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Delivering Injectables: Devices & Formulations 147

Issue No #147 May 2023  May 21st, 2023


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Issue 147 - May 2023

Inside the magazine

COLD STORAGE AND CONTAINER CLOSURE INTEGRITY – DEMONSTRATED PERFORMANCE OF ETFE-COATED COMPONENTS
INJECTION
Sebastien Cordier
Aptar Pharma
COLD STORAGE AND CONTAINER CLOSURE INTEGRITY – DEMONSTRATED PERFORMANCE OF ETFE-COATED COMPONENTS
Sebastien Cordier; Benjamin Brocco; Estelle Verger and Arnaud Clausse discuss the results of a series of tests to demonstrate that PremiumCoat® can maintain closure integrity down to -80°C.
ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS
EXPERT VIEW
Timothy Bubb
ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS
Timothy Bubb discusses the five steps to setting up an effective post-market surveillance process.
INTEGRATED DRUG PRODUCT DEVELOPMENT AND MANUFACTURING
INDUSTRIALISATION
Dr Andrea Allmendinger
ten23 health
INTEGRATED DRUG PRODUCT DEVELOPMENT AND MANUFACTURING
Andrea Allmendinger; Michael Adler and Hanns-Christian Mahler highlight the importance of integrated drug product development, considering aspects such as formulation, device, container closure system, manufacturing processes and usability, as well as considering the quality target product profile and clinical phase-appropriate technical development strategy.
DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS
EXPERT VIEW
Thomas James
DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS
Thomas James highlights the importance of early user engagement, as well as continuous refinement of information and workflow design, for efficient development of drug-device combination products for emergency use.
HOW PATIENT & TREATMENT FACTORS SHAPE SUBCUTANEOUS DOSING PREFERENCES
INJECTION
Dr Andreas Schneider
Ypsomed
HOW PATIENT & TREATMENT FACTORS SHAPE SUBCUTANEOUS DOSING PREFERENCES
Andreas Schneider highlights the importance of understanding the drivers of dosing preferences when it comes to choosing the right injection device for patients. Specifically, the research summarised here studies whether and how patient characteristics and treatment attributes influence the decision to use prefilled handheld autoinjectors or large-volume wearable injectors.
TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS
EXPERT VIEW
John Burke
TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS
John Burke considers the challenges that manufacturers need to overcome when designing emergency-use autoinjectors.
HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT
CONNECTIVITY
Finola Austin
Owen Mumford
HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT
Finola Austin looks at the role human factors testing plays in the development of connected drug delivery devices.
ADDRESSING PEPTIDE THERAPEUTICS WITH A VERSATILE PEN PLATFORM
INJECTION
Cecile Gross
Nemera
ADDRESSING PEPTIDE THERAPEUTICS WITH A VERSATILE PEN PLATFORM
Cécile Gross and Mark Tunkel discuss the rising demand in peptide therapeutics and how Nemera’s PenVario pen injector platform, coupled with Nemera’s end-to-end service offering, has been designed to help pharma partners achieve success in this sector.
STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS
EXPERT VIEW
Deepu Asok
STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS
Deepu Asok discusses the importance of test method validation for drug-device combination product development and how a common mistake is to design the validation process for a specific device rather than to accommodate the potential variety of a device platform.
OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES
INJECTION
Tomohiro Suzuki
Mitsubishi Gas Chemical
OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES
Tomohiro Suzuki reviews the advantages that OXYCAPT™, Mitsubishi Gas Chemical's multilayer material for vials, offers to biologics and gene and cell therapies, and discusses the results of recent tests into low-temperature storage and dimethyl sulfoxide resistance.
MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES
EXPERT VIEW
Eugene Polini
MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES
Eugene Polini discusses the importance of container closure for the parenteral drug market, including some of the consequences of compromised container closure and what steps manufacturers can take to ensure that primary packaging systems remain sealed for a product’s entire shelf life.
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