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INJECTION
DUAL CHAMBER
FORMULATION
PFS
WEARABLES
ALL INJECTION
OCULAR
ORAL
RESPIRATORY
PULMONARY
NASAL
ALL RESPIRATORY
SKIN
SUSTAINABILITY
MORE
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EARLY INSIGHTS
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INDUSTRIALISATION
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
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.
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.
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.
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.
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.
INDUSTRIALISATION
Mark Foster
Oliver Design
WHEN SECONDARY PACKAGING IS A PRIMARY CONCERN
Mark Foster discusses the challenges to optimising primary and secondary packaging for parenteral drug delivery devices, including higher level challenges from the patient perspective, as well as how these challenges present opportunities for device developers to stand out in the market.
WEARABLES
Heiko Haller
ZwickRoell
PRODUCT SHOWCASE: COMPLETE SYSTEM FOR STANDARD-COMPLIANT TESTING OF WEARABLE INJECTORS
Specifically tailored to on-body delivery systems (OBDSs) / wearable injectors, ZwickRoell showcases its customised, comprehensive solution for performing functional tests in accordance with the ISO 11608-6 standard.
INDUSTRIALISATION
Dr Ben Knappett
Particle Works
HIGH-THROUGHPUT SCREENING TO ACCELERATE NANOMEDICINE DISCOVERY
Ben Knappett discusses how the successful combination of microfluidics with automation can provide rapid and cost-effective high-throughput lipid nanoparticle technology formulation screening, and how this approach could play a significant role in advancing the development of new nanotherapies.
EXPERT VIEW
Phil Sampey
DFM & DFA: THE DIFFERENCES, BENEFITS AND HOW TO IMPLEMENT THEM
Phil Sampey discusses the principles associated with design-for-manufacture (DFM) and design-for-assembly (DFA) methodologies as applied to drug delivery device design, giving an overview of what each involves and key areas of focus to ensure that the full benefits of these approaches can be realised.
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.
INTERVIEW
Julien Martins
Paragon Medical
Interview with Julien Martins & David Philbrick
Julien Martins and David Philbrick talk exclusively with ONdrugDelivery's Guy Furness. They discuss a wide range of topics, including the services Paragon Medical provides the drug delivery industry, its wider business operations, the company’s expanded facilities in the US and Europe, and its new Advanced Surgical Innovation Center.
INDUSTRIALISATION
Hans Arts
IGS GeboJagema
STREAMLINING DRUG DELIVERY DEVICE DEVELOPMENT FOR INDUSTRIALISATION SUCCESS
Hans Arts, Jan-Willem Den Hollander and Ron Cisliek discuss the value of bringing an industrialisation partner on board early in product development and how working with a single manufacturing specialist can preserve insights and learnings throughout the product development lifecycle and deliver additional value and quality.
INDUSTRIALISATION
Mads Keinicke Hansen
Stevanato Group
HOW A FLEXIBLE APPROACH TO AUTOINJECTOR ASSEMBLY EQUIPMENT CAN DELIVER A COMPETITIVE ADVANTAGE
Mads Keinicke Hansen presents an overview of the company’s Standard Autoinjector Assembly Machine platform, providing an in-depth examination of its key features and advantages to illustrate how it is transforming autoinjector assembly processes in the pharmaceutical industry.
INDUSTRIALISATION
Yacine Haddadi
BD (Becton Dickinson & Company)
RFID-BASED UNIT-LEVEL TRACEABILITY: COULD IT BE THE KEY TO OPERATIONAL EXCELLENCE FOR FILL-FINISH LINES?
Yacine Haddadi and Herve Soukiassian look at how the company’s track & trace model can help manufacturers improve their fill-finish operations.
EXPERT VIEW
Matthew Burton
IMed Consultancy
ENTERING THE UK MARKET: A GUIDE FOR US MEDICAL DEVICES COMPANIES
Matthew Burton discusses the new EU Medical Device Registration and offers a guide for the UK Responsible Person within companies.
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.
INDUSTRIALISATION
Dr Andrea Allmendinger
ten23 health
INTEGRATED DRUG PRODUCT DEVELOPMENT AND MANUFACTURING
Andrea Allmendinger; Michael Adler and Hanns-Christian Mahler highlight the importance of integrated drug product development, considering aspects such as formulation, device, container closure system, manufacturing processes and usability, as well as considering the quality target product profile and clinical phase-appropriate technical development strategy.
PULMONARY
Dr Orest Lastow
Iconovo
NOVEL INDUSTRIAL-SCALE ELECTROSTATIC CHARGE ELIMINATION METHOD FOR INHALATION PRODUCTS
Orest Lastow describes a novel technique for removing the built-up charge from dry powder inhaler components, offering a potential solution to the issues caused by static charges in these devices, including decreased performance, altered powder properties and increased variability in delivered dose.
PULMONARY
Andy Cleall
3P Innovation
ARE YOU STRUGGLING TO PUT DIFFICULT POWDERS INTO CAPSULES?
Andy Cleall and Ben Smith discuss process optimisation and cutting-edge technology for powder filling, including how 3P’s R500 and R1000 robotic capsule fillers are pushing the boundaries of optimal filling and how its Fill2Weight technology enables increased filling accuracy and improved yields.
PULMONARY
Dr Rui Churro
Hovione
CAPSULE FILLING FOR DPIs – LINKING PROCESS SCALES THROUGH ADVANCED CHARACTERISATION AND QUALITY BY DESIGN
Rui Churro, Carolina Lopes and João Pires discuss the value of rheological characterisation of powders to expedite and de-risk the scale-up of DPI capsule-filling processes.
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.
INDUSTRIALISATION
Peter Schmidt
ZwickRoell
PRODUCT SHOWCASE: New Requirements for Injection Devices Make Advanced Testing Solutions Necessary
ZwickRoell showcases its advanced testing solutions for injection devices including pens, autoinjectors and on-body delivery systems.
INTERVIEW
Guy Furness
Kymanox
Interview: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen
Mathias Romacker, Fran DeGrazio and Paul Jansen sit down with Guy Furness, to discuss what it is that has driven Kymanox’s rapid rise in the drug delivery space and what makes the consulting company’s model so successful, as well as to share their expertise on a variety of topics in an illuminating discussion, including connectivity, how large and small drug developers engage with consultancies, 5 mL autoinjectors and the interface between drug primary packaging and delivery devices.
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