PREFILLED SYRINGES

OCULAR

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.

PREFILLED SYRINGES

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.

CONNECTIVITY

Finola Austin

Owen Mumford

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.

EXPERT VIEW

Deepu Asok

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.

INJECTION

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.

OCULAR

Dr Andrea Allmendinger

ten23 health

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.

INJECTION

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.

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.

INJECTION

Dr Shane Smith

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.

INDUSTRIALISATION

Peter Schmidt

ZwickRoell

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.

INTERVIEW

Guy Furness

Kymanox

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.

PREFILLED SYRINGES

Bernd Zeiss

Gerresheimer

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

Guy Furness

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.

PREFILLED SYRINGES

Asmita Khanolkar

SMC Ltd

ACCELERATING NOVEL THERAPIES TO THE CLINIC – CUSTOM SOLUTIONS

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

PREFILLED SYRINGES

Dr Andrea Allmendinger

ten23 health

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.

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.

INJECTION

Silvia Gallina

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.

INJECTION

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.

CONNECTIVITY

Michael Earl

Owen Mumford

AREAS TO WATCH IN CONNECTED DRUG DELIVERY DEVICE DEVELOPMENT

Michael Earl identifies areas of development in the field of connected drug delivery devices, providing an insight into what can be expected in the coming years. He draws on Owen Mumford’s own research, as well as discussions with industry experts and counterparts.

INJECTION

Reto Jost

Ypsomed

THE NEW YPSOMATE™ 5.5 – TAKING HANDHELD SELF-INJECTION BEYOND VOLUMES OF 2 ML

Reto Jost introduces YpsoMate 5.5, the staked-needle-syringe-based, two-step autoinjector for injection volumes in the 2.0–5.5 mL range, and discusses the drivers of the demand for high-volume, high-rate subcutaneous drug delivery using handheld autoinjectors.

INDUSTRIALISATION

Umit Ismail Tsavous

teamtechnik

INDUSTRIALISATION OF CUSTOMISABLE PRODUCT PLATFORMS IN LIFE SCIENCES

Umit Ismail Tsavous, Carsten Köhler and Tom Nägele discuss customisation of product platforms in the life sciences field.

INDUSTRIALISATION

Jake Canner

3P Innovation

DEVELOPING, MANUFACTURING AND DELIVERING A FILL-FINISH PILOT LINE FOR TUB-BASED PREFILLED SYRINGES

Jake Canner discusses the latest project arising out of 3P innovation’s partnership with Cambridge Pharma and its sister company Oval Medical Technologies – including the challenges involved and how they were overcome.

INJECTION

Dr Fred Metzmann

Haselmeier

ADVANCED DELIVERY DEVICE TECHNOLOGY TO SIMPLIFY THE RECONSTITUTION OF LYOPHILISED DRUGS

Fred Metzmann and Chris Muenzer present Haselmeier’s innovative approach to the development of reconstitution devices that allow easy and convenient administration of freeze-dried biologics.

INTERVIEW

Arnaud Guillet

Biocorp

Interview with Biocorp’s Arnaud Guillet

In this exclusive interview, Arnaud Guillet of Biocorp talks with ONdrugDelivery about connectivity in the injectables space, sharing some of the insights Biocorp has gained from its decade of experience in developing connected drug delivery devices.

INJECTION

Steve Augustyn

Cambridge Design Partnership

ISO 11608: WHAT THE NEW STANDARD MEANS FOR NIS MANUFACTURERS

Steve Augustyn looks at ISO 11608 and what it means for needle-based injection device manufacturers.

PREFILLED SYRINGES

Enrico Barichello

Stevanato Group

REALISING REDUCTIONS IN DEAD VOLUMES WITHIN PREFILLED SYRINGES: A MANUFACTURER’S PERSPECTIVE

Enrico Barichello considers the benefits of prefilled syringes, including cost and waste reduction, and looks at the impact and challenges of dead volume within the syringe.

PREFILLED SYRINGES

Taras Bredel

Injecto a/s

SILICONE-OIL-FREE, COATING-FREE, TUNGSTEN-FREE PREFILLABLE SYRINGES

Taras Bredel and Bernd Zeiss present the studies, development, performance and benefits of the Injecto lubrigone plunger stopper combined with the Gerresheimer RTF^® glass syringe – a silicone-oil-free, coating-free, tungsten-free, low-particle prefilled syringe solution for sensitive drug products.

INJECTION

Marc Beutler

simatec

UNLIMITED POSSIBILITIES BY USING A GAS-PRODUCING DRY CELL

Marc Beutler and Matthias Meier discuss the myriad advantages of using a gas-producing dry cell as a drive system for injectable drug delivery devices, as compared with spring-based and electromechanical drives.

PREFILLED SYRINGES

Audrey Chandra

Nemera

A HIGH-QUALITY AND ROBUST SAFETY SYSTEM FOR HIGH-VOLUME BIOLOGICS AT HOME

Audrey Chandra and Cécile Gross discuss Nemera’s development of a new product for the safe delivery of high-volume biologics at home.

PREFILLED SYRINGES

Victoria Morgan

West Pharmaceutical Services

REACHING A NEW ZENITH IN PROTECTING LARGER-VOLUME SENSITIVE MOLECULES, FROM FILLING TO SELF-ADMINISTRATION

Victoria Morgan and Eric Kurtz, discuss how West Pharmaceutical Services' Daikyo Crystal Zenith™ insert needle prefilled syringe system meets the needs presented by the healthcare sector’s shift to home-based care and the increasing prevalence of biologics in the pharmaceutical pipeline.

INJECTION

Rob Limouze

KORU Medical Systems

OVERCOMING THE CHALLENGES OF ULTRA-LARGE-VOLUME SUBCUTANEOUS INFUSIONS

Rob Limouze looks at the obstacles facing ultra-large-volume subcutaneous infusion drug delivery and highlights how the KORU Freedom infusion system meets these challenges.

EXPERT VIEW

Richard Whelton

AUTOINJECTORS: HISTORICAL ACHIEVEMENTS & COMPELLING NEEDS DRIVING NEXT-GENERATION DEVICES

Richard Whelton and Philip Green summarise the history of autoinjectors, highlight success stories to date, review the unmet needs that remain and consider emerging needs that could drive continued innovation in autoinjectors to ensure safety, patient satisfaction and pharma commercial success.

PREFILLED SYRINGES

Owen Mumford

COMPANY SHOWCASE: Owen Mumford Pharmaceutical Services

Owen Mumford Pharmaceutical Services specialises in the design, development and manufacture of injectable drug delivery systems for the pharma, biotech and generics industries. Its trusted devices are used daily in the delivery of various medications for a multitude of conditions across the globe.

INJECTION

Jimmy Fan

CC Bio

Technology Showcase: I-Platform from CCBio – How to Upgrade a Device in One Platform

CCBio showcases its I-Platform injectable drug delivery solution comprising: delivery units, including the electronic, connected Tesla device; containers and adapters; and safety needles.

INDUSTRIALISATION

Drew Jelgerhuis

Scherdel Medtec North America

FROM SIMULATION TO SPRING SATISFACTION

Drew Jelgerhuis discusses the power of simulation to enhance a drug delivery device design project, including faster development times and reduced costs.

INDUSTRIALISATION

Thomas Rudolph

Gerresheimer

INDUSTRIALISATION OF PHARMACEUTICAL AND MEDICAL DEVICES IN THE SCIENTIFIC MOULDING APPROACH

Thomas Rudolph, Markus Reil, Stefan Schumann and Tobias Weigert discuss Gerresheimer’s strategy for managing potential risks across the entire product lifecycle.

INDUSTRIALISATION

Dr Barry McDermott

West Pharmaceutical Services

INDUSTRIALISATION AND SCALE-UP OF DRUG DELIVERY DEVICES

Barry McDermott and Shari Krusniak look at the manufacturing processes involved in bringing a new drug delivery system and formulation to market.

INDUSTRIALISATION

Otto Abildgaard

Stevanato Group

EMBRACING OPPORTUNITIES PRESENTED BY DIGITALISATION: USING DATA TO DRIVE PERFORMANCE

Otto Abildgaard and Sebastian Berninger-Lund review the four-stage process Stevanato has developed to bring improvements in time to market through optimised manufacturing.