Delivering Injectables: Devices & Formulations 160

Issue No #160 May 2024 May 31st, 2024

Inside the magazine

CHALLENGES IN TESTING THE ACCURACY OF INFUSION PUMP DOSES

CHALLENGES IN TESTING THE ACCURACY OF INFUSION PUMP DOSES

Lucas Foerster and Dieter Peissig explore the critical factors in choosing the right balance for infusion pump performance validation and discuss potential sources of error.

SHL MOLLY<sup>®</sup> AUTOINJECTORS: POWERING THE NEXT WAVE OF CARDIOMETABOLIC CARE

SHL MOLLY^® AUTOINJECTORS: POWERING THE NEXT WAVE OF CARDIOMETABOLIC CARE

Lars Berger and Eric Linvill discuss the rapid growth of the cardiometabolic disease space in light of the global obesity epidemic and how advanced autoinjector and injection pen technologies, such as SHL Medical’s Molly platform, will be necessary to meet the challenges presented by this disease area.

PACKAGING MATERIAL IDENTIFICATION TO ENSURE SELECTION OF BEST-MATCHING COMPONENTS FOR PARENTERAL DRUGS

Dr Uwe Rothhaar

PACKAGING MATERIAL IDENTIFICATION TO ENSURE SELECTION OF BEST-MATCHING COMPONENTS FOR PARENTERAL DRUGS

Uwe Rothhaar, Daniel Haines, Matthias Bicker and Thomas Schmidt discuss the analytical techniques used to identify the material components and composition of primary containers for injectable drug products.

VIAL STOPPER COMPATIBILITY: CRITERIA AND TESTING METHODS FOR PHARMACEUTICAL PACKAGING

Dr Laure-Helene Guillemot

VIAL STOPPER COMPATIBILITY: CRITERIA AND TESTING METHODS FOR PHARMACEUTICAL PACKAGING

Laure-Hélène Guillemot, Benjamin Brocco, Edouard Pagnoud and Pascal Sircoulomb, discuss some of the key parameters to consider when choosing a vial stopper and present evaluation methods that were developed to test and demonstrate the compatibility of various stoppers with commonly used vial designs.

OXYCAPT VIAL’S CONTAINER CLOSURE INTEGRITY AT -80°C WITH DRY ICE AND CO<sub>2</sub> BARRIER

Mitsubishi Gas Chemical

OXYCAPT VIAL’S CONTAINER CLOSURE INTEGRITY AT -80°C WITH DRY ICE AND CO₂ BARRIER

Masashi Miura and Tomohiro Suzuki, discuss the beneficial features of the OXYCAPT™ multilayer vial for biologics and gene and cell therapies, sharing recent study results highlighting OXYCAPT’s performance at -80°C under dry-ice conditions and its high carbon dioxide barrier compared with standard cyclo-olefin polymer.

THE CHALLENGES OF DEVELOPING DRUG DELIVERY DEVICES FOR THE JAPANESE MARKET

Olivia Houselander

THE CHALLENGES OF DEVELOPING DRUG DELIVERY DEVICES FOR THE JAPANESE MARKET

Olivia Houselander outlines some of the challenges of developing drug delivery devices for the Japanese market and shares details of Owen Mumford’s latest two products to gain approval in Japan.

NAVIGATING THE TRANSITION FROM MDD TO MDR FOR CO-PACKAGED COMBINATION PRODUCTS

West Pharmaceutical Services

NAVIGATING THE TRANSITION FROM MDD TO MDR FOR CO-PACKAGED COMBINATION PRODUCTS

Paul Scannell explains how to safely navigate the regulatory landscape for co-packaged drug-device combination products.

THROUGH THICK AND THIN: MODELLING THE DELIVERY OF NON-NEWTONIAN FORMULATIONS

THROUGH THICK AND THIN: MODELLING THE DELIVERY OF NON-NEWTONIAN FORMULATIONS

Alex Vasiev explores the challenges inherent in understanding flow rates in injectable drug delivery when dealing with non-Newtonian fluids, and provides an overview of how to calculate flow rates for power law, Carreau and Cross fluids.

DELIVERING ON GLP-1 DEMAND: A COMBINATION OF DEVICE OFFERINGS AND SUPPLY STRATEGY

Stevanato Group

DELIVERING ON GLP-1 DEMAND: A COMBINATION OF DEVICE OFFERINGS AND SUPPLY STRATEGY

Manuela Giacon and Josh Gordon, review the growth in demand for glucagon-like peptide-1 treatments and present Stevanato Group's response to this exciting opportunity, showcasing its Alina^® device platform for pen injectors and the Aidaptus^® two-step, single-use autoinjector.

ADDRESSING DIABESITY WITH PEN INJECTOR PLATFORMS

ADDRESSING DIABESITY WITH PEN INJECTOR PLATFORMS

Cécile Gross and Mark Tunkel discuss the variety of pen injector platforms to meet the different needs of diabetes patients.

COMPANY SHOWCASE: VETTER PHARMA

COMPANY SHOWCASE: VETTER PHARMA

Vetter is a CDMO that offers services for pharma and biotech firms of all sizes and locations and holds numerous patents, including technologies for protection against tampering and counterfeiting. Its expertise ranges from lyophilisation (freeze-drying) to siliconisation and more.

HOW DO YOU PERCEIVE INTRADERMAL DELIVERY? THINK AGAIN…

Dr Nicky Bertollo

HOW DO YOU PERCEIVE INTRADERMAL DELIVERY? THINK AGAIN…

Nicky Bertollo, Adam Rock and Ronan Byrne discuss the benefits and limitations of intradermal delivery – and introduce the Pharma Latch Hollow intradermal injection device.

ACCELERATING INNOVATION: THE POWER OF PARALLEL DEVELOPMENT FOR AN AUTOINJECTOR LAUNCH

PCI Pharma Services

ACCELERATING INNOVATION: THE POWER OF PARALLEL DEVELOPMENT FOR AN AUTOINJECTOR LAUNCH

Jeff Clement and Bill Welch explore the essential considerations for navigating the parallel development of a drug product in a vial and a prefilled syringe for an autoinjector, together with the downstream final assembly and pack considerations, from early-phase clinical trials to commercialisation.

ACCELERATING COMBINATION PRODUCT DEVELOPMENT USING DIGITAL TWIN TECHNOLOGY

ACCELERATING COMBINATION PRODUCT DEVELOPMENT USING DIGITAL TWIN TECHNOLOGY

Dan Cowen, Sebastian White and Anthony Robinson, discuss the value that implementing a digital twin could provide to drug delivery device design across multiple stages of a development programme.

TRANSITIONING FROM VIAL TO SUBCUTANEOUS INJECTION DEVICES FOR BIOLOGICAL DRUG PRODUCTS

Dr Michael Adler

TRANSITIONING FROM VIAL TO SUBCUTANEOUS INJECTION DEVICES FOR BIOLOGICAL DRUG PRODUCTS

Michael Adler, Venkata Appa Reddy Goli, Andrea Allmendinger and Hanns-Christian Mahler, discuss the various factors that need to be considered when transferring to a delivery device for subcutaneous injection, such as a prefilled syringe or autoinjector, during clinical trials or post-launch, especially when transferring from a vial format for intravenous infusion.

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