Delivering Injectables: Devices & Formulations 147

Issue No #147 May 2023 May 21st, 2023

Inside the magazine

COLD STORAGE AND CONTAINER CLOSURE INTEGRITY – DEMONSTRATED PERFORMANCE OF ETFE-COATED COMPONENTS

Sebastien Cordier

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

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

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

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

Dr Andreas Schneider

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

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

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

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

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

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

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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