
Dr Nicolas Buchmann
Resyca
ENHANCING DRUG DELIVERY WITH INNOVATIVE SOFT MIST INHALER TECHNOLOGY
Dr Nicolas Buchmann and Bernhard Müllinger, discuss the capabilities of soft mist inhalers in terms of usability for patients, sustainability, compatibility with biologics and cost-effective delivery, showcasing these advantages in Resyca’s Pre-Filled Syringe Inhaler (PFSI).
ADOPTION OF SUSTAINABILITY PRACTICES WITHIN SUBCUTANEOUS DRUG DELIVERY: INDUSTRY INSIGHTS
PHARMA VIEW
Conor O'Neill
GSK
ADOPTION OF SUSTAINABILITY PRACTICES WITHIN SUBCUTANEOUS DRUG DELIVERY: INDUSTRY INSIGHTS
Conor O’Neill (GSK), Duncan Paterson (AstraZeneca) and Dr Monica Adams (GSK) come together to discuss a recent study conducted by the Subcutaneous Drug Development & Delivery Consortium among its member organisations, digging into the pharmaceutical industry’s progress and priorities when it comes to improving the environmental impact of subcutaneous medicines.
THE COMPASS FOR INNOVATION: REGULATORY AFFAIRS AT YPSOMED
INJECTION
Stefanie Stark
Ypsomed
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.
PROVING THE DESIGN SPACE: ADVANCING THE DEVELOPMENT OF SYRINGE-DEVICE COMBINATIONS
PREFILLED SYRINGES
Enrico Barichello
Stevanato Group
PROVING THE DESIGN SPACE: ADVANCING THE DEVELOPMENT OF SYRINGE-DEVICE COMBINATIONS
Enrico Barichello and Courtney Nicholas Sutton the innovative combination of the Molly® autoinjector with 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.
Interview: Steven Kaufman. Delivering the Future – Inside the World of Autoinjector Innovation
INTERVIEW
Steven Kaufman
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
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.
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.
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.
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