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Prefilled Syringes & Injection Devices156

Issue No #156 Jan 2024  January 17th, 2024


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Inside the magazine

HOW DIABESITY IS SHAPING THE WORLD OF SELF-INJECTION DEVICES
INJECTION
Ian Thompson
Ypsomed
HOW DIABESITY IS SHAPING THE WORLD OF SELF-INJECTION DEVICES
Ian Thompson takes us through the recent history of diabetes and obesity therapeutics, the innovative peptide hormone molecules that have reached the market over the past decades and the equally innovative devices developed to deliver them. He addresses the growing challenge of diabesity, and shows that diabetes and obesity will continue to influence self-injection device development substantially.
DRUG DELIVERY TRENDS FOR 2024
EXPERT VIEW
Tom Oakley
Springboard
DRUG DELIVERY TRENDS FOR 2024
Tom Oakley and Kamaal de Silva consider how keeping abreast of the latest trends can help the industry predict and prepare for the future and, commenting from Springboard's privileged position at the centre of many of the drug delivery sector’s most exciting developments, discuss the top trends to look out for in 2024.
FAST, STANDARD-COMPLIANT AND COST-EFFICIENT TESTING OF PREFILLED SYRINGES FOR OPTIMAL RESULTS
INJECTION
Peter Schmidt
ZwickRoell
FAST, STANDARD-COMPLIANT AND COST-EFFICIENT TESTING OF PREFILLED SYRINGES FOR OPTIMAL RESULTS
Peter Schmidt presents ZwickRoell’s solutions for testing autoinjectors and wearables to ensure a systematic increase in productivity in the testing lab.
NAVIGATING ISO 11608 WITH AUTOMATED EQUIPMENT FOR CUSTOMISED PEN AND AUTOINJECTOR TESTING
PREFILLED SYRINGES
Hisham Jamal
teamtechnik
NAVIGATING ISO 11608 WITH AUTOMATED EQUIPMENT FOR CUSTOMISED PEN AND AUTOINJECTOR TESTING
Hisham Jamal and Carsten Köhler discuss how teamtechnik’s automated testing machines – built on the foundation of assembly automation legacy – seamlessly align with the ISO 11608 regulations, effectively shaping the future of pen and autoinjector testing.
Interview with Lilli Zakarija, EdgeOne Medical
INTERVIEW
Lilli Zakarija
EdgeOne Medical
Interview with Lilli Zakarija, EdgeOne Medical
Lilli Zakarija talks with  Guy Furness about how EdgeOne Medical provides a critical service to companies undertaking drug delivery device development programmes, from small biotech start-ups all the way up to major pharmaceutical players. As part of this discussion, Ms Zakarija delves into the evolution of the drug delivery device industry over the past decades, some common pitfalls companies fall into during device development and what makes this sector such an exciting one to work in.
EXPLORING EXTRACTABLE AND LEACHABLE TESTING STRATEGIES FOR PARENTERALS
INJECTION
Antonio Scatena
Gateway Analytical
EXPLORING EXTRACTABLE AND LEACHABLE TESTING STRATEGIES FOR PARENTERALS
Antonio Scatena, Scott Toth and Kyle Chenevert  discuss the regulatory landscape regarding extractables and leachables for parenteral drugs and provide guidance on implementing a successful testing approach. Techniques and results interpretation are discussed, emphasising practical advice for developers working towards regulatory submission.
A NOVEL INSTRUMENT TO STREAMLINE COMBINATION PRODUCT DEVELOPMENT
INJECTION
Dr Daniel Primavessy
Midas Pharma
A NOVEL INSTRUMENT TO STREAMLINE COMBINATION PRODUCT DEVELOPMENT
Daniel Primavessy,  Sigrid Saaler-Reinhardt, Katarzyna Maksymowicz and Marie Stockton introduce the Gx Inbeneo® platform simulator. This tool supports pharmaceutical companies in bridging formulation and medical device development processes, reducing time to market for patient-centric combination products.
Interview with Alexandre Fontayne, Unither Pharmaceuticals
INTERVIEW
Alexandre Fontayne
Unither Pharmaceuticals
Interview with Alexandre Fontayne, Unither Pharmaceuticals
Guy Furness and Alexandre Fontayne discusses Unither Pharmaceuticals' EuroJect® injection device, based on the company’s extensive experience with blow-fill-seal technology. Mr Fontayne covers the advantages of EuroJect® compared with traditional glass syringes and multidose vials, as well as touching on where Unither sees EuroJect® having an impact in the market
AN ENABLING AUTOINJECTOR TECHNOLOGY FOR DELIVERY OF LONG-ACTING INJECTABLES
FORMULATION
Asmita Khanolkar
SMC Ltd
AN ENABLING AUTOINJECTOR TECHNOLOGY FOR DELIVERY OF LONG-ACTING INJECTABLES
Asmita Khanolkar and Susanna White explain why SMC Ltd's Vita autoinjector with resuspension technology provides a potential solution for the delivery challenges of long-acting injectables.
STAINLESS STEEL NEEDLES: QUANTIFYING COBALT RISK TO COMPLY WITH EU MEDICAL DEVICE REGULATION
PREFILLED SYRINGES
Dr Laura Berardi
Stevanato Group
STAINLESS STEEL NEEDLES: QUANTIFYING COBALT RISK TO COMPLY WITH EU MEDICAL DEVICE REGULATION
Laura Berardi discusses the reclassification of cobalt as a Category 1B carcinogen and presents a series of analytical studies into the toxicological risk present in needles and complete syringes.
SANTOPRENE<sup>®</sup> TPV – A NEXT STEP IN ELASTOMERIC COMPONENTS FOR CONVENTIONAL, SAFETY AND PREFILLED SYRINGES AND AUTOINJECTORS
PREFILLED SYRINGES
Shiva Douse
Celanese
SANTOPRENE® TPV – A NEXT STEP IN ELASTOMERIC COMPONENTS FOR CONVENTIONAL, SAFETY AND PREFILLED SYRINGES AND AUTOINJECTORS
Shiva Douse, Jeff Smith and Brad Wessman introduce Santoprene® TPV, a novel medical-grade thermoplastic elastomer for use in syringes and autoinjectors that offers significant benefits over traditional thermoset rubbers.
DELIVERY SOLUTIONS FOR DEEP-COLD DRUGS
PREFILLED SYRINGES
Tom Van Ginneken
SCHOTT Pharma
DELIVERY SOLUTIONS FOR DEEP-COLD DRUGS
Tom Van Ginneken considers how the growing pipeline of molecules that require cold storage has highlighted the need for better drug containment and delivery methods and highlights the potential SCHOTT TOPPAC® freeze syringes offer as a potential solution.
CONTAINER CLOSURE INTEGRITY OF OXYCAPT™ VIAL AT -80°C WITH DRY ICE
INJECTION
Hiroki Hasegawa
Mitsubishi Gas Chemical
CONTAINER CLOSURE INTEGRITY OF OXYCAPT™ VIAL AT -80°C WITH DRY ICE
Hiroki Hasegawa and Tomohiro Suzuki highlight the overall benefits of OXYCAPT, Mitsubishi Gas Chemical’s multilayer plastic vial, as a primary container for biologics and gene and cell therapies and discuss the company’s recent investigation into OXYCAPT’s performance at -80°C under dry ice conditions.
PRACTICAL PATHWAYS TO SUSTAINABILITY
SUSTAINABILITY
Alex Fong
Owen Mumford
PRACTICAL PATHWAYS TO SUSTAINABILITY
Alex Fong and Olivia Houselander discuss the importance of sustainability in the healthcare sector and the challenges that must be overcome to achieve it in a meaningful and lasting way.
DESIGNING FOR SUCCESS: CHOOSING THE RIGHT PRIMARY DRUG CONTAINER FOR PREFILLED DELIVERY DEVICES
INJECTION
Dr Brent Buchine
Windgap Medical
DESIGNING FOR SUCCESS: CHOOSING THE RIGHT PRIMARY DRUG CONTAINER FOR PREFILLED DELIVERY DEVICES
Brent Buchine and Jason Durkin reflect on the motivations and lessons from Windgap’s journey to design patient-centric, prefilled autoinjectors around custom and standard primary drug containers.
CAPA VALVE’S PATENTED TECHNOLOGY TRANSFORMS ANY SYRINGE INTO A DCD
EARLY INSIGHT
Dr Phil Green
Capa Valve
CAPA VALVE’S PATENTED TECHNOLOGY TRANSFORMS ANY SYRINGE INTO A DCD
Phil Green, Dale Charlton and Kevin Abbott introduce Capa Valve’s novel valve system for converting standard syringes into prefilled dual-chamber devices, capable of simplifying and improving the delivery of liquid-liquid and liquid-powder drug products, including reconstitution of lyophilised powders.
BEYOND THE POINT: NAVIGATING THE IMPACT OF NEEDLES ON PAIN, ANXIETY AND THE PATIENT EXPERIENCE
WEARABLES
Omar Rahman
Enable Injections
BEYOND THE POINT: NAVIGATING THE IMPACT OF NEEDLES ON PAIN, ANXIETY AND THE PATIENT EXPERIENCE
Omar Rahman, Mehul Desai and Keith Candiotti discuss the role that needle size plays in the pain and anxiety patients experience during injections and how smaller, hidden needles (30G), such as those employed by Enable Injections’ enFuse large-volume injector, may minimise patient discomfort and maximise subcutaneous injection efficiency.
FROM CONCEPT TO CURE: MASTERING LIQUID SILICONE RUBBER FOR MEDICAL DEVICE DESIGN
EXPERT VIEW
Kamaal de Silva
FROM CONCEPT TO CURE: MASTERING LIQUID SILICONE RUBBER FOR MEDICAL DEVICE DESIGN
Kamaal de Silva discusses the potential value of liquid silicone rubber in medical device design, including how its processing differs from other elastomers and how the challenges involved in its design and implementation can be overcome with specialist knowledge and experience.
DISCUSSION PRIMER: PHARMAPACK
PREFILLED SYRINGES
Alastair Willoughby
Team Consulting
DISCUSSION PRIMER: PHARMAPACK
Pharmapack’s organisers spoke with three industry experts, Alastair Willoughby, Jamie Greenwood and Chris Hurlstone, all from Team Consulting, to get their perspectives on the major trends expected to be top discussion topics at the event, and to play a significant role in the industry throughout 2024 and beyond.
KEY CONSIDERATIONS FOR SUCCESSFUL COMMERCIALISATION OF DRUG-DEVICE COMBINATION PRODUCTS
INJECTION
Bill Welch
PCI Pharma Services
KEY CONSIDERATIONS FOR SUCCESSFUL COMMERCIALISATION OF DRUG-DEVICE COMBINATION PRODUCTS
Bill Welch delves into the key considerations that stakeholders must address to ensure the successful commercialisation of drug-device combination products.
AN ECO-FRIENDLY AND ECONOMICAL APPROACH TO AUTOINJECTORS
EARLY INSIGHT
John Palmer-Felgate
Eco-inject
AN ECO-FRIENDLY AND ECONOMICAL APPROACH TO AUTOINJECTORS
John Palmer-Felgate introduces Eco-inject's patented innovation – a single-use, two-step autoinjector that is both eco-friendly and economical.
ADVANCING SUBCUTANEOUS DELIVERY OF BIOLOGICS: A NOVEL REUSABLE MEMS-ENABLED ACTUATOR
WEARABLES
Dr Hong-Jun Yeh
MicroMED Co Ltd
ADVANCING SUBCUTANEOUS DELIVERY OF BIOLOGICS: A NOVEL REUSABLE MEMS-ENABLED ACTUATOR
Hong-Jun Yeh, Jiunn-Ru Lai and Tsung-Chieh Cheng explore the challenges and opportunities related to the subcutaneous delivery of biotherapeutics. They also highlight a novel reusable MEMS-enabled pneumatic actuation system designed to overcome these challenges.
A SYMBIOTIC RELATIONSHIP BETWEEN DRUG DELIVERY DEVICE SYSTEMS AND PHARMA
INTERVIEW
Dr Troels Keldmann
A SYMBIOTIC RELATIONSHIP BETWEEN DRUG DELIVERY DEVICE SYSTEMS AND PHARMA
Troels Keldmann discusses the significance of the drug delivery industry, its relationship to pharma, the challenges it faces and how the pharma industry is shaping the drug delivery device field.
Vetter – A Leading Global CDMO for Aseptic Fill & Finish
VIDEO
Vetter Pharma
Vetter – A Leading Global CDMO for Aseptic Fill & Finish
Unlock the full potential of your injectable product. Vetter offers comprehensive fill-and-finish services from clinical development to commercialization and beyond. Watch the video here, and meet Vetter experts @ Pharmapack, booth H49, Paris, January 24-25, 2024.
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