INDUSTRIALISATION

INDUSTRIALISATION

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

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.

PRODUCT SHOWCASE: COMPLETE SYSTEM FOR STANDARD-COMPLIANT TESTING OF WEARABLE INJECTORS

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.

WHEN SECONDARY PACKAGING IS A PRIMARY CONCERN

INDUSTRIALISATION

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.

HIGH-THROUGHPUT SCREENING TO ACCELERATE NANOMEDICINE DISCOVERY

INDUSTRIALISATION

Dr Ben Knappett

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.

DFM & DFA: THE DIFFERENCES, BENEFITS AND HOW TO IMPLEMENT THEM

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.

SUCCESSFUL INDUSTRIALISATION REQUIRES SOLID FOUNDATIONS

INDUSTRIALISATION

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 with Julien Martins & David Philbrick

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.

RFID-BASED UNIT-LEVEL TRACEABILITY: COULD IT BE THE KEY TO OPERATIONAL EXCELLENCE FOR FILL-FINISH LINES?

INDUSTRIALISATION

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.

ENTERING THE UK MARKET: A GUIDE FOR US MEDICAL DEVICES COMPANIES

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.

DIGITAL TWIN IN THE PHARMACEUTICAL SUPPLY CHAIN

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.

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.

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.

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.

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.

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.

PRODUCT SHOWCASE: New Requirements for Injection Devices Make Advanced Testing Solutions Necessary

INDUSTRIALISATION

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: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen

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.

Interview: Gabriel Zenker, Aptar Pharma

Interview: Gabriel Zenker, Aptar Pharma

Gabriel Zenker talks with ONdrugDelivery about Aptar Pharma’s ambitions for the parenterals sector. Mr Zenker explains how Aptar, already a major player in the pulmonary, nasal, ophthalmic and dermal markets, is undertaking a major expansion of its facilities, boosting the company’s capacity, capabilities and technologies, to provide its extensive service and product offering to the exciting injectables space.

THE OPERATIONS PERSPECTIVE: BEST PRACTICES FROM 70 YEARS IN INJECTION DEVICE MANUFACTURING

THE OPERATIONS PERSPECTIVE: BEST PRACTICES FROM 70 YEARS IN INJECTION DEVICE MANUFACTURING

John Swift looks at how the company has evolved over 70 years, introduces its latest disposable autoinjector, Aidaptus, and considers how it plans to actively reduce risk in its supply chain.

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

PREFILLED SYRINGES

Dr Andrea Allmendinger

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

Andrea Allmendinger and Hanns-Christian Mahler both at ten23 health, provide an insight into the challenges of integrated development of drug product and device design and fill-finish manufacturing operations.

GETTING A GRIP ON FRICTION – A CRUCIAL CONSIDERATION FOR INHALER DESIGN

GETTING A GRIP ON FRICTION – A CRUCIAL CONSIDERATION FOR INHALER DESIGN

Bryan Deacon discusses the importance of considering friction when developing a new inhaler design, providing an overview of some of the basic considerations friction raises, as well as highlighting how optimising friction early with the aid of a materials expert can reduce risk, lower cost and lead to a better product overall.

ENGINEERING EXPERTISE: DESIGN FOR EXCELLENCE

INDUSTRIALISATION

Drew Jelgerhuis

Scherdel Medtec North America

ENGINEERING EXPERTISE: DESIGN FOR EXCELLENCE

Drew Jelgerhuis looks at how a design-for-excellence (DFX) systematic approach can help manufacturers achieve their objectives.

HIGH-PRECISION INJECTION MOULDS FOR INHALERS: CHALLENGES AND SOLUTIONS

INDUSTRIALISATION

HIGH-PRECISION INJECTION MOULDS FOR INHALERS: CHALLENGES AND SOLUTIONS

Rob Doorakkers and Erwin van Huijksloot discuss the challenges and solutions of engineering and manufacturing high-precision injection moulds for inhalers.

SUSTAINABLE DESIGN & MANUFACTURE IN MEDICAL DEVICES: WHERE TO START

SUSTAINABLE DESIGN & MANUFACTURE IN MEDICAL DEVICES: WHERE TO START

Cormac O’Prey discusses the challenges and advantages of implementing circular economy principles in the medical device sector, with a particular consideration of the difficulty of making remanufacturing work for high-volume, low-value devices.

THE ENVIRONMENTAL IMPACT OF GLOBAL SUPPLY CHAIN LOGISTICS & SUPPLIER SELECTION

Alastair Willoughby

THE ENVIRONMENTAL IMPACT OF GLOBAL SUPPLY CHAIN LOGISTICS & SUPPLIER SELECTION

Alastair Willoughby looks at the factors affecting sustainability when considering global supply chain logistics and supplier selection.

SUSTAINABLE DESIGN FOR MEDICAL DEVICES

Stefano Vicenzetto

SUSTAINABLE DESIGN FOR MEDICAL DEVICES

How do you meet environmental and sustainability objectives when designing medical devices? And what design considerations enable the technical cycles, known as the 4R loops of circular economy: reuse, repair, remanufacture and recycle? Stefano Vicenzetto explores the Flex approach to design for environment for medical devices.

INDUSTRIALISATION OF CUSTOMISABLE PRODUCT PLATFORMS IN LIFE SCIENCES

INDUSTRIALISATION

Umit Ismail Tsavous

INDUSTRIALISATION OF CUSTOMISABLE PRODUCT PLATFORMS IN LIFE SCIENCES

Umit Ismail Tsavous, Carsten Köhler and Tom Nägele discuss customisation of product platforms in the life sciences field.

DEVELOPING, MANUFACTURING AND DELIVERING A FILL-FINISH PILOT LINE FOR TUB-BASED PREFILLED SYRINGES

INDUSTRIALISATION

DEVELOPING, MANUFACTURING AND DELIVERING A FILL-FINISH PILOT LINE FOR TUB-BASED PREFILLED SYRINGES

Jake Canner discusses the latest project arising out of 3P innovation’s partnership with Cambridge Pharma and its sister company Oval Medical Technologies – including the challenges involved and how they were overcome.

ISO 11608: WHAT THE NEW STANDARD MEANS FOR NIS MANUFACTURERS

Cambridge Design Partnership

ISO 11608: WHAT THE NEW STANDARD MEANS FOR NIS MANUFACTURERS

Steve Augustyn looks at ISO 11608 and what it means for needle-based injection device manufacturers.

REALISING REDUCTIONS IN DEAD VOLUMES WITHIN PREFILLED SYRINGES: A MANUFACTURER’S PERSPECTIVE

PREFILLED SYRINGES

Enrico Barichello

Stevanato Group

REALISING REDUCTIONS IN DEAD VOLUMES WITHIN PREFILLED SYRINGES: A MANUFACTURER’S PERSPECTIVE

Enrico Barichello considers the benefits of prefilled syringes, including cost and waste reduction, and looks at the impact and challenges of dead volume within the syringe.

DEVELOPING AN ON-BODY PLATFORM FOR EFFECTIVE POST-OPERATIVE PAIN MANAGEMENT

Stevanato Group

DEVELOPING AN ON-BODY PLATFORM FOR EFFECTIVE POST-OPERATIVE PAIN MANAGEMENT

Paolo Golfetto and Sheldon Moberg discuss a collaboration between Stevanato Group and Bexson Biomedical that meets an urgent unmet patient need.

MIKRON AUTOMATION: A LEADER IN THE COMPLEX ASSEMBLY OF ON-BODY INJECTORS

Jean-François Bauer

Mikron Automation

MIKRON AUTOMATION: A LEADER IN THE COMPLEX ASSEMBLY OF ON-BODY INJECTORS

Mikron Automation sets out its expertise in the assembly of on-body injectors, a field requiring exception precision and innovative approaches, as well as discussing how Mikron works with its partners from the very earliest stages of device development to help ensure projects are completed efficiently and successfully.

IMPROVE YOUR BIOPHARMACEUTICAL WORKFLOW: 6 BENEFITS OF SINGLE-USE SYSTEM TECHNOLOGIES

IMPROVE YOUR BIOPHARMACEUTICAL WORKFLOW: 6 BENEFITS OF SINGLE-USE SYSTEM TECHNOLOGIES

Sara Dorman discusses the benefits of single-use systems, including how they help accelerate a drug product’s journey to market securely and more sustainably.

FROM SIMULATION TO SPRING SATISFACTION

INDUSTRIALISATION

Drew Jelgerhuis

Scherdel Medtec North America

FROM SIMULATION TO SPRING SATISFACTION

Drew Jelgerhuis discusses the power of simulation to enhance a drug delivery device design project, including faster development times and reduced costs.

INDUSTRIALISATION OF PHARMACEUTICAL AND MEDICAL DEVICES IN THE SCIENTIFIC MOULDING APPROACH

INDUSTRIALISATION

INDUSTRIALISATION OF PHARMACEUTICAL AND MEDICAL DEVICES IN THE SCIENTIFIC MOULDING APPROACH

Thomas Rudolph, Markus Reil, Stefan Schumann and Tobias Weigert discuss Gerresheimer’s strategy for managing potential risks across the entire product lifecycle.

INDUSTRIALISATION AND SCALE-UP OF DRUG DELIVERY DEVICES

INDUSTRIALISATION

Dr Barry McDermott

West Pharmaceutical Services

INDUSTRIALISATION AND SCALE-UP OF DRUG DELIVERY DEVICES

Barry McDermott and Shari Krusniak look at the manufacturing processes involved in bringing a new drug delivery system and formulation to market.

EMBRACING OPPORTUNITIES PRESENTED BY DIGITALISATION: USING DATA TO DRIVE PERFORMANCE

INDUSTRIALISATION

Otto Abildgaard

Stevanato Group

EMBRACING OPPORTUNITIES PRESENTED BY DIGITALISATION: USING DATA TO DRIVE PERFORMANCE

Otto Abildgaard and Sebastian Berninger-Lund review the four-stage process Stevanato has developed to bring improvements in time to market through optimised manufacturing.

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