PREFILLED SYRINGES

PREFILLED SYRINGES

PREMIUMCOAT^® SOLUTIONS: HELPING CONTROL THE LEVEL OF SILICONE TO PROTECT SENSITIVE THERAPEUTICS

Sébastien Cordier, Vincent Holterboch and Estelle Verger discuss how coated elastomer components, such as Aptar Pharma’s PremiumCoat^®, can help drug developers optimise the balance between component processability and minimising silicone migration into a drug product.

PREFILLED SYRINGES

OXYCAPT™: A SUPERIOR PRIMARY CONTAINER MATERIAL FOR BIOLOGICS AND GENE AND CELL THERAPIES

Hiroki Hasegawa and Tomohiro Suzuki provide an overview of the OXYCAPT multilayer vial and syringe, along with a discussion of how OXYCAPT fares at low and very low temperatures.

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.

INDUSTRIALISATION

Tracy Pedreso

SHL Medical

CONTINUOUS IMPROVEMENT: FROM ABSTRACTION TO REALITY

Tracy Pedreso discusses SHL Medical’s strategy for making continuous improvement a reality.

INDUSTRIALISATION

Mark Tunkel

Nemera

HOLISTIC DEVELOPMENT & INDUSTRIALISATION OF DRUG DELIVERY DEVICES & COMBINATION PRODUCTS

Mark Tunkel and Niyati Sapatnekar discuss Nemera’s holistic approach to development and industrialisation.

INTERVIEW

Piyush Agarwal

INTERVIEW: Piyush Agarwal, Tjoapack

Piyush Agarwal talks with ONdrugDelivery about the current state of the injectable pharmaceuticals market and how working with a specialist contract packaging organisation can help pharma companies navigate their product through this rapidly evolving sector and deliver their product to market on time.

CONNECTIVITY

Aurelie Pager

BD (Becton Dickinson & Company)

A PATIENT-CENTRIC, CONNECTED INJECTION DEVICE FOR DECENTRALISED CLINICAL TRIALS – THE HUMAN FACTORS RESULTS ARE IN!

 Aurélie Pager and Mircea Despa follow up on an article published in the December 2021 issue of ONdrugDelivery. BD has now completed a human factors study assessing the usability, acceptance and ease of use of its connected injection prototype for clinical trials.

INJECTION

Jonathan Kearns

SHL Medical

PUTTING PROCESS ENGINEERING INTO ACTION

Jonathan Kearns and Kevin Huang consider how engineering competencies are being driven to the next level by leveraging process engineering and how this can transform drug-device projects.

INJECTION

Dr Fred Metzmann

Haselmeier

EXCELLENCE THROUGH SIMPLICITY: PICCOJECT™ AUTOINJECTOR PLATFORM

Fred Metzmann and Chris Muenzer discuss the simplicity of the PiccoJect™ autoinjector platform and the company's commitment to sustainability.

EXPERT VIEW

Dr Martin Gonzalez

RECENT TRENDS & DEVELOPMENTS IN INJECTABLE FORMULATION & DELIVERY

Martin Gonzalez details current trends in sterile injectable formulations and their delivery devices, and the challenges pharma and its contract development and manufacturing company partners face in bringing emerging breakthroughs to market.

INTERVIEW

Steven Kaufman

Stevanato Group

INTERVIEW: STEVEN KAUFMAN, STEVANATO GROUP, & MICHAEL EARL, OWEN MUMFORD

In this exclusive interview, Steven Kaufman of Stevanato Group, and Michael Earl of Owen Mumford, talked with us about their companies' recent major agreement for the manufacturing and provision of prefillable syringes for the advanced two-step, single-use autoinjector, Aidaptus^®.

SUSTAINABILITY

Fran Penrose

Cambridge Design Partnership

SUSTAINABILITY: WHAT CAN THE HEALTHCARE SECTOR LEARN FROM CONSUMER DESIGN?

Fran Penrose considers the lessons the healthcare sector can draw from the fast-moving consumer sector when designing for sustainability and asks, “Can we go even further?”

SUSTAINABILITY

Rob Doorakkers

IGS GeboJagema

SMART SOLUTIONS TO REDUCE CARBON FOOTPRINT

Rob Doorakkers and Geert van Amstel discuss why the company decided to become carbon neutral, how it is working to make injection moulding more sustainable and how the organisation is minimising its impact on the environment.

SUSTAINABILITY

Dr Pierre Moulinie

Covestro LLC

DESIGNING DRUG DELIVERY DEVICES TO MEET EMERGING NEEDS AND SUSTAINABILITY GOALS

Pierre Moulinié, Isaac Platte and Lauren Zetts discuss how polycarbonate-based materials deliver value to emerging drug delivery devices.

SUSTAINABILITY

Emil Fraenkel

Phillips-Medisize

SUSTAINABILITY WITH THE ARIA AUTOINJECTOR: THE ROUTE TO FURTHER IMPROVEMENTS

Emil Fraenkel and Bjarne Sørensen investigate the route to further sustainability improvements for the Aria autoinjector. This article is a sequel to a benchmark study on the environmental impact of Aria presented by Phillips-Medisize in ONdrugDelivery Issue 126 (Oct/Nov 2021).

OCULAR

Dr Andrea Allmendinger

ten23 health

HOW TEN23 HEALTH IS MEETING DEVELOPMENTAL CHALLENGES FOR INTRAVITREAL PRODUCTS

Andrea Allmendinger and Hanns-Christian Mahler highlight new regulatory and quality requirements for intravitreal applications and discuss technical challenges during drug product technical development and manufacturing.

OCULAR

Dr Gautam N Shetty

Congruence Medical Solutions

OPHTHALMIC INJECTION OF VISCOUS FORMULATIONS – WHY UNIQUE NEEDS REQUIRE A NOVEL DELIVERY APPROACH

Guatam Shetty and Richard Whelton outline the key considerations related to ophthalmic injection of viscous formulations and propose an innovative, user-validated and fully mechanical device-based solution.

EXPERT VIEW

Michael Neely

A VIEW ON THE USE OF APROTIC SOLVENTS IN PARENTERAL DRUG FORMULATIONS

Michael Neely presents a review and discussion of the status of aprotic solvents as a solubilising vehicle for parenteral drug formulations in the context of the industry’s increasing interest in biologic drugs.

INDUSTRIALISATION

Rob Doorakkers

IGS GeboJagema

HOW MODEL BASED DEFINITION REVOLUTIONISES THE PRODUCTION OF MEDICAL DEVICES

Rob Doorakkers looks at the advantages of the IGS GeboJagema’s Model Based Definition process and its ability to improve the quality of medical device production.

INJECTION

Olivia Jefferies

SMC Ltd.

COMPUTATIONAL MODELLING OF INJECTION-RELATED TISSUE RESPONSES IN DRUG DELIVERY

Olivia Jefferies, Elizabeth Margerison and Asmita Khanolkar introduce Oval’s work on using ultrasound scanning and finite element analysis to construct a model of how tissue compresses under use of an autoinjector across patient demographics, and how this may provide insights into improved autoinjector design for more accurate injection depths, improving patient outcomes.

EXPERT VIEW

Tom Oakley

DRUG DELIVERY DEVICE TRENDS FOR 2022

Tom Oakley looks at some of the current trends in the drug delivery industry and projects some of the key factors that will influence drug delivery decision making in 2022.

SUSTAINABILITY

Michael Earl

Owen Mumford

SO FAR SO GOOD: MAINTAINING THE MOMENTUM OF PROGRESS FOR SUSTAINABLE POLICIES

Michael Earl discusses the highlights of a review undertaken by Owen Mumford into how the pharmaceutical industry is faring on environmental, social and governance standards, noting that while the industry is performing above average overall, there remain some key areas for improvement.

EXPERT VIEW

Dr Celeste Maksim

MDR COMPLIANCE: PLANNING FOR POST-MARKET CLINICAL FOLLOW-UP

Celeste Maksim discusses best practices for drug delivery device manufacturers when conducting post-market clinical follow-up activities, as mandated by the EU Medical Device Regulation.

PREFILLED SYRINGES

Michelle Deutsch

SCHOTT

TAKING INTEGRATED NEEDLE SAFETY SYSTEMS FOR PREFILLED SYRINGES TO THE NEXT LEVEL

Michelle Deutsch and John Merhige discuss the needle safety requirements of prefilled syringes and consider how SCHOTT TOPPAC^® and syriQ^® PFS with Credence Companion^® technology combine to meet these challenges, while ensuring the device meets sustainability demands.

PREFILLED SYRINGES

Victoria Meyer

BD (Becton Dickinson & Company)

NEW BD SCF™ PREMIUMCOAT^® 1MLL PLUNGER STOPPER: GLIDING TOWARDS DE-RISKED COMBINATION PRODUCT DEVELOPMENT

Victoria Meyer introduces the BD SCF™ PremiumCoat^® 1mlL Plunger Stopper and explains how the product’s role is critical in determining combination products’ exposure to extractables and leachables.

PREFILLED SYRINGES

Dr Martin Gonzalez

Pfizer CentreOne

FROM VIAL TO PREFILLED SYRINGE: MIGRATING A DRUG PRODUCT PRESENTATION

Martin Gonzalez discusses some of the most relevant engineering activities that are necessary to transfer a product successfully from a vial into a prefilled syringe presentation.

PREFILLED SYRINGES

Yoshiko Sakuma

Mitsubishi Gas Chemical

PHOTO-STABILITY TESTS OF EPINEPHRINE

Yoshiko Sakuma and Tomohiro Suzuki provide an overview of OXYCAPT multilayer vial and syringe, with a particular emphasis on the advantages of OXYCAPT as a container for adrenaline, as demonstrated by recent studies conducted by MGC.

INTERVIEW

Arnaud Guillet

Biocorp

Interview: Arnaud Guillet, Biocorp

In this exclusive interview with ONdrugDelivery, Arnaud Guillet discusses Mallya, Biocorp’s connected clip-on for pen injectors, including Mallya’s successful launch in multiple countries this year, the factors that have played into the device’s success, and the future for Mallya, Biocorp and connectivity in the drug delivery industry.

CONNECTIVITY

Philippe Müller

Ypsomed

YPSOMATE ON – GO FOR SIMPLY CONNECTED

Philippe Müller and Silas Mächler discuss the benefits of integrated digital therapy management systems and the role of YpsoMate On –  the newest addition to Ypsomed’s connected device portfolio, and the world’s first prefilled autoinjector with integrated connectivity that automatically logs injections on the user’s therapy management app.

CONNECTIVITY

Rebecca Beck

BD (Becton Dickinson & Company)

TRIALS WITHOUT TRIBULATIONS: A PATIENT-CENTRIC, CONNECTED INJECTION DEVICE FOR DECENTRALISED AND HYBRID CLINICAL TRIALS

Rebecca Beck and Hervé Monchoix discuss how stakeholder needs are driving the development of a new, connected injection device from BD, to support decentralised and hybrid clinical trials.

ROUNDTABLE

Sebastian Gerner

Alliance to Zero

ROUNDTABLE: ALLIANCE TO ZERO

Sebastian Gerner, Robert O’Beirn and Sabrina Gérard talk with ONdrugDelivery about the Alliance to Zero, an association for pharma and biotech supply chain companies that aims to facilitate the transition of the pharma sector to compliance with net-zero emissions.

SUSTAINABILITY

Peter Soelkner

Vetter Pharma

STRATEGIES TO ACHIEVE LONG-TERM SUSTAINABILITY

Peter Soelkner and Thomas Otto discuss how the pharmaceutical service provider focuses on sustainability.

SUSTAINABILITY

Emil Fraenkel

Phillips-Medisize

SUSTAINABILITY WITH THE ARIA AUTOINJECTOR: A LIFECYCLE ASSESSMENT

Emil Fraenkel and Bjarne Sørensen consider the sustainability of re-usable and disposable autoinjectors, its implications in adding connectivity to drug delivery devices and how it has been an important consideration for Phillips-Medisize in the development of the Aria re-usable autoinjector. 

SUSTAINABILITY

Julie Cotterell

Owen Mumford

FORMULATION DEVELOPMENT AND DRUG DELIVERY: JOINED AT THE DEVICE

Julie Cotterell discusses the major factors at play driving the direction of innovation in the subcutaneous drug delivery space, with a particular emphasis on the push towards patient self-administration.

INJECTION

Andrew Moore

SHL Medical

CREATING TIMELESS DEVICE TECHNOLOGIES

Andrew Moore and Gene Rhode Fuensalida Pantig discuss the importance of a sound strategy for product lifecycle management.