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COLD STORAGE AND CONTAINER CLOSURE INTEGRITY – DEMONSTRATED PERFORMANCE OF ETFE-COATED COMPONENTS

Aptar Pharma's Sebastien Cordier, Benjamin Brocco, Estelle Verger and Arnaud Clausse discuss the results of a series of tests to demonstrate that PremiumCoat^® can maintain closure integrity down to -80°C.

HOW PATIENT & TREATMENT FACTORS SHAPE SUBCUTANEOUS DOSING PREFERENCES

Andreas Schneider highlights the importance of understanding the drivers of dosing preferences when it comes to choosing the right injection device for patients. Specifically, the research summarised here studies whether and how patient characteristics and treatment attributes influence the decision to use prefilled handheld autoinjectors or large-volume wearable injectors.

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.

ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS

ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS

Timothy Bubb discusses the five steps to setting up an effective post-market surveillance process.

INTEGRATED DRUG PRODUCT DEVELOPMENT AND MANUFACTURING

INDUSTRIALISATION

Dr Andrea Allmendinger

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.

DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS

DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS

Thomas James highlights the importance of early user engagement, as well as continuous refinement of information and workflow design, for efficient development of drug-device combination products for emergency use.

TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS

TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS

John Burke considers the challenges that manufacturers need to overcome when designing emergency-use autoinjectors.

ADDRESSING PEPTIDE THERAPEUTICS WITH A VERSATILE PEN PLATFORM

ADDRESSING PEPTIDE THERAPEUTICS WITH A VERSATILE PEN PLATFORM

Cécile Gross and Mark Tunkel discuss the rising demand in peptide therapeutics and how Nemera’s PenVario pen injector platform, coupled with Nemera’s end-to-end service offering, has been designed to help pharma partners achieve success in this sector.

STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS

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

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.

MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES

MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES

Eugene Polini discusses the importance of container closure for the parenteral drug market, including some of the consequences of compromised container closure and what steps manufacturers can take to ensure that primary packaging systems remain sealed for a product’s entire shelf life.

DESIGNING SUSTAINABILITY INTO PHARMACEUTICAL DEVICES

DESIGNING SUSTAINABILITY INTO PHARMACEUTICAL DEVICES

Will Davies discusses in detail how to address the challenges of designing sustainability into pharmaceutical devices.

IMPROVING RECYCLABILITY IN DRUG DELIVERY

Julien Tremblin

IMPROVING RECYCLABILITY IN DRUG DELIVERY

Julien Tremblin looks at the recyclability challenges facing the drug delivery market and considers how companies can enhance the recyclability of their packaging and devices.

COMMITTED TO SUSTAINABILITY!

Sandrine Coutarel

COMMITTED TO SUSTAINABILITY!

Sandrine Coutarel looks at the company’s sustainability road map and the steps being taken to achieve its aims.

NAVIGATING pMDI REFORMULATION 2.0

NAVIGATING pMDI REFORMULATION 2.0

Chris Baron and William Ganley examine possible responses to the environmental impact of pressurised metered dose inhalers use and consider alternative inhaler types, with a focus on the strategies and support that can accelerate the development of the next generation of pMDIs.

NAVIGATING THE CHALLENGES OF BRINGING INTRANASAL DRUG FORMULATIONS & DEVICES TO PATIENTS

NAVIGATING THE CHALLENGES OF BRINGING INTRANASAL DRUG FORMULATIONS & DEVICES TO PATIENTS

Joe Neale and Ross Errington explore the obstacles and opportunities facing the intranasal drug delivery market and how manufacturers can overcome them by harnessing innovative platforms like Unidose^® Xtra.

CONNECT IN PHARMA REPORT: FUTURE TRENDS IN DRUG DELIVERY DEVICES

CONFERENCE SHOWCASE

CONNECT IN PHARMA REPORT: FUTURE TRENDS IN DRUG DELIVERY DEVICES

A new report from the organisers of Connect in Pharma, “The Future of Pharma Production, Manufacturing and Packaging Trend Report”, has highlighted a range of forces shaping the future of the pharmaceutical manufacturing and drug-delivery industry.

THE APPLICATION DIVERSITY OF METERED PUMP-BASED SOFT MIST DEVICES

Dr Marie-Christine Klein

THE APPLICATION DIVERSITY OF METERED PUMP-BASED SOFT MIST DEVICES

Marie-Christine Klein, Andreas Bilstein and Caroline Hoffmann discuss the underlying techniques involved in the use of metered pump-based soft mist devices and their application diversity.

NOVEL INDUSTRIAL-SCALE ELECTROSTATIC CHARGE ELIMINATION METHOD FOR INHALATION PRODUCTS

Dr Orest Lastow

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.

DEVELOPMENT APPROACH FOR A HIGH-PERFORMANCE CAPSULE-BASED DPI

Dr Mirjam Kobler

DEVELOPMENT APPROACH FOR A HIGH-PERFORMANCE CAPSULE-BASED DPI

Mirjam Kobler, Ameet Sule and Sunita Sule look at the factors affecting the performance of dry powder inhalers and discuss the company’s development of high-performance prototypes.

ARE YOU STRUGGLING TO PUT DIFFICULT POWDERS INTO CAPSULES?

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.

THE POTENTIAL AND THE CHALLENGES OF NASAL VACCINATION

THE POTENTIAL AND THE CHALLENGES OF NASAL VACCINATION

Julie Suman and Nektaria Karavas discuss the challenges and opportunities of intranasal vaccination – showcasing current understanding for both liquid and powder products. Experimental studies highlight critical issues, the performance of commercially available devices and developments in formulation practice.

CAPSULE FILLING FOR DPIs – LINKING PROCESS SCALES THROUGH ADVANCED CHARACTERISATION AND QUALITY BY DESIGN

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.

DUE DILIGENCE – THE KEY TO SUCCESS IN DRUG DELIVERY DEVICE SELECTION

DUE DILIGENCE – THE KEY TO SUCCESS IN DRUG DELIVERY DEVICE SELECTION

Matt Jones and Rob Veasey consider the process of matching the drug with the right delivery device and look at the importance of due diligence when “licensing in” technology.

CONSIDERATIONS WHEN SWITCHING FROM CURRENT pMDI PROPELLANTS TO NEW LOWER-GWP PROPELLANTS

CONSIDERATIONS WHEN SWITCHING FROM CURRENT pMDI PROPELLANTS TO NEW LOWER-GWP PROPELLANTS

Mark Parry discusses the considerations that need to be made when switching from current pressurised metered dose inhaler propellants to new alternatives with lower global warming potential, including formulation, regulatory and analytical standpoints.

UNLOCKING THE POTENTIAL OF MICRONEEDLE TECHNOLOGY

Bart van Oorschot

UNLOCKING THE POTENTIAL OF MICRONEEDLE TECHNOLOGY

Bart van Oorschot and Maarten Smit discuss the exciting potential of microneedle-based delivery systems to transform the drug delivery industry, the challenges faced by this technology and how the use of an applicator may be the way to overcome them.

SAY “NO MORE” TO NEEDLES: NEEDLE-FREE SELF-INJECTION TECHNOLOGY FOR PAINLESS, BETTER CARE

SAY “NO MORE” TO NEEDLES: NEEDLE-FREE SELF-INJECTION TECHNOLOGY FOR PAINLESS, BETTER CARE

Alina Su discusses the need for improved and optimised remote healthcare to meet current challenges in the industry, and introduces Telosis, the company’s patent-pending connected needle-free injection device that is poised to provide answers to these challenges.

THE NEXT GENERATION OF MICRONEEDLES: HARNESSING A BILLION YEARS OF EVOLUTION

Dr Gabriel Villar

THE NEXT GENERATION OF MICRONEEDLES: HARNESSING A BILLION YEARS OF EVOLUTION

Gabriel Villar and Ethan Miller consider examples of nature’s solutions to four challenges faced by microneedles for drug delivery. For each challenge, the authors explain how a natural organism has tackled it and what lessons may be directly applied to microneedle design.

Microneedle & Transdermal Drug Delivery Forum 2023

18th Sep 2023 - 19th Sep 2023

Philadelphia, PA, USA

Microneedle & Transdermal Drug Delivery Forum 2023

The drug delivery industry is on the threshold of bringing into commercial production a new generation of transformative skin-mediated delivery systems. That is why you cannot afford to miss Pharma Ed’s Microneedle & Transdermal Drug Delivery Forum. Leading researchers from industry and academia come together to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

OVERCOMING CHALLENGES WHEN DEVELOPING OLIGONUCLEOTIDES FOR OPHTHALMIC DRUGS

OVERCOMING CHALLENGES WHEN DEVELOPING OLIGONUCLEOTIDES FOR OPHTHALMIC DRUGS

Shiyan Chen and Binbin Tian discuss the use of oligonucleotides for ophthalmic applications, including their potential uses, advantages, challenges and difficulties when it comes to pharmacokinetic and drug metabolism studies.

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Dr Andrea Allmendinger

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.

DRUG DELIVERY PLATFORM DRIVES NEW OPPORTUNITIES FOR CONTINUOUS-DELIVERY GLAUCOMA TREATMENT

DRUG DELIVERY PLATFORM DRIVES NEW OPPORTUNITIES FOR CONTINUOUS-DELIVERY GLAUCOMA TREATMENT

Harsh Patel, Cyonna Holmes and Brian Wilson discuss how Celanese’s VitalDose^® EVA drug delivery platform can help reduce intraocular pressure by creating a desired therapeutic release profile.

NOVELIA<sup>®</sup>: A CLEAR VISION FOR EYE CARE FOR PATIENTS GLOBALLY

NOVELIA^®: A CLEAR VISION FOR EYE CARE FOR PATIENTS GLOBALLY

Zoë Davidson discusses the benefits of Novelia^®, Nemera’s alternative to sterile filters for multidose eye droppers for preservative-free formulations.

MISTGO<sup>®</sup> – A NEW MICRODOSING EYE MEDICATION DELIVERY SYSTEM

MISTGO^® – A NEW MICRODOSING EYE MEDICATION DELIVERY SYSTEM

Rie Saabye and Morten Jacobsen discuss the benefits of a new microdosing eye medication delivery system for chronic ophthalmic diseases, such as dry eye disease and glaucoma.

TOPICAL DRUG ADMINISTRATION FOR THE POSTERIOR SEGMENT

Dr David Bingaman

TOPICAL DRUG ADMINISTRATION FOR THE POSTERIOR SEGMENT

David Bingaman explores the potential benefits of topical administration for diseases affecting the posterior segment of the eye.

BEYOND THE EYEDROPPER BOTTLE – THREE WAYS TO IMPROVE ADHERENCE

Dr Nathan Wilkinson

BEYOND THE EYEDROPPER BOTTLE – THREE WAYS TO IMPROVE ADHERENCE

Nathan Wilkinson, Catherine Wyman and Matt Parker discuss the future outlook of ophthalmic drug delivery beyond the traditional eyedropper bottle, including new delivery technologies, sustained-release therapeutics and digital healthcare applications.

A SIGHT FOR SORE EYES: CHALLENGES & INNOVATIONS IN OPHTHALMIC DRUG DELIVERY

Dr Ethan Miller

A SIGHT FOR SORE EYES: CHALLENGES & INNOVATIONS IN OPHTHALMIC DRUG DELIVERY

Ethan Miller and Kristien De Clercq discuss recent advancements and current challenges in the field of ophthalmology, including the trend towards preservative-free multidose delivery systems, delivering smaller topical volumes with increased drug efficacy, slow-release injections for delivery to the posterior of the eye and the exciting field of gene therapy.

NEXT-GENERATION AUTOINJECTOR PLATFORM FOR HIGH-DOSE DRUGS

Richard Whelton

Congruence Medical Solutions

NEXT-GENERATION AUTOINJECTOR PLATFORM FOR HIGH-DOSE DRUGS

Richard Whelton introduces the new Congruence Autoinjector, a next-generation disposable autoinjector platform, which leverages a compressed-gas power source and has significant advantages over currently available legacy devices, including the ability to deliver higher viscosity and larger volume drugs, easier customisation and enhanced usability that addresses well-known user errors.

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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