PREFILLED SYRINGES

PREFILLED SYRINGES

A NOVEL PREFILLABLE SYRINGE WITH A GLASS PRIMARY CONTAINER BUT NO NEED FOR EXTREME THERMAL REFORMING

Stephen Shue introduces a proprietary prefillable syringe, the SMPFS, whose novel glass-tube-plus-plastic-sheath design enables the use of a standard glass tube primary drug container, but avoids the need for the extreme thermal reforming process that conventional glass prefillable syringes must undergo.

INJECTION

THE NEXT GENERATION OF COATED PLUNGERS

Carina Van Eester explores the benefits of fully coated plungers for prefilled syringes and cartridges.

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.

INJECTION

Karima Yadi

BD (Becton Dickinson & Company)

INNOVATING IN THE VISCOSITY DESIGN SPACE: A NEW 2.25 ML AUTOINJECTOR PLATFORM

Karima Yadi and Lionel Maritan discuss BD’s response to the need for an autoinjector platform that reconciles the demands of biologics with safety, reliability and ease of use during self-injection: the Intevia™ 2.25 mL disposable autoinjector.

EXPERT VIEW

George I’ons

CONNECTED DRUG DELIVERY: ACHIEVING OPTIMAL BENEFITS THROUGH SMART COLLABORATION

George I’ons discusses the challenges developing connected devices presents to key market stakeholders when it comes to successful rollout and implementation. Additionally, he considers the perspectives of these market players, as well as the patients themselves, with respect to how connected drug delivery devices can help them to better achieve their desired outcomes.

INJECTION

Dr Iain Simpson

Phillips-Medisize

THE NEW EMERGING NEEDS DRIVING AUTOINJECTOR DEVELOPMENT

Iain Simpson discusses the emerging needs to be considered when bringing new autoinjector drug-device combinations to market.

CONNECTIVITY

Arnaud Guillet

Biocorp

MEASURING & MANAGING MEDICATION ADHERENCE FROM CLINICAL TRIALS TO ROUTINE CARE: INJAY MEMS AS^®

Arnaud Guillet and Bernard Vrijens discuss the issue of medication non-adherence in both clinical trials and commercialised drug products, and how Biocorp’s Injay connected prefilled syringe solution combined with Aardex’s MEMS Adherence Software provides a solution.

INDUSTRIALISATION

Lyndon Wild

SHL Medical

THE “CUSTOMISABLE PLATFORM” PARADOX

Lyndon Wild and Gene Rhode Fuensalida Pantig present a systematic analysis of the customisable platform architecture found in the Molly^® autoinjector technology.

PREFILLED SYRINGES

Joe Reynolds

Noble

TRAINING DEVICES & PATIENT EDUCATION PLAY A CRUCIAL ROLE IN THE SELF-INJECTION DRUG DELIVERY MARKET

Joe Reynolds discusses the role training devices and patient education play with regard to self-injection therapies.

INDUSTRIALISATION

Steven Kaufman

Stevanato Group

LEVERAGING INTEGRATION THROUGHOUT A DRUG DELIVERY SYSTEM PROJECT

Steven Kaufman and Adam Stops describe how an integrated offering can help customers at each phase of a drug delivery system project.

PREFILLED SYRINGES

Mr Maximilian Vogl

Gerresheimer

GERRESHEIMER INCLUDES STEVANATO GROUP INTEGRATED TWIST-OFF CLOSURE SYSTEM FOR GX^® RTF SYRINGES

Maximilian Vogl reveals the latest user-friendly addition to its Gx RTF Luer lock syringes using Stevanto Group’s integrated twist-off closure technology.

PREFILLED SYRINGES

George I’ons

Owen Mumford

UNISAFE^® 2.25: SEAMLESSLY TRANSITIONING TO NEW-GENERATION BIOLOGICS

George I’ons discusses the benefits of subcutaneously administering new drug formulations, and the factors that manufacturers need to consider when designing delivery devices.

PREFILLED SYRINGES

Dr Alex Vasiev

Oval Medical Technologies

VERIFYING THE CONTAINER CLOSURE INTEGRITY OF CUSTOM PRIMARY PACKAGING

Alex Vasiev, Connor Everett and Steven Hay explore the challenges of verifying the container closure integrity of custom primary packaging.

PREFILLED SYRINGES

Tibor Hlobik

West Pharmaceutical Services

POLYMER SYRINGE CONSIDERATIONS FOR DRUG APPLICATIONS AND ADMINISTRATION

Tibor Hlobik compares cyclo-olefin polymers and copolymers with glass as the material of choice for prefilled syringes, in particular discussing the benefits of polymers when it comes to biologic drug products and prefilled syringes for use in autoinjectors.

PREFILLED SYRINGES

Shota Arakawa

Mitsubishi Gas Chemical

OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE

Shota Arakawa and Tomohiro Suzuki discuss MGC’s OXYCAPT™ vial and syringe primary containers, including the OXYCAPT™ material and product offering, as well as where MGC sees OXYCAPT™ fitting into the modern pharmaceutical market.

PREFILLED SYRINGES

Mark Turner

Medical Engineering Technologies

VERIFICATION OF INJECTABLES IN TRANSPORT AND STORAGE

Mark Turner discusses the regulations and requirements around testing combination products for their stability in storage over their shelf-life and during transport.

INJECTION

Adrien Bouillet

Eveon

ENHANCING PROTEIN PRESERVATION DURING BIOLOGICAL DRUG PREPARATION AND DELIVERY

Adrien Bouillet, Loïc Girois and Marianne Weidenhaupt, discuss the results of work carried out in joint efforts by EVEON and LMGP in the field of protein adsorption and aggregation, and how the results of this work have led to improvements in the design of EVEON’s proprietary micropump.

INJECTION

Bespak by Recipharm

THE CHANGING FACE OF AUTOINJECTOR TECHNOLOGY

Reenal Gandhi discusses the advantages offered by liquefied gas as a power source for autoinjectors compared with conventional spring-based systems, as well as covering the benefits of using a platform model for drug delivery device development.