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.

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.

INDUSTRIALISATION

Frederick Gertz

SHL Medical

APPLICATIONS OF DEEP LEARNING IN MEDICAL DEVICE MANUFACTURING

Frederick Gertz and Gilbert Fluetsch look at how deep learning can be leveraged in a medical device manufacturing environment.

INDUSTRIALISATION

Diana Löber

SCHOTT

THE FUTURE OF SMART FILL-AND-FINISH

Diana Löber discusses new developments in digitised pharmaceutical manufacturing and the role SCHOTT’s Smart Containers can play in traceability along the entire value chain.

CONNECTIVITY

John Merhige

Credence MedSystems

THE AWARD-WINNING CREDENCE CONNECT™ AUTO-SENSING INJECTION SYSTEM

John Merhige explains how connectivity that is universally applicable to any existing prefilled syringe platform adds value throughout the ecosystem, both including and beyond the “compliance business model”.

CONNECTIVITY

Gaël Senée

Biocorp

SENSORS ARE TOOLS – BUT HOW DO YOU MAKE THEM SMART?

Gaël Senée and Arnaud Guillet explore the benefits of Mallya – a smart sensor that turns conventional injection pens into connected devices. They also discuss the crucial role Biocorp’s connected prefilled syringe, Injay, could play in future COVID-19 vaccination programmes.

INTERVIEW

Steven Kaufman

Stevanato Group

INTERVIEW WITH STEVEN KAUFMAN, STEVANATO & URI BARUCH, CDP

Steven Kaufman and Uri Baruch discuss the recently announced collaboration between their two companies to accelerate the development of a new variable-dose, cartridge-based pen injector platform for diabetes.

PREFILLED SYRINGES

Tomohiro Suzuki

Mitsubishi Gas Chemical

UPDATE ON OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE

Tomohiro Suzuki gives an update, including new oxygen barrier data, on the development of the OXYCAPT™ multilayer plastic vial and syringe.

EXPERT VIEW

Salvatore Forte

SENSOR ADVANCEMENTS IN DRUG DELIVERY IMPROVE COMPLIANCE

Salvatore Forte discusses various advancements in sensors that are transforming drug delivery systems, making complex devices more automated, easier to use, and improving patient compliance as a result.

PREFILLED SYRINGES

Aurelie Pager

BD (Becton Dickinson & Company)

Shorter Needles with Thinner Walls to Improve Injection Experience in Chronic Care

Aurélie Pager, Brigitte Duinat and Barbara Alves look at how new BD Neopak™ XtraFlow™ prefillable syringes with shorter, 8 mm needles and thinner-wall cannula technology are set to improve the injection experience for subcutaneous drug delivery in chronic care.

EXPERT VIEW

Mark Turner

WHICH IS THE BETTER TOXICITY TESTING STRATEGY FOR COMBINATION DEVICES?

Mark Turner explores the issue of toxicity testing for combination devices and asks which is the better testing strategy – ISO 10993 or extractables and leachables?

EXPERT VIEW

Beth Crandall

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

With the compliance deadline for the EU Medical Device Regulation recently delayed by a year due to the novel coronavirus pandemic, Beth Crandall looks at what it means for the medical device industry.

VIDEO

Equashield

Equashield^® Pro from Equashield

Closed System Transfer Device (CSTD) provider Equashield introduces Equashield^® Pro, the first CSTD-enabled automated drug compounding robot.

COVID-19 NEWS

Joe Reynolds

Noble

Telemedicine gains acceptance amid the Covid-19 pandemic

Noble highlights how telemedicine is poised to become a mainstream alternative to the traditional in-person methods of care delivery, with the covid-19 pandemic easing barriers to acceptance and introducing patients to the safety and convenience of telehealth technology.

PREFILLED SYRINGES

Gene Rhode Fuensalida Pantig

SHL Medical

ADDRESSING COMPLEX BIOLOGICS WITH RATIONAL DRUG DEVICE DESIGN

Gene Rhode Fuensalida Pantig reviews drug development over the years, the discovery of biologics as therapeutic agents and the emergence of autoinjectors, in correspondence with Hans Lin, PhD, a Research Fellow from Academia Sinica, Taiwan.