Issue No #55
February 9th, 2015
Inside the magazine
Dr Jeannie Joughin
INTERVIEW: JEANNIE JOUGHIN, CSL BEHRING
Jeannie Joughin speaks exclusively with ONdrugDelivery Magazine about CSL Behring’s agreement with Enable, how it came about, what it means to the two companies, and how it’s going so far.
LEVERAGING NEEDS-CHARACTERISATION TO FUEL SMARTER DESIGN
Mark Tunkel and Craig Scherer discuss how needs-characterisation is becoming an essential part of combination product strategy in an increasingly competitive market.
Ludwig D Weibel
: FULL INTEGRATION OF ALL FUNCTIONS & PARTS, FULLY AUTOMATED RECONSTITUTION
Ludwig Weibel and Hans Peter Manser introduce the Reconstyringe
system, which offers a fully automated reconstitution of lyophilised drugs.
A STATE-OF-THE-ART HIGH-VOLUME MANUFACTURING LINE FOR A DISPOSABLE PEN PLATFORM PRODUCT
Tobias Nemeth outlines the advantages of platform product development and manufacture and goes on to describe the implementation of the UnoPen™ high-volume manufacturing line.
Dr Susan Dounce
Datwlyer Sealing Solutions
THE EVOLUTION OF FLUOROPOLYMER COATINGS FOR PARENTERAL PACKAGING
Susan M. Dounce describes how plunger coating has become about more than barrier properties.
Dr Andrea Behrenswerth
CRACK PREVENTION & PROCESS CONTROLS IN PREFILLABLE SYRINGE MANUFACTURING
Andrea Behrenswerth and Marc-Oliver Luther both of Gerresheimer Bünde, and Bernhard Hinsch of Hinsch Consulting (Hamburg, Germany), explain the most frequently encountered types of defects, their causes and specific approaches to process optimisation.
Anastasie Formey de Saint Louvent
BD (Becton Dickinson & Company)
HUMAN FACTORS ENGINEERING, COMBINATION PRODUCT REGULATION AND INNOVATIVE SAFETY SYSTEMS
Sarah Malka and Anastasie Formey de Saint Louvent describe how BD integrates human factors engineering and patient-centric design into an innovative partnering model for the development of new products.
OMPI NEXA SYRINGES: THE IDEAL SOLUTION FOR THE MOST DEMANDING DRUGS
Alessandro Morandotti introduce the Ompi Nexa Syringe, and describe in detail how its design fulfills the challenging quality requirements for prefilled syringes used for the storage and delivery of biological molecules.
CREDENCE MEDSYSTEMS & THE CREDENCE COMPANION SAFETY SYRINGE SYSTEM
John A Merhige summarises the Credence Companion Safety Syringe System, and how it fits with the company’s core philosophy of Innovation Without Change for the benefit of biopharmaceutical partners.
Terumo Pharmaceutical Solutions
USING PREFILLABLE SYRINGES FOR BIOPHARMACEUTICALS – DEVELOPMENT & CHALLENGES
William Dierick and Keisuke Yoshino describe the development of Terumo’s PLAJEXTM prefillable syringe system, which combines specific features of a COP syringe with the proprietary i-coatingTM technology to create a silicone oil-free system.
Dr Nicolas Brandes
West Pharmaceutical Services
FOUR WAYS POLYMERS TRUMP GLASS FOR CONTAINING CUTTING-EDGE INJECTABLE BIOLOGICS
Nicolas Brandes makes the case that polymers offer superior benefits compared with glass as a material for primary containers and delivery systems for parenteral drugs, including in particular biologics.
COMPANY SHOWCASE: PHILLIPS-MEDISIZE
Phillips-Medisize is a global-leader in outsource design, development and technology-driven manufacturing.
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