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INDUSTRIALISATION
INDUSTRIALISATION
MANUFACTURING DPIS: CASE STUDY OF IMA ADAPTA
®
WITH BOEHRINGER INGELHEIM SPIRIVA
®
Pietro Piera and Rainer Bauer investigate the optimal process parameters for low-dose dry powder inhalers achieved by dosator technology, presenting a case study in which IMA’s capsule filler, Adapta
®
, is used to fill Boehringer Ingelheim’s Spiriva
®
(tiotropium) dry powder inhaler.
RESPIRATORY
HOW TO GAIN A FULL UNDERSTANDING OF POWDER FLOW PROPERTIES, AND THE BENEFITS OF DOING SO
Geoffroy Lumay, Naveen Mani Tripathi and Filip Francqui show how the association of three recently developed flow measurement techniques can be used to gain valuable insights into powder properties and characteristics.
PREFILLED SYRINGES
Shota Arakawa
Mitsubishi Gas Chemical
OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE
Shota Arakawa and Tomohiro Suzuki, discuss the benefits of the OXYCAPT™ multilayer plastic vial and syringe for the rapidly growing field of biologics and regenerative medicines.
EXPERT VIEW
Jos van Noort
CHOOSING THE RIGHT LABEL MATERIAL FOR PREFILLED SYRINGES
Jos van Noort outlines some of the key factors that must be taken into consideration when selecting a label for prefillable syringes.
PREFILLED SYRINGES
Wolfgang Moersch
ZwickRoell
PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform
ZwickRoell offers a wide variety of standardised test fixtures for parenteral devices including, described here: testing prefilled syringes to ISO 11040-4, -6 & -8; testing of Luer/Luer lock connections; serial, parallel and fully automatic syringe testing; and traceable, tamper-proof test results.
PREFILLED SYRINGES
Christian Helbig
SCHOTT
FINDING THE RIGHT PACKAGING FOR BIOLOGIC DRUGS
Christian Helbig introduces a new 2.25 mL version of SCHOTT’s syriQ BioPure® prefillable syringes designed specifically for the biologics market and, developed in partnership with WL Gore, the world’s first silicone-free glass syringe system.
CONNECTIVITY
Kelly Boyer
Colorcon
THE TRUSTED TABLET: A NEW LEVEL OF SUPPLY CHAIN SECURITY FROM MASS DIGITALISATION OF MEDICINES
Kelly Boyer, Trent Lund and Barry McDough describe a means of mass digitalising medicines to address the problem of illegal and unauthorised production of pharmaceutical products in a meaningful way.
EARLY INSIGHT
Nick Rollings
BiologIC Technologies
A FLEXIBLE, MODULAR PLATFORM TO DISRUPT THE BLOCKBUSTER MANUFACTURING MODEL
Nick Rollings, Colin Barker and Richard Vellacott discuss the drug delivery scenario in the advanced therapy (AT) era, examining how the current slow-moving blockbuster treatment model is making way for a fast-moving, patient-focused era of personalised medicine
PREFILLED SYRINGES
Roland Lindner
sortimat
LED-GENERATED UV FOR ADHESIVE CURING IN MEDICAL DEVICES
Roland Lindner, Matthias Schulze and Bill Jaworski discuss how the needs around adhesive use in the manufacture of medical devices such as glass syringes have evolved and how ATS sortimat has developed a new process to meet industry demands.
INDUSTRIALISATION
Simon Strothers
3P Innovation
F2V: A STERILE, CUSTOMISABLE LIQUID FILL-FINISH PLATFORM FOR THE TOTAL LIFECYCLE
Simon Strothers presents an integrated fill-finish platform, F2V, designed to represent a commercial filling system as a bench-top solution. The article also includes a recent case study where the F2V was used by Consort Medical to help develop and industrialise a flagship delivery device.
INDUSTRIALISATION
Berthold Schopferer
Zahoransky
Z.BLIZZARD AUTOMATION SYSTEM FOR PFS: IMPROVING THE LIVES OF PATIENTS
With the ultimate objective of improving patients’ lives, Berthold Schopferer provides an overview of the company’s customer-specific automated manufacturing and assembly equipment offering for prefillable polymer syringes.
INDUSTRIALISATION
Wolfgang Moersch
ZwickRoell
PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform
ZwickRoell provides an overview of its parenteral device testing platform including roboTest, and associated software testXpert III and autoEdition3.
EXPERT VIEW
Manuel Scherer
SHARING IS CARING: POLYMER SUPPLIERS AS MEDICAL DEVICE DEVELOPMENT PARTNERS
Manuel Scherer looks at whether the advent of wearable injectors calls for a more collaborative approach between polymer suppliers and medical device developers.
EXPERT VIEW
Dominique Bauert
PRIMARY PACKAGING FOR WEARABLE INJECTION DEVICES
Dominique Bauert and Anil Kumar Busimi provide an overview of existing wearable injector solutions and new requirements, with a focus on the role of the primary packaging inside the devices.
WEARABLES
Rolf Rihs
Mikron Automation
SCALABLE ASSEMBLY SOLUTIONS – FULLY INTEGRATED, TRULY GLOBAL
Rolf Rihs and Jean-François Bauer look at how Mikron has specialised in flexible, modular assembly solutions that are easy to evolve during the different stages of a product lifecycle: from development through to fully automated, maximum-performance production.
WEARABLES
Catherine Thacker
ATS Automation
MITIGATING RISK TO DELIVER SUCCESS IN HIGH-VOLUME WEARABLE DEVICES
Catherine Thacker and Bill Jaworski discuss risk reduction solutions in the manufacturing architecture for wearable injectors, including an example where autonomous intelligent vehicles and ATS‘s real-time industrial IoT manufacturing intelligence system, Illuminate®, were employed.
EARLY INSIGHT
Sarah Trenfield
FabRx
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
Gilbert Fluetsch
SHL Group
EXPANDING AUTOMATION CAPACITY FOR HIGH AND LOW VOLUMES
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
Berthold Schopferer
Zahoransky
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.
EXPERT VIEW
Jamie Clayton
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.
EXPERT VIEW
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.
EXPERT VIEW
Robin Heath
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.
INTERVIEW
Bob Tilling
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
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
Qualicaps
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.
INDUSTRIALISATION
Steve Wardell
ATS Automation
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.
INJECTION
Wolfgang Moersch
ZwickRoell
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.
INJECTION
Berthold Schopferer
Zahoransky
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.
EXPERT VIEW
Simon Drexler
AUTOMATING UNDER UNCERTAINTY – GOOD PRACTICES
Simon Drexler discusses lessons learned and good practices when dealing with uncertainty at the various stages of automation development for drug delivery device manufacturing.
INTERVIEW
Guillaume Brouet
Aptar Pharma
GUILLAUME BROUET, APTAR PHARMA
Guillaume Brouet talks with ONdrugDelivery Magazine about how Aptar Pharma uses its device development expertise and infrastructure to provide its pharmaceutical company customers a comprehensive services offering around device development, global regulatory approval and commercialisation.
INTERVIEW
Paul Allsop
Consort Medical
PAUL ALLSOP, MILES KOTTMAN, HANNAH PRIESTLY & JON REED, CONSORT GROUP
Consort Medical's Paul Allsop, Miles Kottman, Hannah Priestly and Jon Reed talk with ONdrugDelivery Magazine about the company’s integrated formulation and device offering, and focus on its simple, low-cost, single unit-dose, spring powered nasal device, Unidose Xtra.
SKIN
Cécile Morin
Gattefossé
SYNERGISING EXCIPIENTS TO BOOST SKIN DELIVERY
Cécile Morin and Delphine Marchaud discuss combining polar and apolar excipients in topical formulations in order produce synergies that maximise the performance of the drug.
EXPERT VIEW
Dr Nidhi Prakash Sapkal
ORAL THIN FILMS: NOVEL TECHNOLOGY & ITS CHALLENGES
Presented from both the technology and formulation perspectives, Nidhi Prakash Sapkal and Anwar Siraj Daud discuss the challenges of industrialising oral thin films, a promising but difficult dosage form.
EXPERT VIEW
Napoleon Monroe
BEYOND MANUFACTURING: INDUSTRIALISATION OF DRUG DELIVERY IN THE REAL WORLD
When discussing the industrialisation of drug delivery, it is natural to focus on the processes and management of manufacture. Napoleon Monroe provides a different perspective on the idea of drug delivery’s “Industrialisation” and what that might mean in the modern world of service industry.
INDUSTRIALISATION
Catherine Thacker
ATS Automation
INDUSTRIALISING DRUG DELIVERY SYSTEMS – A RISK-BASED APPROACH
Catherine Thacker and Tom Hayes discuss ATS Automation’s methodology for developing a manufacturing strategy for a drug delivery device, from fresh design to mass-produced product.
INDUSTRIALISATION
Dr Quentin Ribeyre
Granutools
MEASURING THE INFLUENCE OF TALC ON THE PROPERTIES OF LACTOSE POWDERS
Quentin Ribeyre
et al
describe how three of the company’s instruments can be used to characterise powder properties and behaviour, exemplified by experiments investigating the effects of adding talc to different lactose grades.
EXPERT VIEW
Beth Blackburn
THE BIGGEST MISTAKES COMPANIES MAKE COMMERCIALISING DRUG DELIVERY – AND WHAT TO DO ABOUT THEM
It is difficult to successfully scale-up a product to industrial production and launch, but it is much harder if design fundamentals are not adhered to. Beth Blackburn details the need for setting down requirements early in device development in order to avoid inadvertently undermining a product’s successful commercialisation.
INDUSTRIALISATION
Michael Wiglenda
Gerresheimer
A COMPREHENSIVE APPROACH TO PHARMA INDUSTRIALISATION PARTNERING
As a company offering contract services at every stage of drug delivery system development, Gerresheimer has a wealth of expertise and history in industrial-scale production. Michael Wiglenda explains Gerresheimer’s industrialisation offering in detail.
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