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INDUSTRIALISATION

COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES
INJECTION
Dr Matthias Bicker
SCHOTT Pharma
COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES
Matthias Bicker, Michael Müller, Marc Mittermüller, Daniel Haines and Uwe Rothhaar discuss the regulatory requirements that need to be considered when designing an extractables and leachables study for a drug product or medical device. To illustrate the subject further, the authors provide two example studies, each following a different set of regulatory guidelines.
STATE-OF-THE-ART SOLUTIONS FOR OPHTHALMIC STERILE DRUG PRODUCT MANUFACTURING
OCULAR
Rainer Glockler
ten23 health
STATE-OF-THE-ART SOLUTIONS FOR OPHTHALMIC STERILE DRUG PRODUCT MANUFACTURING
In the first in a series of two articles, Rainer Glöckler and Carole Delauney discuss how the company’s state-of-the-art filling line meets the requirements and complexities that are particular to ophthalmic drug product manufacturing. The second article, to be published in May, will explore partnerships between pharma, CDMOs and syringe manufacturers in more detail.
LINKING THE “D” & “M” IN CDMO
EXPERT VIEW
Mr John Ross
LINKING THE “D” & “M” IN CDMO
John Ross looks at the role of CDMOs in product development through to commercialisation and considers the benefits of consolidated “DM” models.
INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY
INTERVIEW
Benjamin Dietiker
INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY
Benjamin Dietiker, Weidmann Medical Technology, talks with ONdrugDelivery about how the company has successfully implemented a growth strategy by focusing on key areas, plans for expansion, the effect of covid-19 on the business, and how the company differentiates itself from larger competitors by focusing on quality and service.
STEVANATO & EITAN BRING NEXT-GENERATION WEARABLE DRUG DELIVERY SOLUTIONS TO MARKET
WEARABLES
Chiara Mussoi
Stevanato Group
STEVANATO & EITAN BRING NEXT-GENERATION WEARABLE DRUG DELIVERY SOLUTIONS TO MARKET
Chiara Mussoi, Riccardo Prete and Mindy Katz outline the benefits of collaboration when it comes to bringing wearable drug delivery solutions to market.
HOW TO KEEP THE GRANDFATHER DILEMMA FROM INTERRUPTING DRUG REDEVELOPMENT
INJECTION
Chris Rojewski
Pfizer CentreOne
HOW TO KEEP THE GRANDFATHER DILEMMA FROM INTERRUPTING DRUG REDEVELOPMENT
Chris Rojewski provides programme insights into approval pathways for the redevelopment of pharmaceutical compounds.
MEDICAL DEVICE DESIGN STRATEGY FOR A CONNECTED FUTURE
CONNECTIVITY
Mr Michael Kiely
Jabil Healthcare
MEDICAL DEVICE DESIGN STRATEGY FOR A CONNECTED FUTURE
Michael Kiely, Laura Marsden, Peter Stringer, and David Boyle discuss the design challenges at the electromechanical interface and encourage manufacturers to adopt a standardised approach for connecting medical devices to the cloud.
AN ADVANCED CUSTOMISABLE COMPREHENSIVE DPI CAPSULE PORTFOLIO OFFERING
PULMONARY
Frédérique Bordes-Picard
Lonza
AN ADVANCED CUSTOMISABLE COMPREHENSIVE DPI CAPSULE PORTFOLIO OFFERING
Frédérique Bordes-Picard and Julien Lamps discuss the factors driving development in the area of capsule-based dry powder inhalers, and how the company’s Capsugel® Zephyr™ portfolio offering is perfectly positioned to meet and exceed industry’s growing and evolving requirements.
DEVELOPMENT & PRODUCTION OF RESPIMAT<sup>®</sup> REUSABLE INHALER HOUSING MODULE
RESPIRATORY
Josef Schmid
Gerresheimer
DEVELOPMENT & PRODUCTION OF RESPIMAT® REUSABLE INHALER HOUSING MODULE
Josef Schmid, Markus Müller and Nina Zielonka discuss Gerresheimer’s recent work on developing the housing module for Boehringer Ingelheim’s new version of the Respimat inhaler.
ONE-STOP SHOP FOR TOTAL MIXING SOLUTIONS FOR PHARMACEUTICAL MANUFACTURERS
INDUSTRIALISATION
Bert Dekens
ONE-STOP SHOP FOR TOTAL MIXING SOLUTIONS FOR PHARMACEUTICAL MANUFACTURERS
Bert Dekens discusses Hosokawa Micron's offering for pharmaceutical powder mixing, including the Cyclomix high-shear mixer and the Nauta low-shear mixer, and how the company’s technology solutions take a broader approach to the full mixing process than simply providing a mixing machine.
COLD FILLING VERSUS PRESSURE FILLING: THE CASE FOR VERSATILE, FULLY INTEGRATED CDMOs
RESPIRATORY
Steve Haswell
Kindeva
COLD FILLING VERSUS PRESSURE FILLING: THE CASE FOR VERSATILE, FULLY INTEGRATED CDMOs
Steve Haswell compares the two main processes for manufacturing pressurised metered dose inhalers – and examines the value for pharmaceutical companies of working with contract development and manufacturing organisations that have expertise in both processes.
PULMO<emp>CRAFT</emp>™: ENGINEERING SPRAY-DRIED POWDERS FOR PULMONARY DELIVERY
PULMONARY
Dr Richard Johnson
Upperton Pharma Solutions
PULMOCRAFT™: ENGINEERING SPRAY-DRIED POWDERS FOR PULMONARY DELIVERY
Richard Johnson discusses the techniques of jet milling and spray drying for the production of formulations for dry powder inhalers, and introduces Upperton Pharma’s PulmoCraft™ technology, which combines the advantages of both.
MG2 AUTOMATION SOLUTIONS FOR INHALATION: R&D, TECHNOLOGICAL PARTNERSHIPS & SUCCESSFUL CASE HISTORIES
PULMONARY
MG2
MG2 AUTOMATION SOLUTIONS FOR INHALATION: R&D, TECHNOLOGICAL PARTNERSHIPS & SUCCESSFUL CASE HISTORIES
Italian automation solutions provider MG2 describes its offering in the inhalation space, including unique benefits of collaboration and two example partnerships.
THE “CUSTOMISABLE PLATFORM” PARADOX
INDUSTRIALISATION
Lyndon Wild
SHL Medical
THE “CUSTOMISABLE PLATFORM” PARADOX
Lyndon Wild and Gene Rhode Fuensalida Pantig present a systematic analysis of the customisable platform architecture found in the Molly® autoinjector technology.
LEVERAGING INTEGRATION THROUGHOUT A DRUG DELIVERY SYSTEM PROJECT
INDUSTRIALISATION
Steven Kaufman
Stevanato Group
LEVERAGING INTEGRATION THROUGHOUT A DRUG DELIVERY SYSTEM PROJECT
Steven Kaufman and Adam Stops describe how an integrated offering can help customers at each phase of a drug delivery system project.
VERIFICATION OF INJECTABLES IN TRANSPORT AND STORAGE
PREFILLED SYRINGES
Mark Turner
Medical Engineering Technologies
VERIFICATION OF INJECTABLES IN TRANSPORT AND STORAGE
Mark Turner discusses the regulations and requirements around testing combination products for their stability in storage over their shelf-life and during transport.
PACKAGING LINE FOR GSK AUTOINJECTORS: A CASE STUDY
INDUSTRIALISATION
Ivan De Sanzo
PACKAGING LINE FOR GSK AUTOINJECTORS: A CASE STUDY
Ivan De Sanzo describes a unique automated complete packaging line provided to GlaxoSmithKline for three different autoinjectors.
INTERVIEW: ERIK HAEFFLER, RECIPHARM
INTERVIEW
Erik Haeffler
Recipharm
INTERVIEW: ERIK HAEFFLER, RECIPHARM
In this interview, Erik Haeffler discusses how the pharma industry can balance optimising environmental sustainability with maintaining the highest safety and efficacy standard for achieving its main objective of promoting patient health and wellbeing.
INNOVATION AND AUTOMATION IN TOPICAL FORMULATION DEVELOPMENT
INDUSTRIALISATION
Prof Marc Brown
MedPharm
INNOVATION AND AUTOMATION IN TOPICAL FORMULATION DEVELOPMENT
Marc Brown, Jon Lenn and Charles Evans discuss the challenges faced by the pharmaceutical industry during the development of topical delivery formulations, and how MedPharm’s performance testing models help identify and mitigate risks during the process.
FROM FORMULATION TO MANUFACTURING: LIPID NANOPARTICLE mRNA VACCINES, GENE THERAPIES & OTHER NANOMEDICINES
INDUSTRIALISATION
Stephen Allan
Evonik
FROM FORMULATION TO MANUFACTURING: LIPID NANOPARTICLE mRNA VACCINES, GENE THERAPIES & OTHER NANOMEDICINES
Stephen Allan reviews the history and formulation advantages of lipid nanoparticles (LNPs) and addresses factors that should be considered by pharmaceutical companies during the CDMO selection process to help reduce regulatory risk, improve product performance and accelerate speed to market.
INTERVIEW WITH AARON MANN, CHIEF EXECUTIVE OFFICER, KINDEVA
INTERVIEW
Aaron Mann
INTERVIEW WITH AARON MANN, CHIEF EXECUTIVE OFFICER, KINDEVA
In this exclusive interview with ONdrugDelivery, Aaron Mann discusses how Kindeva is positioned to move forward as a major CDMO specialising in inhalation and transdermal dosage forms, having been formed from 3M’s drug delivery in May 2020. We also cover the impact of Covid-19, environmental sustainability, and current challenges faced by the pharmaceutical industry.
ROUNDTABLE: JEREMY DRUMMOND, MEDPHARM; STEPHEN RODE, LONZA; AND TORKEL GREN, RECIPHARM
ROUNDTABLE
Dr Jeremy Drummond
ROUNDTABLE: JEREMY DRUMMOND, MEDPHARM; STEPHEN RODE, LONZA; AND TORKEL GREN, RECIPHARM
In this roundtable discussion, Jeremy Drummond, Stephen Rode and Torkel Gren discuss trends with different drug dosage forms for different routes of administration, the rise of patient centricity including the shift from the blockbuster model to more tailored products.
ADVANCED CAPSULE TECHNOLOGIES: DRY POWDER INHALERS TO TARGET DISEASE
EXPERT VIEW
Frédérique Bordes-Picard
ADVANCED CAPSULE TECHNOLOGIES: DRY POWDER INHALERS TO TARGET DISEASE
Frédérique Bordes-Picard  and Julien Lamps discuss the value of capsule-based dry powder inhalers in the modern respiratory market, the factors driving development in this area and considerations for matching a capsule to a device and formulation.
CUSTOMISING PLATFORM DEVICES: CHALLENGES & CONSIDERATIONS
INDUSTRIALISATION
Doug Boyd
CUSTOMISING PLATFORM DEVICES: CHALLENGES & CONSIDERATIONS
How do you choose the best delivery system for your drug? Doug Boyd explores the pros and cons of a cost-effective, off-the-shelf platform versus a custom drug delivery device, and discusses the challenges and considerations of customising an existing platform device.
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