Aptar Pharma

INDUSTRIALISATION

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?

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.

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.

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.

CONTINUOUS IMPROVEMENT: FROM ABSTRACTION TO REALITY

INDUSTRIALISATION

CONTINUOUS IMPROVEMENT: FROM ABSTRACTION TO REALITY

Tracy Pedreso discusses SHL Medical’s strategy for making continuous improvement a reality.

SINGLE USE SYSTEMS – THE FUTURE OF BIOPHARMACEUTICAL PROCESSING

SINGLE USE SYSTEMS – THE FUTURE OF BIOPHARMACEUTICAL PROCESSING

Jeff Lowe considers single-use systems and looks at their role in the future of biopharmaceutical processing.

DISSECTING THE DELICATE DELIVERY PROCESS FOR OCULAR GENE THERAPY

Dr Yongdong Zhou

DISSECTING THE DELICATE DELIVERY PROCESS FOR OCULAR GENE THERAPY

Yongdong Zhou considers the challenges of ocular gene therapy delivery approaches.

HOLISTIC DEVELOPMENT & INDUSTRIALISATION OF DRUG DELIVERY DEVICES & COMBINATION PRODUCTS

INDUSTRIALISATION

HOLISTIC DEVELOPMENT & INDUSTRIALISATION OF DRUG DELIVERY DEVICES & COMBINATION PRODUCTS

Mark Tunkel and Niyati Sapatnekar discuss Nemera’s holistic approach to development and industrialisation.

INTERVIEW: Piyush Agarwal, Tjoapack

INTERVIEW: Piyush Agarwal, Tjoapack

Piyush Agarwal talks with ONdrugDelivery about the current state of the injectable pharmaceuticals market and how working with a specialist contract packaging organisation can help pharma companies navigate their product through this rapidly evolving sector and deliver their product to market on time.

NEXT-GENERATION CAPSULE FILLING: MG2 AND THE DM² PROJECT

INDUSTRIALISATION

NEXT-GENERATION CAPSULE FILLING: MG2 AND THE DM² PROJECT

MG2 introduces the UK Made Smarter Innovation - Digital Medicine Manufacturing (DM²) Research Centre, which it has recently joined as an industrial partner, and describes how it will develop an AI-driven microscale capsule filling system for the selection of formulation and process parameters.

PUTTING PROCESS ENGINEERING INTO ACTION

Jonathan Kearns

PUTTING PROCESS ENGINEERING INTO ACTION

Jonathan Kearns and Kevin Huang consider how engineering competencies are being driven to the next level by leveraging process engineering and how this can transform drug-device projects.

GLASS-FILLED CELANEX<sup>®</sup> MT<sup>®</sup> PBT HITS SWEET SPOT FOR BIOLOGICS AND REUSABLE DEVICES

GLASS-FILLED CELANEX^® MT^® PBT HITS SWEET SPOT FOR BIOLOGICS AND REUSABLE DEVICES

Bryan Deacon, Marnik Vaes and Peter Burke, introduce a medical-grade glass-filled engineering polymer, Celanex^® MT^® PBT 2406MT GF20, which fills a gap in the materials market between standard engineering thermoplastics and expensive high-performance polymers.

RECENT TRENDS & DEVELOPMENTS IN INJECTABLE FORMULATION & DELIVERY

Dr Martin Gonzalez

RECENT TRENDS & DEVELOPMENTS IN INJECTABLE FORMULATION & DELIVERY

Martin Gonzalez details current trends in sterile injectable formulations and their delivery devices, and the challenges pharma and its contract development and manufacturing company partners face in bringing emerging breakthroughs to market.

SMART SOLUTIONS TO REDUCE CARBON FOOTPRINT

SMART SOLUTIONS TO REDUCE CARBON FOOTPRINT

Rob Doorakkers and Geert van Amstel discuss why the company decided to become carbon neutral, how it is working to make injection moulding more sustainable and how the organisation is minimising its impact on the environment.

DESIGNING DRUG DELIVERY DEVICES TO MEET EMERGING NEEDS AND SUSTAINABILITY GOALS

Dr Pierre Moulinie

DESIGNING DRUG DELIVERY DEVICES TO MEET EMERGING NEEDS AND SUSTAINABILITY GOALS

Pierre Moulinié, Isaac Platte and Lauren Zetts discuss how polycarbonate-based materials deliver value to emerging drug delivery devices.

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