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INJECTION

INDUSTRIALISATION

INTEGRATED DRUG PRODUCT DEVELOPMENT AND MANUFACTURING

Andrea Allmendinger; Michael Adler and Hanns-Christian Mahler highlight the importance of integrated drug product development, considering aspects such as formulation, device, container closure system, manufacturing processes and usability, as well as considering the quality target product profile and clinical phase-appropriate technical development strategy.

ADDRESSING PEPTIDE THERAPEUTICS WITH A VERSATILE PEN PLATFORM

Cécile Gross and Mark Tunkel discuss the rising demand in peptide therapeutics and how Nemera’s PenVario pen injector platform, coupled with Nemera’s end-to-end service offering, has been designed to help pharma partners achieve success in this sector.

COLD STORAGE AND CONTAINER CLOSURE INTEGRITY – DEMONSTRATED PERFORMANCE OF ETFE-COATED COMPONENTS

Sebastien Cordier

COLD STORAGE AND CONTAINER CLOSURE INTEGRITY – DEMONSTRATED PERFORMANCE OF ETFE-COATED COMPONENTS

Sebastien Cordier; Benjamin Brocco; Estelle Verger and Arnaud Clausse discuss the results of a series of tests to demonstrate that PremiumCoat^® can maintain closure integrity down to -80°C.

ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS

ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS

Timothy Bubb discusses the five steps to setting up an effective post-market surveillance process.

DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS

DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS

Thomas James highlights the importance of early user engagement, as well as continuous refinement of information and workflow design, for efficient development of drug-device combination products for emergency use.

HOW PATIENT & TREATMENT FACTORS SHAPE SUBCUTANEOUS DOSING PREFERENCES

Dr Andreas Schneider

HOW PATIENT & TREATMENT FACTORS SHAPE SUBCUTANEOUS DOSING PREFERENCES

Andreas Schneider highlights the importance of understanding the drivers of dosing preferences when it comes to choosing the right injection device for patients. Specifically, the research summarised here studies whether and how patient characteristics and treatment attributes influence the decision to use prefilled handheld autoinjectors or large-volume wearable injectors.

TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS

TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS

John Burke considers the challenges that manufacturers need to overcome when designing emergency-use autoinjectors.

HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT

HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT

Finola Austin looks at the role human factors testing plays in the development of connected drug delivery devices.

STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS

STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS

Deepu Asok discusses the importance of test method validation for drug-device combination product development and how a common mistake is to design the validation process for a specific device rather than to accommodate the potential variety of a device platform.

OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES

Tomohiro Suzuki

Mitsubishi Gas Chemical

OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES

Tomohiro Suzuki reviews the advantages that OXYCAPT™, Mitsubishi Gas Chemical's multilayer material for vials, offers to biologics and gene and cell therapies, and discusses the results of recent tests into low-temperature storage and dimethyl sulfoxide resistance.

MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES

MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES

Eugene Polini discusses the importance of container closure for the parenteral drug market, including some of the consequences of compromised container closure and what steps manufacturers can take to ensure that primary packaging systems remain sealed for a product’s entire shelf life.

DESIGNING SUSTAINABILITY INTO PHARMACEUTICAL DEVICES

DESIGNING SUSTAINABILITY INTO PHARMACEUTICAL DEVICES

Will Davies discusses in detail how to address the challenges of designing sustainability into pharmaceutical devices.

SUSTAINABILITY IN DRUG DELIVERY: HOW DO WE GET THERE?

SUSTAINABILITY IN DRUG DELIVERY: HOW DO WE GET THERE?

Tim Wooller discusses the urgent need to transition away from disposable models of drug delivery device design and move towards reusables, providing insights into the reasons why and the methods by which this can be achieved.

OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION

Terumo Medical Care Solutions

OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION

Yuki Takeuchi and Richard Whelton discuss the challenges of delivering intravitreal injections and how the combination of Terumo’s PLAJEX™ prefillable syringes with Congruence’s Microlitre Dosing Syringe system is able to address them.

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Dr Andrea Allmendinger

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Andrea Allmendinger and Hanns-Christian Mahler highlight the technical challenges of intravitreal administration and considerations from the ophthalmologist’s and patient’s perspectives.

PATIENT-CENTRIC DESIGN CAN BE A FASTER PATH TO MARKET

Dr Brent Buchine

Windgap Medical

PATIENT-CENTRIC DESIGN CAN BE A FASTER PATH TO MARKET

Brent Buchine considers a faster path to market for automated and easy-to-use reconstitution devices through simplification of the delivery systems.

AN INTUITIVE ALL-IN-ONE AUTOINJECTOR: EMBEDDED MIXING & INJECTION TECHNOLOGIES SIMPLIFY DAY-TO-DAY LIFE

AN INTUITIVE ALL-IN-ONE AUTOINJECTOR: EMBEDDED MIXING & INJECTION TECHNOLOGIES SIMPLIFY DAY-TO-DAY LIFE

Benjamin Morel and Gladys Corrons-Bouis, discuss the challenges faced by the injectable drug delivery industry and present EVEON’s solution – the INTUITY^® Ject MX platform.

NEXT-GENERATION AUTOINJECTOR PLATFORM FOR HIGH-DOSE DRUGS

Richard Whelton

Congruence Medical Solutions

NEXT-GENERATION AUTOINJECTOR PLATFORM FOR HIGH-DOSE DRUGS

Richard Whelton introduces the new Congruence Autoinjector, a next-generation disposable autoinjector platform, which leverages a compressed-gas power source and has significant advantages over currently available legacy devices, including the ability to deliver higher viscosity and larger volume drugs, easier customisation and enhanced usability that addresses well-known user errors.

OPPORTUNITIES FOR INNOVATION WITH BIOSIMILARS

PREFILLED SYRINGES

Dr Iain Simpson

Phillips-Medisize

OPPORTUNITIES FOR INNOVATION WITH BIOSIMILARS

Iain Simpson and George Spooner investigate the use of drug delivery systems that support self-administration of biologic drugs, and specifically biosimilars, for the treatment of chronic diseases. This article is based on research conducted by both authors as part of the MPhil in Therapeutic Sciences at the University of Cambridge (UK) and supported by Phillips-Medisize.

Pro-Tects – A NOVEL SOLUTION TO THE CHALLENGE OF BIOLOGIC INSTABILITY

Glycome BioPharma

Pro-Tects – A NOVEL SOLUTION TO THE CHALLENGE OF BIOLOGIC INSTABILITY

Shane Smith, Eoin Scanlan and Paula Colavita discusses the difficulty inherent in developing parenteral biologic products due to the challenge of creating a stable formulation in the face of surface-mediated protein aggregation and introduces Pro-Tects – Glycome’s patented surface-treatment technology platform that offers a solution to this critical issue without introducing further development challenges.

ENABLING LARGE-VOLUME, HIGH-DOSE SUBCUTANEOUS AUTOINJECTIONS WITH CARTRIDGE-BASED TECHNOLOGIES

Michael McGowan

ENABLING LARGE-VOLUME, HIGH-DOSE SUBCUTANEOUS AUTOINJECTIONS WITH CARTRIDGE-BASED TECHNOLOGIES

Michael McGowan, examines the emerging interest in autoinjectors that are capable of delivering higher injection volumes into the subcutaneous space and considers the potential benefits of SHL Medical’s cartridge-based 3 and 5 mL Maggie^® autoinjectors.

ENABLING DRUG DEVELOPMENT THROUGH DRUG DELIVERY MANUFACTURING

Dr Andrei Yosef

ENABLING DRUG DEVELOPMENT THROUGH DRUG DELIVERY MANUFACTURING

Andrei Yosef looks at the role of manufacturing in the development of drug delivery devices and highlights the benefits of the company’s Sorrel device, which enables pharma companies to experiment during clinical trials to ensure that drugs produced are safe and cost-effective.

PRODUCT SHOWCASE: New Requirements for Injection Devices Make Advanced Testing Solutions Necessary

INDUSTRIALISATION

PRODUCT SHOWCASE: New Requirements for Injection Devices Make Advanced Testing Solutions Necessary

ZwickRoell showcases its advanced testing solutions for injection devices including pens, autoinjectors and on-body delivery systems.

OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES

PREFILLED SYRINGES

Yasuaki Yoshimura

Mitsubishi Gas Chemical

OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES

Yasuaki Yoshimura and Tomohiro Suzuki review the advantages that OXYCAPT, the company’s multilayer material for vials, offers to biologics and gene and cell therapies, and discuss the results of recent tests into low temperature storage and dimethyl sulfoxide resistance.

Interview: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen

Interview: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen

Mathias Romacker, Fran DeGrazio and Paul Jansen sit down with Guy Furness, to discuss what it is that has driven Kymanox’s rapid rise in the drug delivery space and what makes the consulting company’s model so successful, as well as to share their expertise on a variety of topics in an illuminating discussion, including connectivity, how large and small drug developers engage with consultancies, 5 mL autoinjectors and the interface between drug primary packaging and delivery devices.

SILICONE-OIL-FREE PREFILLED SYRINGE SYSTEMS – GUIDANCE FOR SELECTING THE APPROPRIATE PACKAGING MATERIALS AND FOR SILICONISATION

PREFILLED SYRINGES

SILICONE-OIL-FREE PREFILLED SYRINGE SYSTEMS – GUIDANCE FOR SELECTING THE APPROPRIATE PACKAGING MATERIALS AND FOR SILICONISATION

Bernd Zeiss addresses the influence of silicone oil on syringe systems and highlights the advantages and possibilities of novel silicone-oil-free prefillable syringes, both for glass and for plastic syringes.

Interview: Gabriel Zenker, Aptar Pharma

Interview: Gabriel Zenker, Aptar Pharma

Gabriel Zenker talks with ONdrugDelivery about Aptar Pharma’s ambitions for the parenterals sector. Mr Zenker explains how Aptar, already a major player in the pulmonary, nasal, ophthalmic and dermal markets, is undertaking a major expansion of its facilities, boosting the company’s capacity, capabilities and technologies, to provide its extensive service and product offering to the exciting injectables space.

ACCELERATING NOVEL THERAPIES TO THE CLINIC – CUSTOM SOLUTIONS

PREFILLED SYRINGES

Asmita Khanolkar

ACCELERATING NOVEL THERAPIES TO THE CLINIC – CUSTOM SOLUTIONS

Asmita Khanolkar discusses the key offerings necessary to accelerate “speed to clinic” for custom manufacturing solutions.

THE OPERATIONS PERSPECTIVE: BEST PRACTICES FROM 70 YEARS IN INJECTION DEVICE MANUFACTURING

THE OPERATIONS PERSPECTIVE: BEST PRACTICES FROM 70 YEARS IN INJECTION DEVICE MANUFACTURING

John Swift looks at how the company has evolved over 70 years, introduces its latest disposable autoinjector, Aidaptus, and considers how it plans to actively reduce risk in its supply chain.

LOW-COMPLEXITY, EASY-TO-USE WEARABLE INJECTION PLATFORM

LOW-COMPLEXITY, EASY-TO-USE WEARABLE INJECTION PLATFORM

Jesper Roested discusses the increasing prevalence of biologics formulated for large-volume injections in drug development and how wearable devices, including Subcuject’s offering, may be a better solution for delivering these drugs than scaled-up conventional autoinjectors.

REDUCE PHARMA DEVELOPMENT TIME: LARGE-VOLUME SUBCUTANEOUS DELIVERY WITH THE ENFUSE<sup>®</sup>

Enable Injections

REDUCE PHARMA DEVELOPMENT TIME: LARGE-VOLUME SUBCUTANEOUS DELIVERY WITH THE ENFUSE^®

Mehul Desai discusses how Enable Injections' enFuse^® delivery system provides a flexible alternative for subcutaneous administration of high-volume therapeutics.

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

PREFILLED SYRINGES

Dr Andrea Allmendinger

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

Andrea Allmendinger and Hanns-Christian Mahler both at ten23 health, provide an insight into the challenges of integrated development of drug product and device design and fill-finish manufacturing operations.

A TALE OF TWO SPRINGS

PREFILLED SYRINGES

Sebastian Block

Scherdel Medtec North America

A TALE OF TWO SPRINGS

Sebastian Block and Drew Jelgerhuis introduce two types of springs and highlight their important role in drug delivery devices.

ENGINEERING ADVANCES IN NEEDLE GEOMETRY TO ACCOMMODATE VISCOUS BIOLOGICS

Stevanato Group

ENGINEERING ADVANCES IN NEEDLE GEOMETRY TO ACCOMMODATE VISCOUS BIOLOGICS

Silvia Gallina discusses the challenges faced in administering highly viscous biologics to patients via subcutaneous injection, and how Stevanato Group’s new special thin-wall needles are able to tackle them.

BEING PREPARED FOR PHARMA INNOVATION IS KEY IN 2023

Victoria Morgan

West Pharmaceutical Services

BEING PREPARED FOR PHARMA INNOVATION IS KEY IN 2023

Victoria Morgan and Ana Marques Kuschel discuss three recent innovations that West Pharmaceutical Services has introduced to enable its partners to respond to specific market-driven challenges, from pandemic-driven pressures on fill-finish productivity to the underlying shift towards biologics and the accelerated growth of home-based treatment.

EXTRACTABLES/LEACHABLES TESTING CONSIDERATIONS FOR SINGLE-USE SYSTEMS

EXTRACTABLES/LEACHABLES TESTING CONSIDERATIONS FOR SINGLE-USE SYSTEMS

Sandi Schaible discusses testing considerations for extractables and leachables along with the regulatory environment for single-use systems.

Pharmapack Expert Panel on Patient-Centric Digital Health: Interview with Ben Cox, Team Consulting

Team Consulting

Pharmapack Expert Panel on Patient-Centric Digital Health: Interview with Ben Cox, Team Consulting

With Pharmapack returning to its traditional February timing in 2023, Team Consulting will be chairing a Day 1 expert panel discussion on patient-centric digital health solutions. Interviewed here, Ben Cox provides insight into trends the panel will discuss, lays out the current status of the industry with respect to digital health and considers what to look forward to at Pharmapack this year.

DESIGNING EFFECTIVE AND ENGAGING DIGITAL SOLUTIONS TO DRIVE ADHERENCE

Florian Krummenacher

DESIGNING EFFECTIVE AND ENGAGING DIGITAL SOLUTIONS TO DRIVE ADHERENCE

Florian Krummenacher and Philippe Müller discuss the effectiveness of combining connected injection devices with digital solutions to drive therapy outcomes.

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