PREFILLED SYRINGES

INDUSTRIALISATION

RELENTLESS PRECISION DELIVERS VALUE IN NEEDLE-HANDLING AUTOMATION FOR COMBINATION PRODUCTS

William Jaworski and Michael Gunner discuss the precision and complex manipulation of needles required for the latest combination medical products.

PREFILLED SYRINGES

GX INNOSAFE – GREATER PROTECTION AGAINST NEEDLESTICK INJURIES

Wenzel Novak and Stefan Verheyden introduce Gx InnoSafe, a novel integrated passive needle safety system for preventing needlestick injuries and accidental reuse of syringes that minimises additional burden on healthcare workers during injection and can be integrated into existing pharmaceutical filling operations without the need for adaptation or conversion of processing lines.

INJECTION

Andrew Moore

SHL Medical

CREATING TIMELESS DEVICE TECHNOLOGIES

Andrew Moore and Gene Rhode Fuensalida Pantig discuss the importance of a sound strategy for product lifecycle management.

INTERVIEW

Mathias Romacker

INTERVIEW WITH MATHIAS ROMACKER, EX-PFIZER, INJECTION DEVICES STRATEGY CONSULTANT

In this exclusive interview, Mathias Romacker discusses a broad range of topics, from his professional expertise and history seeing the parenteral sector evolve first-hand, to his personal experience as a Crohn’s disease patient making use of the very devices he’s seen grow and develop.

INJECTION

Carsten Köhler

teamtechnik

FULLY AUTOMATED ASSEMBLY AND FUNCTIONAL TESTING FOR PEN INJECTORS AND AUTOINJECTORS

Carsten Köhler, Umit Ismail Tsavous and Gerd Vosshage explain the company’s processes for the automated assembly and testing of pen and autoinjectors.

INJECTION

Michael Roe

KALEO

CHALLENGES IN HIGH-VISCOSITY, HIGH-VOLUME DRUG DELIVERY

Michael Roe discusses the development of the Aerio™ Platform of gas-powered injection systems.

INJECTION

Jennifer Quint

Pfizer CentreOne

THREE PHASES TO SUCCESS IN STERILE INJECTABLES TECHNOLOGY TRANSFER

Jennifer Quint offers insights into how to plan and execute technology transfer effectively, explaining Pfizer CentreOne’s three-phased approach that can successfully support this pivotal event in a drug product programme’s journey to commercialisation.

INDUSTRIALISATION

Wolfgang Moersch

ZwickRoell

PRODUCT SHOWCASE: ZwickRoell – Comprehensive Automated Testing Solutions

ZwickRoell showcases its comprehensive automated testing solutions.

INJECTION

Asmita Khanolkar

SMC Ltd.

A NEW MINDSET FOR COMBINATION PRODUCT DEVELOPMENT

Asmita Khanolkar outlines the latest trends in combination product development to overcome some of the current challenges of high dose/viscosity/volume delivery.

INJECTION

Michael Earl

Owen Mumford

AIDAPTUS^®: OWEN MUMFORD INTRODUCES ITS NEXT-GENERATION PLATFORM AUTOINJECTOR

Michael Earl introduces the next-generation Aidaptus^® autoinjector, explaining how this latest platform device from Owen Mumford can contribute to a faster speed-to-market, increased flexibility during drug development and improved patient outcomes.

INTERVIEW

Stephen Perry

Kymanox

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.

PREFILLED SYRINGES

Yoshiko Sakuma

Mitsubishi Gas Chemical

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.

INDUSTRIALISATION

Lucy Chung

SHL Medical

DEVELOPING A FULLY AUTOMATED MODULAR MACHINE PLATFORM FOR AUTOINJECTOR TESTING

Lucy Chung and Gilbert Fluetsch discuss the benefits of a modular automated test platform.

INDUSTRIALISATION

Sam Eubanks

BD (Becton Dickinson & Company)

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.

INDUSTRIALISATION

Jens Schou Christensen

Stevanato Group

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.

INDUSTRIALISATION

John Swift

Owen Mumford

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.

INDUSTRIALISATION

Hiroki Hasegawa

Mitsubishi Gas Chemical

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.

CONNECTIVITY

Napoleon Monroe

New Directions Technology Consulting

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.

INJECTION

Markus Goldinger

SHL Medical

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.

INJECTION

Dr Andreas Schneider

Ypsomed

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.

INJECTION

Anthony Vico

Stevanato Group

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

Caroline Zakrzewski

Cambridge Design Partnership

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.

CONNECTIVITY

Bjarne Sørensen

Phillips-Medisize

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.

OCULAR

Rainer Glockler

Swissfillon

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.

INJECTION

Dr Matthias Bicker

SCHOTT

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.

EXPERT VIEW

Dr 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.

INJECTION

Jimmy Fan

CC Bio

I-PLATFORM DEVICE: THE SMART DEVICE WITH APTITUDE

Jimmy Fan outlines the capabilities and benefits of the I-Platform smart drug delivery device.

PREFILLED SYRINGES

Dr Shane Smith

Glycome BioPharma

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

Benjamin Dietiker

Weidmann Medical Technology

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.

EXPERT VIEW

Darren Mansell

ROOM FOR INNOVATION?

Darren Mansell examines US FDA guidance on biosimilar interchangeability and asks whether there is room for innovation.

INJECTION

Mark Tunkel

Nemera

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.

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.

INJECTION

Alex Catino

Noble

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.

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.

CONNECTIVITY

Arnaud Guillet

Biocorp

INJAY: SIMPLE BY CHOICE, ADAPTABLE BY DESIGN

Arnaud Guillet discusses Biocorp’s Injay solution for adding connectivity to a wide variety of PFS devices, focusing on how Injay’s designed-in simplicity and flexibility makes it easily applicable across the spectrum of PFS platforms on the market today.

PREFILLED SYRINGES

Carina Van Eester

Datwlyer

BUILDING A BETTER PREFILLED SYRINGE FOR COVID-19 VACCINE PACKAGING

Carina Van Eester shares key learnings since the launch of the company’s NeoFlex plungers at the start of the covid-19 pandemic.

PREFILLED SYRINGES

Finola Austin

Owen Mumford

AN INCLUSIVE APPROACH TO THE DEVELOPMENT OF PLATFORM MEDICAL DEVICES

Finola Austin discusses the difficulties presented by designing a user testing programme for platform devices when the target patient population is as yet unknown, and presents the testing framework based on seven user groups that Owen Mumford uses to meet this challenge.

PREFILLED SYRINGES

Sophie Trémeau

BD (Becton Dickinson & Company)

BD HYLOK™ – GLASS PREFILLABLE SYRINGE FOR IV APPLICATIONS

Sophie Trémeau, Maxime Nicolas and Myriam Leszczynski discuss BD Hylok™, a prefillable glass syringe for intravenous applications, including the rigorous testing BD Hylok™ has undergone and the regulatory support BD is able to provide to its pharmaceutical partners.