ONdrugDelivery - ONdrugDelivery - drug delivery industry specialised b2b information

INDUSTRIALISATION

EXPANDING AUTOMATION CAPACITY FOR HIGH AND LOW VOLUMES

SHL's Gilbert Fluetsch and Lucy Chung look at how automation and assembly services can best evolve and adapt to industry standards and market demands, whilst delivering consistently at high quality and in a timely manner.

INDUSTRIALISATION OF INHALATION PRODUCTS: OVERCOMING HURDLES AT COMMERCIAL SCALE

Robin Heath discusses the typical challenges in scaling-up drug products from small-scale production to commercial manufacturing – and how these can be overcome.

INDUSTRIALISATION

AUTOMATING PREVIOUSLY IMPOSSIBLE MANUAL INSPECTIONS USING MACHINE LEARNING & CONCURRENT VALIDATION

Steve Wardell and Catherine Thacker explore how machine learning technology is enabling the automation of challenging, or previously impossible, manual inspections.

Sarah Trenfield

PERSONALISING DRUG PRODUCTS USING 3D PRINTING

Sarah Trenfield and Abdul Basit look at the potential applications of 3D-printing technology to create personalised drug therapies in fields such as multiple drug therapy and paediatric/geriatric care and introduce FabRx’s 3D-printing system, which can produce formulations to suit a variety of situations.

INDUSTRIALISATION

Berthold Schopferer

Z.BLIZZARD AUTOMATION SYSTEM – IT DOESN’T GET MORE TAILOR-MADE THAN THIS

Berthold Schopferer explains how the Zahoransky’s integrated syringe manufacturing and assembly equipment allows maximum customisation and full customer involvement.

3D PRINTING DRUGS: LEARNING FROM THE PIONEERS

Jamie Clayton reviews the potential of 3D printing as a pharmaceutical production method and looks at the associated implications for formulation development, focusing on powder-based printing. He examines what leading experts now understand about how to specify powder feeds for 3D printing.

Dr Aline Moulin

COMPACTION SIMULATION / INDUSTRIAL PRESS CORRELATION: TWO CASE STUDIES

Aline Moulin and Lucile Kowalski examine two case studies comparing compaction simulation with industrial compression.

BD (Becton Dickinson & Company)

Cecile Halte, BD

In this interview, Cécile Halté, Senior Program Manager, Acute Care Segment, for BD Medical – Pharmaceutical Systems. discusses validation studies of the BD Sterifill Advance™ plastic prefilled syringe, which is intended for use in the hospital setting by healthcare professionals either for manual bolus injections, or with infusion pumps.

Bob Tilling, Kallik

In this interview, Bob Tilling, Business Development Manager at Kallik, shares his insights on best practice for factory labelling.

INDUSTRIALISATION

Michael Wiglenda

Gerresheimer AG

A FIVE-STEP APPROACH TO INNOVATION IN DRUG DELIVERY SYSTEMS

Michael Wiglenda explains Gerresheimer’s industrialisation offering and the five-step Gate-Model that guides its innovation process.

INDUSTRIALISATION

Jose Luis Encinas

QUALI-V EXTRA DRY: A NOVEL CAPSULE FOR DELIVERING HYGROSCOPIC FORMULATIONS

Jose Luis Encinas and Susana Ecenarro explore how the use of Quali-V^® Extra Dry capsules can help improve product stability and, crucially, lead to efficiencies and savings in drug product manufacture.

CUSTOMISED INFUSION PUMPS: THE FUTURE OF SELF-ADMINISTRATION?

Shaul Eitan explores the challenges of home infusion and examines how customisation and connectivity could help provide a solution.

Dr Ramin Rafiei

MACRO TRENDS ACCELERATING THE ADOPTION OF CONNECTIVITY IN DRUG DELIVERY

Ramin Rafiei argues that connected therapeutics – the augmentation of drugs through sensors and connectivity – are now a clinical source for real-world data and provide an opportunity to bridge the efficacy-to-effectiveness gap. This next frontier in drug delivery, powered by connected therapeutics, will be data-driven, personalised, outcomes-based and accessible.

Eric Dessertenne

COMPLETING ITS TRANSITION FROM GENESIS TO MATURITY, BIOCORP OPENS NEW HORIZONS

As Biocorp prepares for the market launch of its connected injector pen add-on, Mallya, Eric Dessertenne and Arnaud Guillet share insights about key steps in the company’s development. The article discusses the many partnership Biocorp has entered in to, and includes a mini-interview with Sergio Monti, Plant Manager for one such partner, V.A.R.I.

CONNECTED DEVICES – MEDICATION DELIVERY JUST GOT PERSONAL

Thierry Decock and Hadrien Gremillet explore how the obstacles to the adoption of connectivity can be overcome and how connected devices can deliver truly patient-centric care that will clearly improve adherence rates, whilst demonstrating a clear cost benefit to the pharmaceutical partner.

Dr Mircea Despa

BD (Becton Dickinson & Company)

MIRCEA DESPA & DOUG McCLURE, BD

In this interview, Dr Despa and Mr McClure discuss BD’s approach to connecting devices in its portfolio to meet patient, pharma and other stakeholder requirements. Their discussion focuses in particular on safety and security, highlighting the connected wearable injector, BD Libertas™ with Smart Option, as an example.

Napoleon Monroe

CONNECTIVITY RESTORING TRUST IN PHARMA COMMUNICATIONS

Napoleon Monroe analyses connectivity coverage at recent drug delivery conferences and, more broadly, in various publications, to evaluate the current direction, and explore the scope for connectivity to effect changes benefiting multiple stakeholders across a range of treatment categories.

DON’T DEVELOP A CONNECTED DRUG DELIVERY DEVICE WITHOUT READING THIS

Matt Jones summarises some of the key challenges and opportunities in the development of connected drug delivery devices, focusing in detail on deciding what a connected drug delivery device should do, designing for a coin cell, direct cellular connection and antenna design.

USER-CENTERED DEVICE CONNECTIVITY

Mark Tunkel and Carolyn Rose discuss the benefits of taking a user-needs approach, and mapping the patient journey, in a connectivity strategy.

PUSHING THE BOUNDARIES OF INFUSION PUMP INTEROPERABILITY

Interoperability is not a new concept for infusion pumps. But in many cases hospitals have been slow to embrace the full potential of connectivity. When is this likely to change? What will hospitals need when it does? And where should infusion pump manufacturers focus innovation efforts in the meantime? Tim Frearson considers the options.

Phillips-Medisize

LOW-COST CONNECTIVITY MEETS PATIENT & PHARMA MEDICATION MANAGEMENT NEEDS

Neil Williams describes the potential connected drug delivery systems hold to address serious challenges in healthcare, including poor adherence, and also deliver substantial value, and outlines the company’s highly scalable enterprise platform, the Connected Health Platform.

ADHERENCE TO SELF-INJECTION REGIMENS CAN BE ENHANCED BY CONNECTED DEVICES

Craig Baker looks at the factors contributing to non-adherence and explores how connected devices can help patients follow their self-injection regimens.

E3D – Elcam Drug Delivery Devices

ADDING CONNECTIVITY TO DRUG DELIVERY DEVICES

Tsachi Shaked explores how – as the trend towards moving healthcare from the hospital to the home continues – connectivity in drug delivery devices may be changing from being the exception to the rule.

#97 May 2019 - UL by Emergo_Featured

Allison Strochlic

SIMULATING STRESSFUL, EMERGENCY-USE SCENARIOS DURING USABILITY TESTS OF INJECTION DEVICES

Allison Strochlic highlights the importance of simulating environments that are as realistic as possible when conducting usability tests of emergency-use injection devices, and provides case studies with examples of how to create more realistic tests.

Subcujet_feature1

A PATIENT CENTRIC AND PHARMA COMPANY CENTRIC PREFILLED WEARABLE BOLUS INJECTOR

Jesper Roested explains why the pharma/biotech drug development process often means device selection occurs after Phase II despite the advantages of earlier selection being well understood, and how this then precludes the selection of novel primary packaging and delivery systems.

#97_2019_Cristal_featured

Dr Cristianne Rijcken

Cristal Therapeutics

COMPANY SHOWCASE: Cristal Therapeutics

Over the past year, Cristal Therapeutics has transitioned from a research-stage start-up to a fully fledged, clinical-stage business with a promising pipeline of proprietary drug candidates. This diverse pipeline together with the proprietary nanoparticle platform, CriPec^®, presents a broad range of promising late- and early-stage partnering opportunities for companies active in the oncology space.

#97 May 2019 DDF Berlin featured

CONFERENCE REVIEW

10TH GLOBAL DRUG DELIVERY & FORMULATION (DDF) SUMMIT, Berlin, Germany, March 11–13, 2019

The second week of March is a key date in the delivery and formulation event calendar. This is when the good and the great of Europe’s pharmaceutical development community gather in Berlin, Germany, for the DDF Summit – a high-level scientific event for industry and academia.

#97_May_2019_Roquette_featured

Dr Elham Blouet

A NEW MULTI-COMPENDIA MODIFIED BETA-CYCLODEXTRIN, KLEPTOSE^® HPB-LB PARENTERAL GRADE

Elham Blouet introduces the latest addition to the company’s range of beta-cyclodextrins, and outlines the benefits it brings.

#97_May_2019_Credence_featured

Credence MedSystems

TECHNOLOGY SHOWCASE: Credence MedSystems Multi-Site™ Injection System

Credence MedSystems introduces the Multi-Site™ Injection System – a product that addresses specific needs in the high-growth dermal filler market.

Feature image

BD (Becton Dickinson & Company)

SELECTING THE RIGHT PRIMARY CONTAINER FOR INJECTABLES IN ACUTE CARE

Alfred Harvey explains why it’s important to select the right primary container presentation – and what can happen if you get it wrong.

Figure 3: West’s on-body injector platform, SmartDose®.

Victoria Morgan

West Pharmaceutical Services

ALTERING PATIENT TREATMENT: HOW SC DELIVERY CAN HELP PATIENTS MANAGE CHRONIC CONDITIONS

Victoria Morgan looks at the benefits of combining an active pharmaceutical product with a novel subcutaneous delivery device, and highlights some of the partnerships West has with biopharmaceutical and other companies, which have led to market launches of products incorporating its on-body delivery system.

Dr Gautam N Shetty

MICROLITRE DOSING WITH PREFILLABLE SYRINGES – WHEN DOES A DEVICE MAKE SENSE?

Gautam Shetty and Bernd Zeiss outline factors that need to be weighed when considering a device-based approach to microlitre injections.

Figure 1: OXYCAPT™ Vials and Syringes.

Takuya Minezaki

Mitsubishi Gas Chemical

MULTILAYER PLASTIC VIALS & SYRINGES FOR BIOLOGICS

Dr Takuya Minezaki and Tomohiro Suzuki, provide an overview of the company’s OXYCAPT™ Vials and Syringes, explaining how their multi-layered polymer material delivers the advantages of both COP and glass, and is especially suitable for biotherapeutics.

Wolfgang Moersch

PRODUCT SHOWCASE: Zwickroell Autoinjector Testing Platform

ZwickRoell introduces RoboTest, its automated autoinjector testing platform, which works together with the AutoEdition 3 automation software ad testXpert III testing software.

#97 May 2019 - enable_featured

PATIENT TOLERABILITY WITH HIGH-VISCOSITY, LARGE-VOLUME SUBCUTANEOUS INFUSIONS

Jennifer King and Matthew J Huddleston discuss the advantages of subcutaneous drug delivery and how these have yet to be fully harnessed in currently marketed therapeutics.

#97_May_2019_Weldon_Purdue_featured

Dr Chi Hwan Lee

Weldon School of Biomedical Engineering

SKIN-MOUNTABLE FLEXIBLE NEEDLE PATCH FOR MINIMALLY INVASIVE CONTROLLED DRUG DELIVERY

Chi Hwan Lee and Eun Kwang Lee introduce a skin-mountable flexible needle patch and discuss its applications in non-invasive drug delivery applications.

Zahoransky_featured

Berthold Schopferer

NEXT-LEVEL FUTURE MANUFACTURING FOR MEDICAL TECHNOLOGY

Berthold Schopferer explains the lengths the production equipment company goes to in its efforts to ensure the customer is always king.

ENABLING SUBCUTANEOUS DELIVERY OF BIOLOGICS

Elektrofi introduces Elektroject™, a gentle process for the production of ultra-high concentration protein formulations, that maintains a syringeable format and excellent protein stability, making the switch from intravenous to subcutaneous delivery viable for numerous biotherapeutics, including monoclonal antibodies.

#96_2019_Noble_featured

BEST PRACTICES FOR DEVELOPING EFFECTIVE TRAINING DEVICES FOR PULMONARY HEALTHCARE

Joe Reynolds discusses the current state of pulmonary drug delivery device trainers, including their value to patients, the complexities of modern design and the stringent quality requirements.

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