Devices
COATING TECHNOLOGY- Combining a State-of-the-Art Bromobutyl Formulation With a Proven ETFE Film for Exceptional Chemical Performance
Julie Suman, PhD, Sebastien Cordier, and Estelle Verger discuss the properties of the ETFE film coating technology used for PremiumCoat(R) vial stoppers and pre-filled syringe plungers. When combined with pure Bromobutyl formulation, the film forms a barrier that can reduce the number of leachables transferred into the solution, and their quantity by up to 98%.
CYBERSECURITY – Cybersecurity for Connected Medical Devices: A Holistic Approach During the Entire Product Lifecycle
Nicola Alagia explains why cybersecurity is important for connected medical devices and how to integrate ad hoc activities to tackle cybersecurity in the early phases of product development.
WHITE PAPER: Molly Modular Autoinjector Platform by SHL Medical
SHL Medical has redefined the conventional platform model by adding modularity to its proven Molly® autoinjector technology. This white paper outlines SHL’s predictive response to market imperatives in the….
INHALATION THERAPY – An Overview to Drug-Nebulizer Combination Development With Biologics
Hernan Cuevas Brun, MBA, says biologic drugs are increasingly being investigated for delivery with inhalation therapy, which has initiated more in-depth discussions about the implications of formulation development and their pairing with adequate inhaled devices for more efficient treatment outcomes.
DEVICE DEVELOPMENT – Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk
Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
SYRINGE PLUNGER – Exploring How the Functional Properties of the PremiumCoat® 1-3-mL Plunger Facilitate its Implementation on Filling Lines & Enable the Delivery of Sensitive Vaccines & Biotech Drugs
Sebastien Cordier, Laure-Hélène Guillemot, PhD, and Audrey Chardonnet explain how the PremiumCoat 1-3-mL syringe plunger combines a pure Bromobutyl formulation with a market-proven ETFE film that acts as a barrier to limit the transfer of rubber leachables into the drug product.
EXECUTIVE INTERVIEW – Emergent CDMO: Making the Impossible, Possible for Biopharma Innovators
Catherine Hanley, Vice President & Interim CDMO Business Unit Head at Emergent BioSolutions, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
HUMAN FACTORS STUDIES – Human Factors Studies During a Pandemic: How One Company Adapted to Covid-19 Restrictions
Miranda Newbery says although it is possible to carry out use risk assessments, expert reviews and device comparisons – which do not require contact with end users – these cannot fully replace first-hand user feedback.
CONNECTED DELIVERY – Five Perspectives on Connected Drug Delivery Devices
George I’ons offers insight into the factors driving the development and adoption of connected drug delivery devices and examines the varying perspectives held by relevant healthcare stakeholders.
DRUG DEVELOPMENT – Simplifying the Drug Development Journey
Fran DeGrazio explains how experienced and focused collaborators can provide guidance, support services, manpower, and intellect to make it easier to achieve all the goals needed in delivering a drug to a patient.
EXCLUSIVE ONLINE CONTENT
Lyra Therapeutics Announces Initiation of LYR-210 Pivotal Phase 3 ENLIGHTEN Program in Surgically Naïve Chronic Rhinosinusitis Patients
Lyra Therapeutics, Inc. recently announced the initiation of the Phase 3 ENLIGHTEN I clinical trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients, with trial sites open for….
Starton Therapeutics Successfully Demonstrates Continuous Drug Delivery of Lenalidomide From a Transdermal Patch in an In Vivo Nonclinical Study With STAR-LLD
Starton Therapeutics Inc. recently announced it successfully obtained promising results in a non-GLP rabbit pharmacokinetic (PK) and skin irritation study of….
Cocrystal Pharma’s COVID-19 Oral & Intranasal/Pulmonary Protease Inhibitors Exhibit Powerful In Vitro Potency Against the SARS-CoV-2 Omicron Variant
Cocrystal Pharma, Inc. recently announced in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main protease inhibitors exhibit antiviral potency against the Omicron variant…..
TFF Pharmaceuticals Announces Final Data From Phase 1b Study of Inhaled Voriconazole Powder in Asthma Patients
TFF Pharmaceuticals, Inc. recently announced the full readout of safety and pharmacokinetic (PK) data from its Phase 1b study (NCT #04576325) of Inhaled Voriconazole Powder (TFF VORI) in asthma patients….
PharmaTher Enters Process Development Agreement Eith LTS for Ketamine Microneedle Patch
PharmaTher Holdings Ltd. and LTS LOHMANN Therapie-Systeme AG recently announced they have entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary….