Issue No #95
February 4th, 2019
Inside the magazine
SOLUTIONS FOR HIGH-VOLUME DRUG DELIVERY
SHL Group introduces the high-volume variation of its Molly
family of products, the Molly
2.25, and discusses more broadly the advantages that the Molly
business model offers to pharmaceutical and biotech clients.
TECHNOLOGY SHOWCASE: teamtechnik’s LED Cannula Gluing Process
Ingo Stephan introduces a new gluing process for attaching cannulas using LEDs from teamtechnik.
PCI Pharma Services
BIOLOGIC MEDICINES AND PATIENT-CENTRICITY – A NEW PHASE OF HOPE
Justin Schroeder discusses how the increasing biologics and biosimilars market has driven innovation and a trend towards self-administration and user-centricity in the injectable drug delivery device market.
BD (Becton Dickinson & Company)
SAGAR BEJALWAR, BD MEDICAL – PHARMACEUTICAL SYSTEMS
Sagar Bejalwar discusses the product and clinician needs in delivering hyaluronic acid for cosmetic applications.
HAZARDOUS DRUG HANDLING AND INVESTIGATIONAL DRUGS: LESSONS TO LEARN
Marino Kriheli discusses the need for closed-system transfer devices when handling hazardous drugs, particularly as they relate to investigational drugs, not only as key to patient and healthcare practitioner safety, but also in the context of upcoming US regulation.
Dr Eric Chappel
LOW-COST DISPOSABLE WEARABLE INJECTOR PLATFORM FOR LARGE VOLUMES OF VISCOUS DRUGS
Eric Chappel, Dimitry Dumont-Fillon and Laurent-Dominique Piveteau discuss Debiotech’s novel wearable injector technology, which utilises a propellant vapour system to drive the injection, making the device both space- and cost-efficient.
SIX TECHNIQUES FOR RAPID EARLY-STAGE MEDICAL DEVICE DEVELOPMENT
Stuart Curtis runs through six techniques which, in his experience, are invaluable for accelerating the early development stages of drug delivery device design and can therefore be of great use when trying to accelerate a product’s time to market.
Terumo Pharmaceutical Solutions
DEVELOPMENT OF PREFILLABLE SYRINGES TO MITIGATE THE RISK OF PARTICLE FORMATION IN BIOPHARMACEUTICALS
Hideaki Kiminami and Philippe Lauwers discuss the problem of particle formation in biopharmaceuticals packaged in prefilled syringes.
Mitsubishi Gas Chemical
MULTILAYER PLASTIC VIALS & SYRINGES FOR BIOLOGICS
Shota Arakawa and Tomohiro Suzuki discuss OXYCAPT™ Plastic Vial and Syringe, which provides a product with all the advantages of plastic, coupled with strong oxygen and UV barrier properties.
UV STERILISATION & THE CASE FOR PREFILLED & PRELOADED DRUG DELIVERY SYSTEMS
Mindy Katz and Ori Ben-David review the different fill form configurations of drug delivery devices, outlining the importance of the prefilled and preloaded device configuration for self-administering patients.
THE ROAD TO PREFILLED DEVICES IN NOVEL COMBINATION PRODUCTS
Lior Shtram discusses three approaches to delivering novel combination products – user-filled, user-loaded and prefilled – through the lens of sterilisation processes and requirements at the industrial manufacturing scale.
IMPROVING PATIENTS’ SELF-INJECTION EXPERIENCE
Jeff Lettman and Josh Hopkins explain how they worked with a client to develop a product that would function with the pre-existing drug delivery device to help rheumatoid arthritis patients with reduced dexterity.
BD (Becton Dickinson & Company)
DRUG-DEVICE CO-PACKING SOLUTIONS TO ENHANCE DIFFERENTIATION AND IMPROVE EXPERIENCE
Janice Adkins discusses the benefits that co-packing, the practice of providing drug preparation and delivery systems along with a medication, can bring to pharmaceutical manufacturers, clinicians and patients.
SAFE, CONVENIENT AND EFFICIENT: INDIVIDUALISING PREFILLED SYRINGES
Ursula Hahn discusses the value of individualised prefilled syringes and explains how small changes in design or components can make a huge difference for doctors, patients and pharmaceutical manufacturers alike.
HOW SAFETY FEATURES MAKE OR BREAK INFUSION PUMP DESIGN
Charlotte Harvey and Tim Frearson overview the safety systems required when designing an infusion pump system, with a focus on free-flow prevention, occlusion detection and air-in-line detection.
Dr Alice Maden
BD (Becton Dickinson & Company)
ALICE MADEN & LIONEL MARITAN, BD MEDICAL – PHARMACEUTICAL SYSTEMS
Alice Maden and Lionel Maritan discuss with detailed expert knowledge the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems.
Hans Peter Manser
LYCAJECT: AUTOMATIC RECONSTITUTION PATCH INJECTOR
Hans Peter Manser, Christoph Egloff and Martin C King introduce the LyCaJect Patch Injector, Weibel CDS’ offering in the field of wearable injectors, with automatic reconstitution as a headline feature.
TO SUBSTITUTE OR NOT TO SUBSTITUTE? THAT IS THE ANDA QUESTION
Natalie Shortt, Maija Smith and Venetia Dickinson discuss the US FDA’s Draft Guidance on how human factors relate to the ANDA process, and how its encouragement to stay close to the reference product may result in some negative consequences.
INNOVATIVE SOLUTIONS FOR PACKAGING BIOLOGICS
Florence Buscke, Nicolas Eon and Tom Van Ginneken outline SCHOTT’s offering across both glass and polymer primary containers for pharmaceuticals, emphasising their advantages in the rapidly growing biologics market.
CONNECTIVITY USING CONSUMER TECHNOLOGY TO CREATE REAL VALUE FOR PATIENTS
Napoleon Monroe presents the case for the C-Container, a collective term for a theoretical class of consumer product designed to work with various drug delivery combination products.
Carina Van Eester
Datwlyer Sealing Solutions
DURA COAT COMBISEALS – DATWYLER’S NEXT GENERATION IN ALUMINIUM
Carina Van Eester covers the advantages presented by the company’s new abrasion-resistant material, Dura Coat, used for combiseals on cartridges.
2018 UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES
In October 2018, the Universe of Pre-Filled Syringes and Injection Devices conference, organised by the Parenteral Drug Association (PDA), was held in Orlando, FL, US.
FROM GRANULATE TO PACKAGED PRODUCT
ZAHORANSKY runs through the options and advantages conferred by Z.BLIZZARD and its other automation technologies, with further explanations from Berthold Schopferer.
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