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.
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).
EXCLUSIVE ONLINE CONTENT
Molex Expands European Manufacturing Footprint & Capabilities With State-of-the-Art Campus in Poland
Molex recently announced a major expansion of its global manufacturing footprint with the opening of a new campus in Katowice, Poland. The facility’s initial 23,000-square-meter manufacturing space will….
In just the last few years, the shift toward at-home, self-administered care has become one of the defining trends in the global market for injectable therapies…..
With its borosilicate glass being the gold standard for storing life-saving medications for more than a century, the company is now taking the next steps by introducing improved glass tubing to the global pharma market…..
Datwyler Introduces Ready-for-Sterilization Combiseals to Enhance Efficiency in Drug Filling & Packaging
Ready-for-sterilization (RFS) combiseals for cartridges take the burden off drug manufacturers to prep packaging components for sterilization, saving time and cost while complying with FDA and EU regulations…..
Vetter recently announced additional investments as part of its long-term dedication to customer partnerships. Vetter’s extensive 40+ years of experience in aseptic filling and packaging shows a consistent desire for sustainable growth and corporate development…..
MARKET NEWS & TRENDS
The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices….
As the advantages of transdermal drug delivery grow, the global market for transdermal patches also is growing. Join DuPont™ Liveo™ Healthcare Solutions and Gattefossé Pharmaceuticals for a complimentary one-hour webinar to explore the current….
On Demand Webinar – Emergent CDMO: High-Speed Manufacturing Solutions for Your Viral Vaccine or Therapeutic
Emergent and groniger partner to present the benefits and features of the INTEGRA® high-speed aseptic fill line with isolator technology for viral vaccines and therapeutics.
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly…
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
Are you prepared for the HFA phasedown? With many industries switching to more environmentally friendly propellants, pMDI developers need to be ready. Recipharm explore alternative…
White Paper: A Systematic Review of Molly’s Integrated and Flexible Device Design and Development Model SHL Medical has redefined the conventional platform model by…