ONdrugDelivery | Global Drug Delivery Industry Information & Intelligence

INDUSTRIALISATION

INNOVATION AND AUTOMATION REUNITED – ENABLING SCALABLE FINAL ASSEMBLY FOR CARTRIDGE-BASED AUTOINJECTORS

Using SHL Medical‘s Reunite™ dual-chamber autoinjector and SHL Advantec‘s AOU™ assembly machine platform as a case study, Christy Chen and Alberto Flores explore the critical synergy between flexible automation architecture and expert final assembly services.

MICRONISATION SUCCESS STARTS WITH SOLID-STATE UNDERSTANDING

Dr Derek Beauchamp and John Kusnierz explain how solid-state characterisation underpins the behaviour of a drug substance under processing conditions, and consider the importance of micronisation in improving bioavailability and drug product performance.

FROM SMALL TO LARGE MOLECULES: ADVANCING PRECISION PUMP TECHNOLOGY FOR BIOLOGIC DRUG DELIVERY

Dr Ines Rüstenberg, Roger Müller and Dr Yannick Schmid, discuss solutions for large-molecule drug delivery, highlighting the applicability of two infusors, Gx InPuls and Gx InPuls Flex, which employ micropump technology to overcome challenges with large-molecule delivery.

INJECTION-MOULDED PROTOTYPES FROM 3D-PRINTED TOOLING: ACCELERATING DRUG DELIVERY DEVICE DEVELOPMENT

INDUSTRIALISATION

INJECTION-MOULDED PROTOTYPES FROM 3D-PRINTED TOOLING: ACCELERATING DRUG DELIVERY DEVICE DEVELOPMENT

David Valencia and Martí Giralt discuss the value that 3D-printed tooling can bring to prototyping injection-moulded components for drug delivery devices, enabling rapid turnaround and iteration of designs while remaining functionally representative of the final commercial parts.

LYOPHILISATION VIALS: QUICK AND EFFECTIVE SOLUTIONS TO REDUCE FOGGING

INDUSTRIALISATION

Diane McCormick

NIPRO PharmaPackaging

LYOPHILISATION VIALS: QUICK AND EFFECTIVE SOLUTIONS TO REDUCE FOGGING

Diane McCormick and Clément Condouret discuss lyophilisation fogging, explaining its negative downstream effects and presenting NIPRO’s thermal treatment, VIALEX™, to minimise this issue.

PHARMASHELL – AN ALD NANOCOATING TECHNOLOGY FOR ONCE-MONTHLY INJECTABLES

Dr Anders Johansson

PHARMASHELL – AN ALD NANOCOATING TECHNOLOGY FOR ONCE-MONTHLY INJECTABLES

Dr Anders Johansson, Dr Polla Rouf and Dr Oliver Hedge introduce Nanexa’s PharmaShell® technology and discuss how, in combination with nanotechnology, it can achieve previously unattainable dosing intervals with standard formulations.

DESIGNING FOR SCALE: RELIABLE MANUFACTURING OF PEN INJECTOR PLATFORMS

INDUSTRIALISATION

Phillips Medisize

DESIGNING FOR SCALE: RELIABLE MANUFACTURING OF PEN INJECTOR PLATFORMS

Henrik Leisner discusses the reliable scaling of pen injector programmes, considering how high-quality, high-volume manufacture depends on experience and collaboration.

INDUSTRIALISING DRUG DELIVERY DEVICES: INSIGHTS FROM 40 YEARS OF GETTING TO MARKET

Chris Hurlstone

INDUSTRIALISING DRUG DELIVERY DEVICES: INSIGHTS FROM 40 YEARS OF GETTING TO MARKET

Chris Hurlstone looks at the process of developing drug delivery systems through the industrialisation phase and explores ways to address the challenges that arise along the way. Drawing on Team’s 40-year track record of supporting drug delivery device innovation, the insights are intended for teams involved in developing drug delivery systems, particularly those responsible for design, engineering, industrialisation and manufacturing transfer.

INDUSTRIALISING DRUG DELIVERY IN AN UNCERTAIN WORLD

INDUSTRIALISATION

INDUSTRIALISING DRUG DELIVERY IN AN UNCERTAIN WORLD

Andy Wertheim considers how the priorities of drug delivery device industrialisation have shifted in response to the major supply chain shocks of recent years, with companies shifting their focus from purely optimising for low cost and putting much greater emphasis on security and continuity, and what these changing priorities imply for the industry as a whole.

FLYING ON TWO WINGS: YPSOMED’S DUAL-ENGINE STRATEGY FOR SUCCESS IN CHINA

INDUSTRIALISATION

FLYING ON TWO WINGS: YPSOMED’S DUAL-ENGINE STRATEGY FOR SUCCESS IN CHINA

Hong Cui, Orfeo Niedermann and Shawn James discuss how Ypsomed has succeeded in China, highlighting the importance of integrating into the local market, keeping in stride with the pace of development and maintaining alignment with global quality standards.

DE-RISKING POST-MARKET CHANGE THROUGH PILOT PRODUCTION

DE-RISKING POST-MARKET CHANGE THROUGH PILOT PRODUCTION

Jon Powell explores how pilot production, delivered through integrated design, development and manufacturing capabilities, can be used to de-risk change in commercial-scale drug delivery devices, highlighting how such approaches can improve confidence in decision-making while reducing overall time and cost.

HOW MODERN PROTOTYPING ACCELERATES DRUG DELIVERY DEVICE DEVELOPMENT

INDUSTRIALISATION

Erwin van Huijksloot

HOW MODERN PROTOTYPING ACCELERATES DRUG DELIVERY DEVICE DEVELOPMENT

Erwin van Huijksloot and Joe Melton discuss the importance of early prototyping, ensuring a strong understanding of production efficiency and possible variability is grasped before large-scale manufacture begins.

Technology Showcase: DIGITAL TWIN TECHNOLOGY FOR AUTOINJECTORS

Technology Showcase: DIGITAL TWIN TECHNOLOGY FOR AUTOINJECTORS

To Issue 188 Citation: “Technology Showcase: Covestro – Digital Twin Technology for Autoinjectors”, ONdrugDelivery, Issue […]

EFFICIENCY, DATA INTEGRITY AND QUALITY ASSURANCE IN THE PRODUCTION OF INSULIN PENS

EFFICIENCY, DATA INTEGRITY AND QUALITY ASSURANCE IN THE PRODUCTION OF INSULIN PENS

Stephan Vogel discusses the role of advanced monitoring technologies in high-volume medical device manufacturing, considering the key role they play in ensuring quality and compliance with regulatory requirements and how analysing data centrally can support consistency across lines and sites.

Testing Prefilled Syringes to ISO 11040

Landon Goldfarb

Testing Prefilled Syringes to ISO 11040

Instron's Landon Goldfarb talks through ISO 11040, a testing standard that addresses the design and functional properties of prefilled syringes.

ROLLER COMPACTION IN MODERN ORAL SOLID DOSE DEVELOPMENT

David O’Connell

PCI Pharma Services

ROLLER COMPACTION IN MODERN ORAL SOLID DOSE DEVELOPMENT

David O’Connell delves into oral solid dosage production, highlighting the advantages of roller compaction for sensitive drugs as well as the possibilities for integration into existing manufacturing lines.

ORAL DELIVERY OF MACROMOLECULES: CHALLENGES AND OPPORTUNITIES FOR DEVICE-ENABLED GI DELIVERY

Dr Sahab Babaee

ORAL DELIVERY OF MACROMOLECULES: CHALLENGES AND OPPORTUNITIES FOR DEVICE-ENABLED GI DELIVERY

Dr Sahab Babaee discusses the potential of device-based approaches to enable the delivery of macromolecules via the gastrointestinal tract, considering the constraints and possibilities of mucosal delivery devices, as well as the technologies currently being investigated to make this potential a reality.

INTELLIGENT INTEGRATION: WHY CONNECTED OSD ECOSYSTEMS ARE RESHAPING PHARMACEUTICAL MANUFACTURING

INTELLIGENT INTEGRATION: WHY CONNECTED OSD ECOSYSTEMS ARE RESHAPING PHARMACEUTICAL MANUFACTURING

Borja Guerra delves into how the oral solid dosage manufacturing industry is being reshaped by connected machinery, advanced digital systems and integrated supplier ecosystems across the production process.

ADVANCING ORAL BIOLOGIC DELIVERY: OVERCOMING BARRIERS TO ENABLE INNOVATION AND ACCESS

Dr Vincent Jannin

ADVANCING ORAL BIOLOGIC DELIVERY: OVERCOMING BARRIERS TO ENABLE INNOVATION AND ACCESS

Dr Vincent Jannin considers the advantages of delivering biologic medications, including glucagon-like peptide-1s, via oral delivery and discusses the technological strides being made towards enabling biologics to shift away from parenteral delivery.

Interview: Celebrating 10 Years of Molly Enabling Patients’ Independence

Nicholas Heaton

Interview: Celebrating 10 Years of Molly Enabling Patients’ Independence

Nicholas Heaton looks back on the decade since Molly – SHL Medical’s signature two-step autoinjector platform – was launched onto the market, reviewing what made the device platform a success, where Molly is positioned in the market today and how it will continue to evolve to meet the demands of the future.

Interview: GLP-1 Demand and the New Reality of Device Manufacturing Capacity

Interview: GLP-1 Demand and the New Reality of Device Manufacturing Capacity

Andy Wertheim discusses the growing shortage of available manufacturing capacity driven by the boom in GLP-1 therapies, why this means mid-volume development programmes across a range of sectors are struggling to move from development to industrialisation, and how Quvara Medical is ideally positioned to provide the capacity that these programmes lack.

CLOSING THE SAFETY GAP: WHY PHARMA-DEDICATED LABELS MATTER

INDUSTRIALISATION

Paavo Sillanpää

UPM Adhesive Materials

CLOSING THE SAFETY GAP: WHY PHARMA-DEDICATED LABELS MATTER

Paavo Sillanpää discusses why pharma-dedicated labels matter for more challenging labelling applications as well as how to avoid potential label failure and brand risk.

ADVANCING AUTOINJECTOR PLATFORMS FOR EVOLVING DRUG AND PATIENT NEEDS

Martin Høier Thomsen

ADVANCING AUTOINJECTOR PLATFORMS FOR EVOLVING DRUG AND PATIENT NEEDS

Martin Høier Thomsen introduces MGS’s A.i.r. Platform™ within the broader context of the evolution of autoinjector platforms towards more adaptable, customisable solutions. He considers how next-generation autoinjector platforms can address increasingly complex and changing demands, while helping to mitigate risk and prioritise usability.

DELIVERABILITY, ACCEPTABILITY, AVAILABILITY: ASSESSING THE EVOLVING STRENGTHS OF MICRONEEDLE-BASED DRUG DELIVERY

DELIVERABILITY, ACCEPTABILITY, AVAILABILITY: ASSESSING THE EVOLVING STRENGTHS OF MICRONEEDLE-BASED DRUG DELIVERY

Dr May Pidding explores the growth and future potential of microneedle technology and its suitability for a broad range of drug delivery applications, specifically presenting the case for the accelerated uptake and wider adoption of Microneedle Array Patch (MAP) technology.

IMPORTANCE OF BEING PATIENT-CENTRIC IN CARDIOVASCULAR-KIDNEY-METABOLIC CARE

IMPORTANCE OF BEING PATIENT-CENTRIC IN CARDIOVASCULAR-KIDNEY-METABOLIC CARE

Cécile Gross and Mark Tunkel discuss Nemera's substantial portfolio of user-friendly, effective injectable devices available to meet the needs of patients with diverse chronic conditions.

DEORA™: FILLING THE GAP FOR MULTI-USE, FIXED-DOSE INJECTION SOLUTIONS

Stevanato Group

DEORA™: FILLING THE GAP FOR MULTI-USE, FIXED-DOSE INJECTION SOLUTIONS

Manuela Giacon explores the evolution of handheld drug delivery devices, leading up to today’s challenges, and presents the company’s latest addition to its drug delivery portfolio.

LVSC DELIVERY: HOW VOLUME AND CONCENTRATION REQUIREMENTS ARE RESHAPING DEVICE SELECTION

Phillips Medisize

LVSC DELIVERY: HOW VOLUME AND CONCENTRATION REQUIREMENTS ARE RESHAPING DEVICE SELECTION

Tony Bedford considers how the rise in biologic formulations together with a strong shift towards subcutaneous administration is shaping the drug delivery industry, particularly in relation to large-volume subcutaneous delivery.

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