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PREFILLED SYRINGES

AUTOMATING ASSEMBLY TO EXPEDITE TIME-TO-MARKET
INDUSTRIALISATION
Dr Dave Seaward
3P Innovation
AUTOMATING ASSEMBLY TO EXPEDITE TIME-TO-MARKET
Dave Seaward discusses how 3P innovation takes a holistic approach to solving the technical challenges encountered by its clients and looks for opportunities to enhance the final product, enable efficient processing and support commercially viable manufacturing.
TERUMO GLOBAL PARENTERAL CDMO – INTEGRATED INNOVATION
INDUSTRIALISATION
Michele Guasti
Terumo Medical Care Solutions
TERUMO GLOBAL PARENTERAL CDMO – INTEGRATED INNOVATION
Michele Guasti discusses the advantages that Terumo’s parenteral CDMO brings to customers due to its position as a single service provider from formulation to final product and its intimate understanding of Terumo’s range of prefillable polymer syringes.
COMPANY SHOWCASE: PCI PHARMA SERVICES
INDUSTRIALISATION
PCI Pharma Services
COMPANY SHOWCASE: PCI PHARMA SERVICES
PCI Pharma Services showcases its portfolio of drug delivery-relevant solutions, including: sterile fill-finish and lyophilisation; drug-device combination product design and development; packaging for injectables; and Speedsolutions™ supply chain simplification, and highlights plans for expansion.
INTERVIEW: DOUG BRYANS, BRYLLAN & JOHN MERHIGE, CREDENCE
INTERVIEW
Dr Doug Bryans
Bryllan
INTERVIEW: DOUG BRYANS, BRYLLAN & JOHN MERHIGE, CREDENCE
Douglas Bryans and John Merhige discuss the changing needs of drug developers around novel dual-chamber and ready-to-use drug delivery devices, capacity and the delivery of complete solutions from CDMOs and device developers, anchored around the recently announced partnership between Credence MedSystems and Bryllan to provide these critical services.
NEW EXTRACTABLES DATA FOR OXYCAPT™ MULTILAYER PLASTIC VIAL FOR BIOLOGICS & GENE/CELL THERAPY
PREFILLED SYRINGES
Hiroki Hasegawa
Mitsubishi Gas Chemical
NEW EXTRACTABLES DATA FOR OXYCAPT™ MULTILAYER PLASTIC VIAL FOR BIOLOGICS & GENE/CELL THERAPY
Hiroki Hasegawa and Tomohiro Suzuki review the properties of OXYCAPT™, Mitsubishi Gas Chemical’s multilayer material for primary biologic packaging, and share the data from the latest study on OXYCAPT’s extractables profile.
PRIMARY PACKAGING CONSIDERATIONS FOR SUPPORTING COMPLIANCE TO ANNEX 1 REVISION
PREFILLED SYRINGES
Edouard Pagnoud
Aptar Pharma
PRIMARY PACKAGING CONSIDERATIONS FOR SUPPORTING COMPLIANCE TO ANNEX 1 REVISION
Edouard Pagnoud, Estelle Verger and Benjamin Brocco look at the new requirements associated with EMA GMP Annex 1 revision regarding injectable primary packaging for ensuring sterility and safety, and consider how Aptar's PremiumFill® can reduce the risk of contamination and defects.
RISING TO THE REGULATORY EVIDENCE CHALLENGE FOR HIGH-QUALITY COMBINATION PRODUCTS
PREFILLED SYRINGES
Victoria Morgan
West Pharmaceutical Services
RISING TO THE REGULATORY EVIDENCE CHALLENGE FOR HIGH-QUALITY COMBINATION PRODUCTS
Victoria Morgan and Stacy Gates-Rector explore how West is supporting pharma companies with packaging challenges through the supply of high-quality prefillable syringe plungers and provision of a highly co-ordinated technical documentation package.
BIOLOGIC INTEGRITY: MEASURING AND MANAGING THE HIDDEN LEACHABLES RISK FROM PFS ADHESIVE
INDUSTRIALISATION
Enrico Barichello
Stevanato Group
BIOLOGIC INTEGRITY: MEASURING AND MANAGING THE HIDDEN LEACHABLES RISK FROM PFS ADHESIVE
Enrico Barichello considers the often-overlooked influence of adhesive in the assembly of prefilled syringes and how the hidden risks can be managed and overcome.
NEEDLESTICK INJURY RISKS: SAFEGUARDING HEALTHCARE WORKERS AND PATIENTS
INJECTION
Dr Fred Metzmann
Roncadelle
NEEDLESTICK INJURY RISKS: SAFEGUARDING HEALTHCARE WORKERS AND PATIENTS
Fred Metzmann discusses how using safety syringes can be a cost-effective measure to reduce the risk of injury to healthcare personnel and patients, and introduces the company’s devices designed for safer drug administration.
GAS-POWERED AUTOINJECTOR PLATFORM ENABLES BIOLOGICS DRUG DELIVERY
INJECTION
Matt McCawley
Altaviz
GAS-POWERED AUTOINJECTOR PLATFORM ENABLES BIOLOGICS DRUG DELIVERY
Matt McCawley and Albie Lavin discuss Altaviz's universal biologics autoinjector platform, highlighting how its gas-powered drive system, based on Pico-Cylinders, provides numerous benefits over legacy spring-powered autoinjectors.
PICCOJECT – USING HUMAN FACTORS TO FULFIL PATIENTS’ NEED FOR INJECTION CONFIDENCE
INJECTION
Thomas Thueer
Haselmeier
PICCOJECT – USING HUMAN FACTORS TO FULFIL PATIENTS’ NEED FOR INJECTION CONFIDENCE
Thomas Thueer, Chris Muenzer and Ines Schlenker discuss the development of the enhanced usability features of PiccoJect, Haselmeier's novel autoinjector.
DEVICE INTERCHANGEABILITY STUDY OF THREE-STEP AND TWO-STEP AUTOINJECTORS
INJECTION
Alex Fong
Owen Mumford
DEVICE INTERCHANGEABILITY STUDY OF THREE-STEP AND TWO-STEP AUTOINJECTORS
Alex Fong discusses the results of a study assessing patients’ ability to switch from a three-step autoinjector to a two-step device.
ACCELERATING ACCESS: THE FUTURE OF INJECTABLES IS PREFILLED AND PLASTIC – AN INTERVIEW WITH APIJECT’S BO KOWALCZYK & JON ELLENTHAL
INTERVIEW
Bo Kowalczyk
ApiJect
ACCELERATING ACCESS: THE FUTURE OF INJECTABLES IS PREFILLED AND PLASTIC – AN INTERVIEW WITH APIJECT’S BO KOWALCZYK & JON ELLENTHAL
Bo Kowalczyk and Jon Ellenthal discuss the need for greater fill-finish capacity in the pharmaceutical industry highlighted by the covid-19 pandemic, and how ApiJect’s Blow-Fill-Seal prefilled injector platform aims to meet this need.
IDENTIFYING AND OVERCOMING THE CHALLENGES OF INJECTABLE COMBINATION PRODUCT EVOLUTION
EXPERT VIEW
David DeSalvo
IDENTIFYING AND OVERCOMING THE CHALLENGES OF INJECTABLE COMBINATION PRODUCT EVOLUTION
David DeSalvo considers some potential challenges that the rapid evolution of autoinjectors (and combination product injectables in general) raises, along with how the industry can successfully address this cycle of reinvention.
SUCCESSFUL INDUSTRIALISATION REQUIRES SOLID FOUNDATIONS
INDUSTRIALISATION
Jennifer Riter
West Pharmaceutical Services
SUCCESSFUL INDUSTRIALISATION REQUIRES SOLID FOUNDATIONS
Jennifer Riter and Victoria Morgan discuss the importance of choosing the right containment system at the start for successful industrialisation of an injectable drug product.
DIGITAL TWIN IN THE PHARMACEUTICAL SUPPLY CHAIN
CONNECTIVITY
Ali Badiei
Gerresheimer
DIGITAL TWIN IN THE PHARMACEUTICAL SUPPLY CHAIN
Gerresheimer’s Ali Badiei explains the role of digital twin technology and its integration into the pharmaceutical supply chain, highlighting an innovative approach to ensuring drug identity and quality.
Interview with Arnaud Guillet & Fanny Sellier
INTERVIEW
Arnaud Guillet
Biocorp
Interview with Arnaud Guillet & Fanny Sellier
Arnaud Guillet and Fanny Sellier talk with Guy Furness about how Biocorp has become a key player in the field of connected drug delivery, discuss the current landscape for connectivity in drug delivery and update us on its two major parenteral products – Mallya and Injay – as well as looking forward to the launch of the company’s next generation of connected drug delivery solutions.
HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT
CONNECTIVITY
Finola Austin
Owen Mumford
HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT
Finola Austin looks at the role human factors testing plays in the development of connected drug delivery devices.
STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS
EXPERT VIEW
Deepu Asok
STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS
Deepu Asok discusses the importance of test method validation for drug-device combination product development and how a common mistake is to design the validation process for a specific device rather than to accommodate the potential variety of a device platform.
OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES
INJECTION
Tomohiro Suzuki
Mitsubishi Gas Chemical
OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES
Tomohiro Suzuki reviews the advantages that OXYCAPT™, Mitsubishi Gas Chemical's multilayer material for vials, offers to biologics and gene and cell therapies, and discusses the results of recent tests into low-temperature storage and dimethyl sulfoxide resistance.
OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION
OCULAR
Yuki Takeuchi
Terumo Medical Care Solutions
OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION
Yuki Takeuchi and Richard Whelton discuss the challenges of delivering intravitreal injections and how the combination of Terumo’s PLAJEX™ prefillable syringes with Congruence’s Microlitre Dosing Syringe system is able to address them.
INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE
OCULAR
Dr Andrea Allmendinger
ten23 health
INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE
Andrea Allmendinger and Hanns-Christian Mahler highlight the technical challenges of intravitreal administration and considerations from the ophthalmologist’s and patient’s perspectives.
PATIENT-CENTRIC DESIGN CAN BE A FASTER PATH TO MARKET
INJECTION
Dr Brent Buchine
Windgap Medical
PATIENT-CENTRIC DESIGN CAN BE A FASTER PATH TO MARKET
Brent Buchine considers a faster path to market for automated and easy-to-use reconstitution devices through simplification of the delivery systems.
OPPORTUNITIES FOR INNOVATION WITH BIOSIMILARS
PREFILLED SYRINGES
Dr Iain Simpson
Phillips-Medisize
OPPORTUNITIES FOR INNOVATION WITH BIOSIMILARS
Iain Simpson and George Spooner investigate the use of drug delivery systems that support self-administration of biologic drugs, and specifically biosimilars, for the treatment of chronic diseases. This article is based on research conducted by both authors as part of the MPhil in Therapeutic Sciences at the University of Cambridge (UK) and supported by Phillips-Medisize.
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