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Prefilled Syringes & Injection Devices113

Issue No #113 Oct 2020 October 26th, 2020

Inside the magazine

THE NEW EMERGING NEEDS DRIVING AUTOINJECTOR DEVELOPMENT

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.

MEASURING & MANAGING MEDICATION ADHERENCE FROM CLINICAL TRIALS TO ROUTINE CARE: INJAY MEMS AS<sup>®</sup>

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.

THE “CUSTOMISABLE PLATFORM” PARADOX

INDUSTRIALISATION

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.

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

PREFILLED SYRINGES

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.

LEVERAGING INTEGRATION THROUGHOUT A DRUG DELIVERY SYSTEM PROJECT

INDUSTRIALISATION

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.

GERRESHEIMER INCLUDES STEVANATO GROUP INTEGRATED TWIST-OFF CLOSURE SYSTEM FOR GX<sup>®</sup> RTF SYRINGES

PREFILLED SYRINGES

Mr Maximilian Vogl

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.

VERIFYING THE CONTAINER CLOSURE INTEGRITY OF CUSTOM PRIMARY PACKAGING

PREFILLED SYRINGES

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.

UNISAFE<sup>®</sup> 2.25: SEAMLESSLY TRANSITIONING TO NEW-GENERATION BIOLOGICS

PREFILLED SYRINGES

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.

POLYMER SYRINGE CONSIDERATIONS FOR DRUG APPLICATIONS AND ADMINISTRATION

PREFILLED SYRINGES

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.

OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE

PREFILLED SYRINGES

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.

VERIFICATION OF INJECTABLES IN TRANSPORT AND STORAGE

PREFILLED SYRINGES

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.

ENHANCING PROTEIN PRESERVATION DURING BIOLOGICAL DRUG PREPARATION AND DELIVERY

Adrien Bouillet

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.

THE CHANGING FACE OF AUTOINJECTOR TECHNOLOGY

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.

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

PREFILLED SYRINGES

William Fortina

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.

PREPARING FOR MASS VACCINATION

PREPARING FOR MASS VACCINATION

Andy Fry and Stephen Blatcher discuss the need for a mass vaccination device in response to the 2020 covid-19 pandemic. In particular, the authors discuss the benefits and challenges of turning to needle-free injection technology as a solution.

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

Dr Andreas Schneider

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.

PACKAGING LINE FOR GSK AUTOINJECTORS: A CASE STUDY

INDUSTRIALISATION

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.

CONDUCTING EFFECTIVE AND INFORMATIVE EVALUATIONS OF INJECTION DEVICE PACKAGING

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.

HOW DIGITAL TECHNOLOGY CAN TRANSFORM CLINICAL TRIALS

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.