2022_Stevanato_Contract_Manufacturing_Skyscraper

PREFILLED SYRINGES

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.

SUCCESSFUL INDUSTRIALISATION REQUIRES SOLID FOUNDATIONS

INDUSTRIALISATION

West Pharmaceutical Services

SUCCESSFUL INDUSTRIALISATION REQUIRES SOLID FOUNDATIONS

Jennifer Riter and Victoria Morgan discuss the importance of choosing the right containment system at the start for successful industrialisation of an injectable drug product.

DIGITAL TWIN IN THE PHARMACEUTICAL SUPPLY CHAIN

DIGITAL TWIN IN THE PHARMACEUTICAL SUPPLY CHAIN

Gerresheimer’s Ali Badiei explains the role of digital twin technology and its integration into the pharmaceutical supply chain, highlighting an innovative approach to ensuring drug identity and quality.

Interview with Arnaud Guillet & Fanny Sellier

Interview with Arnaud Guillet & Fanny Sellier

Arnaud Guillet and Fanny Sellier talk with Guy Furness about how Biocorp has become a key player in the field of connected drug delivery, discuss the current landscape for connectivity in drug delivery and update us on its two major parenteral products – Mallya and Injay – as well as looking forward to the launch of the company’s next generation of connected drug delivery solutions.

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.

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.

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.

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.

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.

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.

AREAS TO WATCH IN CONNECTED DRUG DELIVERY DEVICE DEVELOPMENT

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.

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

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 OF CUSTOMISABLE PRODUCT PLATFORMS IN LIFE SCIENCES

INDUSTRIALISATION

Umit Ismail Tsavous

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.

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

INDUSTRIALISATION

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.

ADVANCED DELIVERY DEVICE TECHNOLOGY TO SIMPLIFY THE RECONSTITUTION OF LYOPHILISED DRUGS

Dr Fred Metzmann

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 with Biocorp’s Arnaud Guillet

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.

ISO 11608: WHAT THE NEW STANDARD MEANS FOR NIS MANUFACTURERS

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.

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

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.

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

PREFILLED SYRINGES

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.

UNLIMITED POSSIBILITIES BY USING A GAS-PRODUCING DRY CELL

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.

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

PREFILLED SYRINGES

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.

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

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.

OVERCOMING THE CHALLENGES OF ULTRA-LARGE-VOLUME SUBCUTANEOUS INFUSIONS

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.

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

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.

COMPANY SHOWCASE: Owen Mumford Pharmaceutical Services

PREFILLED SYRINGES

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.

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

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.

FROM SIMULATION TO SPRING SATISFACTION

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.

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