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.