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.
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.
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.
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.
SPECIAL FEATURE – Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
DELIVERY DEVICE – Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways
Degenhard Marx, PhD, Fotos Stylianou, PhD, and Stavros Kassinos, PhD, explain how PureHale provides a modern device option for the delivery of a fine mist for a variety of solutions to only the upper respiratory tract without significant deposition in the lungs and lower airways.
NASAL SPRAY BIOEQUIVALENCE – Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
Sebastien Cordier, Bruno Morchain, and Estelle Verger review how PremiumCoat combines state-of-the art elastomer formulation with market-proven film-coating technology to create a highly advanced stopper solution.
EXCLUSIVE ONLINE CONTENT
Sever Pharma Solutions (SPS) recently announced it has entered into a definitive agreement to acquire the assets of Foster Delivery Science (FDS) located in Putnam, CT…..
Baxter Announced $100-Million Investment in BioPharma Solutions Halle/Westfalen, Germany Sterile Fill/Finish Manufacturing Facility
Baxter International Inc. recently announced an approximately $100-million expansion of its sterile fill/finish manufacturing facility located in Halle/Westfalen, Germany. This facility is….
Gerresheimer recently announced it has acquired the IP of a new generation cartridge-based autoinjector from Midas Pharma. This is the start of a strategic partnership. The joint project comprises the development and marketing of the new generation autoinjector…
Nemera has a proven track record in developing and manufacturing complex Ear Nose and Throat solutions. In line with clear growing market interest in unidose system coupled with promising advantages that nasal route could….
Inari Medical Announces Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever System in Pulmonary Embolism Patients
Inari Medical, Inc. recently announced planned enrollment of the PEERLESS trial. PEERLESS is a new randomized controlled trial (RCT) comparing the clinical outcomes of patients with intermediate-high risk pulmonary embolism….