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.

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.

PREFILLED SYRINGES

William Fortina

Duoject

THE IMPORTANCE OF A GREAT DEVELOPMENT EXPERIENCE TO ACHIEVE A GREAT MEDICAL DEVICE

William Fortina considers the importance of the medical device development experience in the healthcare context and discusses the factors that make for a superior development process.

INJECTION

Dr Andreas Schneider

Ypsomed

HOW LONG CAN YOU HOLD THE DEVICE AGAINST THE SKIN? INSIGHTS FROM AN EMPIRICAL STUDY USING HAND-HELD AUTOINJECTORS

Andreas Schneider summarises recent empirical work investigating the ability of users of hand-held devices to complete longer injection times effectively. The study provides insights into the effects of injection duration on the force exerted by the user to hold the device against the injection site.

INDUSTRIALISATION

Ivan De Sanzo

Marchesini Group

PACKAGING LINE FOR GSK AUTOINJECTORS: A CASE STUDY

Ivan De Sanzo describes a unique automated complete packaging line provided to GlaxoSmithKline for three different autoinjectors.

EXPERT VIEW

Allison Strochlic

CONDUCTING EFFECTIVE AND INFORMATIVE EVALUATIONS OF INJECTION DEVICE PACKAGING

Allison Strochlic and Andrea Dwyer discuss the often overlooked aspect of a combination product user interface: the packaging. With a specific look at injection devices, the authors cover how to perform proper human factors testing of a combination product’s packaging, and the advantages doing so can confer to a project.

CONNECTIVITY

Sheila Trgovac

Ximedica

HOW DIGITAL TECHNOLOGY CAN TRANSFORM CLINICAL TRIALS

Sheila Trgovac and Rebecca Ford suggest that now is the time for innovation in clinical trials – using a patient-centric approach whilst leveraging digital solutions to create a digital clinical trial ecosystem.

SUSTAINABILITY

Dirk Borghs

Datwlyer

SMART GOALS AND CONTINUOUS IMPROVEMENT FOR A RESILIENT SUSTAINABILITY STRATEGY

Dirk Borghs considers the obligation of the pharmaceutical sector to implement environmentally responsible practices, and discusses the steps Datwyler is taking in its efforts for sustainability.

INDUSTRIALISATION

Doug Boyd

Battelle

CUSTOMISING PLATFORM DEVICES: CHALLENGES & CONSIDERATIONS

How do you choose the best delivery system for your drug? Doug Boyd explores the pros and cons of a cost-effective, off-the-shelf platform versus a custom drug delivery device, and discusses the challenges and considerations of customising an existing platform device.

INDUSTRIALISATION

Lars Keinicke Hansen

Stevanato Group

MEETING QUALITY DEMANDS THROUGH INTEGRATED PRODUCTS & SERVICES

Lars Keinicke Hansen; Chiara Mussoi and Odra Pinato describe how the streamlining of processes and harmonisation of products and services can better serve pharmaceutical companies. A case study highlights how a unique combination of expertise in automation and glass primary packaging benefited pharma giant Merck Serono in a recent project.

INDUSTRIALISATION

Pete Evans

Oval Medical Technologies

INTEGRATING DESIGN AND INDUSTRIALISATION TO OPTIMISE COST, QUALITY & TIME

Pete Evans and Meredith Canty explore how integrating design and industrialisation teams can optimise the cost, quality and time of developing a novel drug delivery system.