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PREFILLED SYRINGES

INTERVIEW WITH STEPHEN M PERRY AND NICHOLAS CICCARELLI
INTERVIEW
Stephen Perry
INTERVIEW WITH STEPHEN M PERRY AND NICHOLAS CICCARELLI
Stephen Perry and Nicholas Ciccarelli discuss the August 2021 acquisition of Neuma by Kymanox, highlighting how the acquisition has positioned Kymanox to lead the development of particularly complex drug delivery systems and cutting-edge medical device technologies, providing additional services to progress combination products to market.
PHOTOSTABILITY TESTS OF ANTIBODY DRUGS
PREFILLED SYRINGES
Yoshiko Sakuma
PHOTOSTABILITY TESTS OF ANTIBODY DRUGS
Yoshiko Sakuma and Tomohiro Suzuki provide an overview of Mitsubishi Gas Chemical's OXYCAPT multilayer vial and syringe, with a particular focus on the recent investigations into the interaction of OXYCAPT’s UV barrier with the photostability of antibody drugs, compared with standard cyclo-olefin polymer and Type 1 glass.
DEVELOPING A FULLY AUTOMATED MODULAR MACHINE PLATFORM FOR AUTOINJECTOR TESTING
INDUSTRIALISATION
Lucy Chung
DEVELOPING A FULLY AUTOMATED MODULAR MACHINE PLATFORM FOR AUTOINJECTOR TESTING
Lucy Chung and Gilbert Fluetsch discuss the benefits of a modular automated test platform.
THE FUTURE OF CONTAINER-LEVEL TRACEABILITY FOR PREFILLABLE SYRINGES
INDUSTRIALISATION
Sam Eubanks
THE FUTURE OF CONTAINER-LEVEL TRACEABILITY FOR PREFILLABLE SYRINGES
Sam Eubanks and Hervé Soukiassian discuss the BD traceability solution. This concept under development aims to deliver traceability at the unique container level from manufacture to the point of care.
HOW DIGITISATION IS DELIVERING COMPETITIVE ADVANTAGE IN DEVICE ASSEMBLY
INDUSTRIALISATION
Jens Schou Christensen
HOW DIGITISATION IS DELIVERING COMPETITIVE ADVANTAGE IN DEVICE ASSEMBLY
Jens Schou Christensen and Sebastian Berninger-Lund present the business case for the wider implementation of digitisation and the greater use of data to deliver assembly line improvements.
PUTTING POST-PANDEMIC SUPPLY CHAINS TO THE TEST
INDUSTRIALISATION
John Swift
PUTTING POST-PANDEMIC SUPPLY CHAINS TO THE TEST
John Swift discusses the need for medtech companies to undertake a reappraisal of their supply chains in light of covid-19, taking into consideration how the pandemic has exposed vulnerabilities that have previously gone unnoticed or ignored.
UPDATE ON OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE
INDUSTRIALISATION
Hiroki Hasegawa
UPDATE ON OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE
Hiroki Hasegawa and Tomohiro Suzuki discuss the advantages of OXYCAPT™ multilayer plastic vial and syringe, which combine the benefits of cyclo-olefin polymer with excellent oxygen and UV barrier properties. In particular, the authors focus on recent studies that highlight OXYCAPT’s very low levels of extractables.
PATENTS ARE IMPORTANT FOR SMART HEALTHCARE PRODUCTS
CONNECTIVITY
Napoleon Monroe
PATENTS ARE IMPORTANT FOR SMART HEALTHCARE PRODUCTS
Napoleon Monroe discusses the value of internet-connected smart devices in present-day healthcare, and introduces the mMed patent portfolio, of which Mr Monroe is the sole inventor, and which contains five US patents for key connected health technologies.
FROM PROCESS TO PRODUCT: OPTIMISING PROCESS DEVELOPMENT STRATEGIES FOR VARIABLE DRUG-DEVICE REQUIREMENTS
INJECTION
Markus Goldinger
FROM PROCESS TO PRODUCT: OPTIMISING PROCESS DEVELOPMENT STRATEGIES FOR VARIABLE DRUG-DEVICE REQUIREMENTS
Markus Goldinger and Erik Alexandersson discuss the benefits to process development provided by SHL’s fully in-house, vertically integrated model, and how those benefits are applied throughout the process from initial design work to final assembly of the drug delivery device and primary container.
TOWARDS USER-CENTRIC SPECIFICATION OF AUTOINJECTOR TECHNICAL ATTRIBUTES: INSIGHTS FROM EMPIRICAL WORK
INJECTION
Andreas Schneider
TOWARDS USER-CENTRIC SPECIFICATION OF AUTOINJECTOR TECHNICAL ATTRIBUTES: INSIGHTS FROM EMPIRICAL WORK
Andreas Schneider discusses an empirical study into both users’ ability to remove the cap from an autoinjector and the difficulty those patients perceived in doing so. The study builds a quantitative model relating the empirical data to patient perception.
HOW TO ENSURE THE FUTURE DEMAND FOR BIOLOGICS CAN STILL BE DELIVERED BY INJECTABLES
INJECTION
Anthony Vico
HOW TO ENSURE THE FUTURE DEMAND FOR BIOLOGICS CAN STILL BE DELIVERED BY INJECTABLES
Anthony Vico and Enrico Barichello discuss the demands that high-viscosity biologic formulations place on prefilled syringes, and how pharmaceutical companies can make the most of this growing market segment to deliver improved quality of life for patients.
FORMULATION & DEVICE DEVELOPMENT: A SYMBIOTIC RELATIONSHIP
FORMULATION
Caroline Zakrzewski
FORMULATION & DEVICE DEVELOPMENT: A SYMBIOTIC RELATIONSHIP
Caroline Zakrzewski considers the interaction between formulation and device development and the challenges that drive innovation in the field. Her work frequently sits in the overlap between formulation and device development, navigating the interwoven steps that lead to the sweet spot, where formulation and a device work in tandem, providing safe and effective delivery of the drug.
RE-USABLE ELECTRONIC AUTOINJECTOR – FLEXIBLE PERFORMANCE
CONNECTIVITY
Bjarne Sørensen
RE-USABLE ELECTRONIC AUTOINJECTOR – FLEXIBLE PERFORMANCE
Bjarne Sørensen discusses the ability of electronically driven injection devices to cater for a broad range of liquid drug properties within a single device platform.
OPHTHALMIC DRUGS: PATHWAY TO OVERCOME PRIMARY PACKAGING AND DRUG PRODUCT MANUFACTURING CHALLENGES
OCULAR
Rainer Glockler
OPHTHALMIC DRUGS: PATHWAY TO OVERCOME PRIMARY PACKAGING AND DRUG PRODUCT MANUFACTURING CHALLENGES
Rainer Glöckler, Carole Delauney, Dr Nicolas Eon and Katsuyuki Takeuchi discuss the myriad complexities of developing drug products for intravitreal injection, and how the partnership between swissfillon and Terumo can ease and accelerate these products to market. The first article, published in April, covered how swissfillon’s state-of-the-art filling line meets the complex requirements of ophthalmic drug products.
COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES
INJECTION
Matthias Bicker
COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES
Matthias Bicker, Michael Müller, Marc Mittermüller, Daniel Haines and Uwe Rothhaar discuss the regulatory requirements that need to be considered when designing an extractables and leachables study for a drug product or medical device. To illustrate the subject further, the authors provide two example studies, each following a different set of regulatory guidelines.
DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES
EXPERT VIEW
Suresh Gupta
DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES
Suresh Gupta discusses the challenges of developing a PFS product for intravitreal injection, highlighting how designing for the intravitreal space, rather than the standard parenteral, imposes a number of additional requirements on the design.
I-PLATFORM DEVICE: THE SMART DEVICE WITH APTITUDE
INJECTION
Jimmy Fan
I-PLATFORM DEVICE: THE SMART DEVICE WITH APTITUDE
Jimmy Fan outlines the capabilities and benefits of the I-Platform smart drug delivery device.
SURFACE-MEDIATED AGGREGATION – CONTROL OF THE LIQUID-SOLID INTERFACIAL STRESS
PREFILLED SYRINGES
Shane Smith
SURFACE-MEDIATED AGGREGATION – CONTROL OF THE LIQUID-SOLID INTERFACIAL STRESS
Shane Smith, Eoin Scanlan and Paula Colavita discuss how the company’s technology has evolved to create a stable and biocompatible coating that maintains device performance and safety.
INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY
INTERVIEW
Benjamin Dietiker
INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY
Benjamin Dietiker, Weidmann Medical Technology, talks with ONdrugDelivery about how the company has successfully implemented a growth strategy by focusing on key areas, plans for expansion, the effect of covid-19 on the business, and how the company differentiates itself from larger competitors by focusing on quality and service.
ROOM FOR INNOVATION?
EXPERT VIEW
Darren Mansell
ROOM FOR INNOVATION?
Darren Mansell examines US FDA guidance on biosimilar interchangeability and asks whether there is room for innovation.
CONSIDERATIONS FOR DEVICE SELECTION IN PARENTERAL APPLICATIONS
INJECTION
Mark Tunkel
CONSIDERATIONS FOR DEVICE SELECTION IN PARENTERAL APPLICATIONS
Mark Tunkel looks at the challenges involved in the selection of drug devices for combination products and the optimisation of the development process.
TOP FIVE DRUG DELIVERY TRENDS FOR 2021
EXPERT VIEW
Tom Oakley
TOP FIVE DRUG DELIVERY TRENDS FOR 2021
Tom Oakley provides an overview of the top five trends to expect in drug delivery in 2021.
PLATFORM TRAINING SOLUTIONS ADD VALUE FOR PHARMACEUTICAL COMPANIES
INJECTION
Alex Catino
PLATFORM TRAINING SOLUTIONS ADD VALUE FOR PHARMACEUTICAL COMPANIES
Alex Catino discusses the unmet need in healthcare for proper patient onboarding and training in the field of prefilled syringes and injection devices. Ms Catino uses Noble’s training device for Ypsomed’s YpsoMate® autoinjector as a case study for how bespoke training devices can be used to help improve the patient experience and adherence rates.
TACKLING PARENTERAL DRUG LABELLING’S SURGING COMPLEXITY
EXPERT VIEW
Lars Skole
TACKLING PARENTERAL DRUG LABELLING’S SURGING COMPLEXITY
Lars Skole discusses emerging trends and challenges associated with growing parenteral packaging and labelling complexity – and how pharmaceutical developers and manufacturers can meet the challenges ahead.
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