PREFILLED SYRINGES

INDUSTRIALISATION

Berthold Schopferer

Z.BLIZZARD AUTOMATION SYSTEM – IT DOESN’T GET MORE TAILOR-MADE THAN THIS

Berthold Schopferer explains how the Zahoransky’s integrated syringe manufacturing and assembly equipment allows maximum customisation and full customer involvement.

BD (Becton Dickinson & Company)

Cecile Halte, BD

In this interview, Cécile Halté, Senior Program Manager, Acute Care Segment, for BD Medical – Pharmaceutical Systems. discusses validation studies of the BD Sterifill Advance™ plastic prefilled syringe, which is intended for use in the hospital setting by healthcare professionals either for manual bolus injections, or with infusion pumps.

INDUSTRIALISATION

Michael Wiglenda

Gerresheimer AG

A FIVE-STEP APPROACH TO INNOVATION IN DRUG DELIVERY SYSTEMS

Michael Wiglenda explains Gerresheimer’s industrialisation offering and the five-step Gate-Model that guides its innovation process.

Dr Mircea Despa

BD (Becton Dickinson & Company)

MIRCEA DESPA & DOUG McCLURE, BD

In this interview, Dr Despa and Mr McClure discuss BD’s approach to connecting devices in its portfolio to meet patient, pharma and other stakeholder requirements. Their discussion focuses in particular on safety and security, highlighting the connected wearable injector, BD Libertas™ with Smart Option, as an example.

#97_May_2019_Credence_featured

Credence MedSystems

TECHNOLOGY SHOWCASE: Credence MedSystems Multi-Site™ Injection System

Credence MedSystems introduces the Multi-Site™ Injection System – a product that addresses specific needs in the high-growth dermal filler market.

Feature image

BD (Becton Dickinson & Company)

SELECTING THE RIGHT PRIMARY CONTAINER FOR INJECTABLES IN ACUTE CARE

Alfred Harvey explains why it’s important to select the right primary container presentation – and what can happen if you get it wrong.

Figure 1: OXYCAPT™ Vials and Syringes.

Takuya Minezaki

Mitsubishi Gas Chemical

MULTILAYER PLASTIC VIALS & SYRINGES FOR BIOLOGICS

Dr Takuya Minezaki and Tomohiro Suzuki, provide an overview of the company’s OXYCAPT™ Vials and Syringes, explaining how their multi-layered polymer material delivers the advantages of both COP and glass, and is especially suitable for biotherapeutics.

Zahoransky_featured

Berthold Schopferer

NEXT-LEVEL FUTURE MANUFACTURING FOR MEDICAL TECHNOLOGY

Berthold Schopferer explains the lengths the production equipment company goes to in its efforts to ensure the customer is always king.

Phillips Med, feature image

Bjarne Sørensen

Phillips-Medisize

A RE-USABLE CONNECTED AUTOINJECTOR CUSTOMISED FOR THE COMPANION^® SAFETY SYRINGE SYSTEM

Bjarne Sørensen and John A. Merhige explore the latest developments in modular autoinjector platforms and the benefits for end users and pharmaceutical customers. They also discuss the two companies’ recent partnership for the development of a combined system that capitalises on important synergies between two compatible technologies.

PREFILLED SYRINGES

SOLUTIONS FOR HIGH-VOLUME DRUG DELIVERY

SHL Group introduces the high-volume variation of its Molly^® family of products, the Molly^® 2.25, and discusses more broadly the advantages that the Molly^® business model offers to pharmaceutical and biotech clients.

PREFILLED SYRINGES

TECHNOLOGY SHOWCASE: teamtechnik’s LED Cannula Gluing Process

Ingo Stephan introduces a new gluing process for attaching cannulas using LEDs from teamtechnik.

PREFILLED SYRINGES

Justin Schroeder

PCI Pharma Services

BIOLOGIC MEDICINES AND PATIENT-CENTRICITY – A NEW PHASE OF HOPE

Justin Schroeder discusses how the increasing biologics and biosimilars market has driven innovation and a trend towards self-administration and user-centricity in the injectable drug delivery device market.

BD (Becton Dickinson & Company)

SAGAR BEJALWAR, BD MEDICAL – PHARMACEUTICAL SYSTEMS

Sagar Bejalwar discusses the product and clinician needs in delivering hyaluronic acid for cosmetic applications.

HAZARDOUS DRUG HANDLING AND INVESTIGATIONAL DRUGS: LESSONS TO LEARN

Marino Kriheli discusses the need for closed-system transfer devices when handling hazardous drugs, particularly as they relate to investigational drugs, not only as key to patient and healthcare practitioner safety, but also in the context of upcoming US regulation.

PREFILLED SYRINGES

Dr Eric Chappel

LOW-COST DISPOSABLE WEARABLE INJECTOR PLATFORM FOR LARGE VOLUMES OF VISCOUS DRUGS

Eric Chappel, Dimitry Dumont-Fillon and Laurent-Dominique Piveteau discuss Debiotech’s novel wearable injector technology, which utilises a propellant vapour system to drive the injection, making the device both space- and cost-efficient.

SIX TECHNIQUES FOR RAPID EARLY-STAGE MEDICAL DEVICE DEVELOPMENT

Stuart Curtis runs through six techniques which, in his experience, are invaluable for accelerating the early development stages of drug delivery device design and can therefore be of great use when trying to accelerate a product’s time to market.

PREFILLED SYRINGES

Hideaki Kiminami

Terumo Pharmaceutical Solutions

DEVELOPMENT OF PREFILLABLE SYRINGES TO MITIGATE THE RISK OF PARTICLE FORMATION IN BIOPHARMACEUTICALS

Hideaki Kiminami and Philippe Lauwers discuss the problem of particle formation in biopharmaceuticals packaged in prefilled syringes.

PREFILLED SYRINGES

Mitsubishi Gas Chemical

MULTILAYER PLASTIC VIALS & SYRINGES FOR BIOLOGICS

Shota Arakawa and Tomohiro Suzuki discuss OXYCAPT™ Plastic Vial and Syringe, which provides a product with all the advantages of plastic, coupled with strong oxygen and UV barrier properties.

PREFILLED SYRINGES

UV STERILISATION & THE CASE FOR PREFILLED & PRELOADED DRUG DELIVERY SYSTEMS

Mindy Katz and Ori Ben-David review the different fill form configurations of drug delivery devices, outlining the importance of the prefilled and preloaded device configuration for self-administering patients.

THE ROAD TO PREFILLED DEVICES IN NOVEL COMBINATION PRODUCTS

Lior Shtram discusses three approaches to delivering novel combination products – user-filled, user-loaded and prefilled – through the lens of sterilisation processes and requirements at the industrial manufacturing scale.

PREFILLED SYRINGES

IMPROVING PATIENTS’ SELF-INJECTION EXPERIENCE

Jeff Lettman and Josh Hopkins explain how they worked with a client to develop a product that would function with the pre-existing drug delivery device to help rheumatoid arthritis patients with reduced dexterity.

PREFILLED SYRINGES

BD (Becton Dickinson & Company)

DRUG-DEVICE CO-PACKING SOLUTIONS TO ENHANCE DIFFERENTIATION AND IMPROVE EXPERIENCE

Janice Adkins discusses the benefits that co-packing, the practice of providing drug preparation and delivery systems along with a medication, can bring to pharmaceutical manufacturers, clinicians and patients.

SAFE, CONVENIENT AND EFFICIENT: INDIVIDUALISING PREFILLED SYRINGES

Ursula Hahn discusses the value of individualised prefilled syringes and explains how small changes in design or components can make a huge difference for doctors, patients and pharmaceutical manufacturers alike.

Charlotte Harvey

HOW SAFETY FEATURES MAKE OR BREAK INFUSION PUMP DESIGN

Charlotte Harvey and Tim Frearson overview the safety systems required when designing an infusion pump system, with a focus on free-flow prevention, occlusion detection and air-in-line detection.

BD (Becton Dickinson & Company)

ALICE MADEN & LIONEL MARITAN, BD MEDICAL – PHARMACEUTICAL SYSTEMS

Alice Maden and Lionel Maritan discuss with detailed expert knowledge the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems.

PREFILLED SYRINGES

Hans Peter Manser

LYCAJECT: AUTOMATIC RECONSTITUTION PATCH INJECTOR

Hans Peter Manser, Christoph Egloff and Martin C King introduce the LyCaJect Patch Injector, Weibel CDS’ offering in the field of wearable injectors, with automatic reconstitution as a headline feature.

PREFILLED SYRINGES

Florence Buscke

INNOVATIVE SOLUTIONS FOR PACKAGING BIOLOGICS

Florence Buscke, Nicolas Eon and Tom Van Ginneken outline SCHOTT’s offering across both glass and polymer primary containers for pharmaceuticals, emphasising their advantages in the rapidly growing biologics market.

TO SUBSTITUTE OR NOT TO SUBSTITUTE? THAT IS THE ANDA QUESTION

Natalie Shortt, Maija Smith and Venetia Dickinson discuss the US FDA’s Draft Guidance on how human factors relate to the ANDA process, and how its encouragement to stay close to the reference product may result in some negative consequences.

Napoleon Monroe

CONNECTIVITY USING CONSUMER TECHNOLOGY TO CREATE REAL VALUE FOR PATIENTS

Napoleon Monroe presents the case for the C-Container, a collective term for a theoretical class of consumer product designed to work with various drug delivery combination products.

CONFERENCE REVIEW

2018 UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES

In October 2018, the Universe of Pre-Filled Syringes and Injection Devices conference, organised by the Parenteral Drug Association (PDA), was held in Orlando, FL, US.

PREFILLED SYRINGES

Carina Van Eester

Datwlyer Sealing Solutions

DURA COAT COMBISEALS – DATWYLER’S NEXT GENERATION IN ALUMINIUM

Carina Van Eester covers the advantages presented by the company’s new abrasion-resistant material, Dura Coat, used for combiseals on cartridges.

Dr Gautam N Shetty

Congruence Medical Solutions

ACCURATE, PRECISE MICROLITRE DOSING WITH PREFILLABLE SYRINGES FOR OPHTHALMIC INJECTIONS

Gautam Shetty discusses the challenges inherent to delivering microlitre dosage volumes accurately from a standard prefilled syringe, and introduces Congruence’s Microlitre Dosing Syringe (MDS) platform as a solution.

INTRAVITREAL INJECTION OF VEGF INHIBITORS – IMPACT OF DRUG CONTAINERS

With the increasing use of intravitreal injections of vascular endothelial growth factor inhibitors in the treatment of numerous serious ocular diseases, Douglas Cusato provides a detailed comparative analysis of the issues at play.

Eric Dessertenne

SUCCESSFUL CONNECTED DEVICE DEVELOPMENT REQUIRES A ROBUST VALUE PROPOSITION

Eric Dessertenn discusses the current status of connectivity in healthcare, its future, benefits both in terms of addressing adherence and big data analysis, and emphasises the need for a robust business case.

PREFILLED SYRINGES

Dr Andreas Schneider

SIMPLE AND SECURE ADHERENCE MONITORING: YDS SMARTSERVICES™ FOR END-TO-END SMART DEVICE INTEGRATION

Whilst there is much discussion on how to apply connectivity and smart devices to therapies, there is far less dialogue concerning the challenges inherent to the digital architecture needed to make such innovations work in practice. Andreas Schneider introduces YDS SmartServices™, Ypsomed’s digital turnkey solution to effectively embed smart devices in a broader digital ecosystem.

PREFILLED SYRINGES

DEVELOPING DEMONSTRATORS TO INCREASE PATIENT CONFIDENCE AND REDUCE ANXIETY

Joe Reynolds discusses the value of demonstrators for making patients comfortable and effective with their prefilled syringe, leading to a significant improvement in treatment adherence and patient quality of life.

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