Prefilled Syringes & Injection Devices79

Issue No #79 October 16th, 2017

Inside the magazine

A NEW VALUE PROPOSITION OF SMART DEVICES: ADVANCED MEDICATION ADHERENCE MONITORING IN CLINICAL TRIALS

PREFILLED SYRINGES

Dr Andreas Schneider

A NEW VALUE PROPOSITION OF SMART DEVICES: ADVANCED MEDICATION ADHERENCE MONITORING IN CLINICAL TRIALS

Andreas Schneider explores a new value proposition of smart injection systems, introducing how advanced adherence monitoring services resolve some of the key challenges of clinical research practice regarding costs, adherence, data quality and integrity, Dr Schneider explains which technical features are needed for smart devices to provide value-adding adherence monitoring services, using SmartPilot for YpsoMate as a case study.

PRODUCT SHOWCASE: APTAR PHARMA’S PREMIUM PORTFOLIO

PREFILLED SYRINGES

Arnaud Fournier

PRODUCT SHOWCASE: APTAR PHARMA’S PREMIUM PORTFOLIO

For over 50 years Aptar Pharma’s injectables specialists have led the way in developing innovative elastomer solutions. Their commitment to continuous improvement has resulted in elastomer formulations that feature best-in-class extractables and leachables profiles.

DEVELOPING DEMONSTRATORS TO INCREASE PATIENT CONFIDENCE & REDUCE ANXIETY

PREFILLED SYRINGES

DEVELOPING DEMONSTRATORS TO INCREASE PATIENT CONFIDENCE & REDUCE ANXIETY

Using Noble’s recent partnership with BD to develop trainers for BD’s UltraSafe™ needle safety technology as an example, Joe Reynolds discusses the importance of training devices for the successful onboarding of patients beginning to use self-injected therapeutics, and how Noble’s training devices are designed to be faithful to the look and feel of the real product.

A REVIEW OF REUSABLE AUTO-INJECTORS FOR BIOLOGICAL & BIOSIMILAR DRUGS

PREFILLED SYRINGES

Dr Menachem Zucker

E3D – Elcam Drug Delivery Devices

A REVIEW OF REUSABLE AUTO-INJECTORS FOR BIOLOGICAL & BIOSIMILAR DRUGS

From the perspective of the growing biologics and emerging biosimilars markets, Menachem Zucker showcases E3D – Elcam Drug Delivery Devices' mechanical and electronic auto-injector platforms, both of which are reusable devices with disposable cassettes.

DOES THE NEW EU MDR SPELL THE END OF GRANDFATHERING?

DOES THE NEW EU MDR SPELL THE END OF GRANDFATHERING?

Helen Simons and Stephanie Ward describe how the new EU Medical Devices Regulation will impact on “grandfathered” devices that were approved under old regulation and are currently on the market, but do not necessarily comply with current/updated regulatory standards, and explain the potential implications for device manufacturers.

THE VALUE OF A BD INTEGRATED SYSTEM FOR COMBINATION PRODUCTS

PREFILLED SYRINGES

Dr Theresa Bankston

BD (Becton Dickinson & Company)

THE VALUE OF A BD INTEGRATED SYSTEM FOR COMBINATION PRODUCTS

Theresa Bankston looks at the advantages of using an integrated system for drug-device combination products. As well as avoiding problems such as breakage and incompatibility, integrated products can offer solutions at every interface between the drug, container and delivery device and save significant amounts of time and money.

THE UNIVERSE OF PRE-FILLED SYRINGES & INJECTION DEVICES

CONFERENCE SHOWCASE

Dr Georg Roessling

THE UNIVERSE OF PRE-FILLED SYRINGES & INJECTION DEVICES

This year’s Universe of Pre-filled Syringes and Injection Devices will examine increasingly important issues, such as the new patient-centric business reality for the self-injection market and rising US FDA concerns about self-injection.

TORSTEN MASCHKE, DATWYLER SEALING SOLUTIONS

Torsten Maschke

TORSTEN MASCHKE, DATWYLER SEALING SOLUTIONS

Torsten Maschke has been Chief Executive of the Sealing Solutions division of Datwyler and a member of the group’s Executive Board since October 2016. Before joining Datwyler Group, he was responsible for the worldwide distribution of sealing and damping solutions for the automotive industry at Freudenberg Group (Weinheim, Germany).

UNISAFE<sup>®</sup>: THE IMPORTANCE OF ROBUST DESIGN PREDICTIONS IN DEVICE MANUFACTURING

PREFILLED SYRINGES

UNISAFE^®: THE IMPORTANCE OF ROBUST DESIGN PREDICTIONS IN DEVICE MANUFACTURING

Damian Holland outlines how the design team went about creating a safer and user-friendly springless safety syringe – UniSafe^® – which bypasses some of the problems associated with spring-based devices.

PROFITABLE PACKAGING & MODULAR THINKING FOR INDUSTRY 4.0

PREFILLED SYRINGES

Christoph Hammer

PROFITABLE PACKAGING & MODULAR THINKING FOR INDUSTRY 4.0

Christoph Hammer discusses the financial reasoning behind the selection of packaging equipment, taking into account real current and potential future requirements (paying particular attention to Industry 4.0 concepts), and highlighting the advantages of taking a modular approach, such as the solutions offered by Dividella and its sister companies.

THE MAKINGS OF INNOVATION IN ADVANCED DRUG DELIVERY

PREFILLED SYRINGES

THE MAKINGS OF INNOVATION IN ADVANCED DRUG DELIVERY

In the context of recent industry trends and market demands, including the emergence of biosimilars and increasingly viscous formulations, SHL provides an update on its portfolio of auto-injector products, including two new devices, Maggie® and Bertha™.

NEWGUARD – PAVING THE WAY FOR A NEW SAFETY STANDARD

PREFILLED SYRINGES

Philippe Lesaulnier

NEWGUARD – PAVING THE WAY FOR A NEW SAFETY STANDARD

Needlestick injuries remain a serious concern for pharmaceutical companies involved in injectable drugs. Biocorp has been developing NewGuard™, an integrated passive safety device to tackle this problem. Throughout the development phase, Biocorp defined key elements to ensure NewGuard™ will not require unnecessary changes to be made to the PFS manufacturing process. Philippe Lesaulnier and Eric Dessertenne explain more.

CRITICAL MATERIAL CONSIDERATIONS FOR DRUG CONTAINMENT

PREFILLED SYRINGES

Specialty Coating Systems

CRITICAL MATERIAL CONSIDERATIONS FOR DRUG CONTAINMENT

Dick Molin highlights some of the hazards that arise through the use of traditional lubricious coatings in parenteral delivery devices. Particular focus is paid to the problems of protein aggregation and trace impurities leaching from elastomeric components before describing how the polymer Parylene, applied as a very thin coating using SCS’ unique deposition method, avoids them.

STEVEN R KAUFMAN, BESPAK

STEVEN R KAUFMAN, BESPAK

Steven Kaufman is Global Business Development Lead at Bespak Europe Ltd, responsible for business development activities related to injectable devices such as auto-injectors and wearable injection systems.

USING POLYMERIC PDC TECHNOLOGY TO IMPROVE AUTO-INJECTOR DESIGN

PREFILLED SYRINGES

Jonathan Lawson

Oval Medical Technologies

USING POLYMERIC PDC TECHNOLOGY TO IMPROVE AUTO-INJECTOR DESIGN

The limitations of using glass-based auto-injectors, such as contamination, and the need for delivering complex, viscous preparations, have led to a new approach that uses polymeric PDC technology instead. Jonathan Lawson, Jonathan Bradshaw and Susie White look at what polymeric PDCs can offer in making auto-injectors truly patient-centric.

DESIGN VALIDATION TESTING – DRUG DELIVERY DEVICES

DESIGN VALIDATION TESTING – DRUG DELIVERY DEVICES

From a regulatory perspective, Mark Turner provides a summary of the current requirements of parenteral device manufacturers in the area of design validation testing.

COMPLEX DEVICES, SIMPLE PATIENT CARE

PREFILLED SYRINGES

Adrien Tisserand

COMPLEX DEVICES, SIMPLE PATIENT CARE

Adrien Tisserand explains how the recent granting of German Pharmaceutical Drug Manufacturing Authorisation for Nemera’s facility in Neuenburg enhances the company’s offering to industry, before going on to discuss the Safelia^® auto-injector and Safe’n’Sound^® safety device platforms.