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INDUSTRIALISATION
INJECTION
DUAL CHAMBER
FORMULATION
PFS
WEARABLES
ALL INJECTION
OCULAR
ORAL
RESPIRATORY
PULMONARY
NASAL
ALL RESPIRATORY
MORE
INTERVIEWS
EXPERT VIEWS
EARLY INSIGHTS
COMPANY LISTINGS
OUR AUTHORS
THE MAGAZINE
EVENTS
ED CALENDAR
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INJECTION
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.
FORMULATION
Dr Liliana Miinea
Lubrizol
FROM BRICK-DUST DRUGS TO BREAKTHROUGHS: TRANSFORMING DRUG DELIVERY WITH NOVEL EXCIPIENTS
Dr Liliana Miinea of Lubrizol discusses how next-generation excipients can help formulators realise the potential of promising but poorly soluble drug candidates, including Lubrizol’s Apisolex™ and Apinovex™ polymer excipients for parenteral and oral applications.
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.
CGT
Krishnendu khan
West Pharmaceutical Services
PRIMARY PACKAGING AND ADMINISTRATION OF CELL THERAPIES: CURRENT TRENDS AND CHALLENGES
Dr Krishnendu Khan and Henry Nguyen of West Pharmaceutical Services examine factors to consider when designing and selecting primary packaging for cell therapies, exploring the effects of cryogenic storage on packaging and cells, while highlighting the diverse delivery methods and applications for these therapies.
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.
EXPERT VIEW
Dr Ethan Miller
SHEAR RELIEF: MINIMISING SHEAR STRESS IN CGT PRODUCTION
Dr Ethan Miller examines the manufacturing of cell and gene therapies where shear stress can impact cells and explores strategies to mitigate such damage, helping to ensure that therapies retain their viability, functionality and therapeutic potency from production through to administration.
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).
SUSTAINABILITY
Thuysi Dao
Ypsomed
CLOSING THE LOOP: DESIGNING THE FUTURE OF SUSTAINABLE DRUG DELIVERY DEVICES
Thuysi Dao outlines a two-pronged approach to improving the sustainability profile of drug delivery devices, combining sustainable device design with real-world take-back and recycling initiatives, and explores how Ypsomed’s new YpsoLoop autoinjector platform embodies this vision.
INTERVIEW
Fabien de Coninck
Aptar Pharma
Interview: A Structured Approach to the Eco-Design Process
Fabien De Coninck and Bruno Morchain discuss Aptar Pharma’s eco-design philosophy with ONdrugDelivery’s Guy Furness. They cover how Aptar Pharma has implemented lifecycle assessments as a key tool to elucidate the environmental footprint of the company’s rubber components for primary packaging for injectable systems, including how they tackled the unique challenges presented by the complex, proprietary formulations involved in elastomer component design.
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.
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.
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.
EXPERT VIEW
Dr Alex Vasiev
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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