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Prefilled Syringes & Injection Devices Drug Delivery A NEW HIGH- WORLD’S FIRST HOW TO DESIGN PERFORMANCE TOTALLY SILICONE-FREE A BODY-WORN P14 AUTOINJECTOR P18 GLASS PFS SYSTEM P61 INJECTOR PREFILLED SYRINGES & INJECTION DEVICES OUTSTANDING ISSUE SPONSOR 105 O 2020 • ISSUE N 2020 TH FEBRUARY 5 FEBRUARY Pharmapack 2020 Stand: G50 Helping our clients achieve success through great product design www.dca-design.com Pharmapack 2020 Stand: G50 Helping our clients achieve success through great product design www.dca-design.com INTRODUCING DATWYLER’S NEXTGENERATION COATED PLUNGER: NEOFLEX™ Datwyler’s range of NeoFlex™ plungers offers a robust packaging solution for the prefilled syringe and cartridge markets, taking into account the need for superior functionality and exceptional compatibility. Coated with Datwyler‘s proprietary spray coating techno- logy, NeoFlexTM plungers are the ideal so- lution for your drug product needs. At Datwyler, we help to improve patients‘ lives – because we care. www.sealing.datwyler.com See the Companion® and the Connect™ Auto-Sensing Injection System at Pharmapack Stand E59 and in the Innovation Gallery Contents ONdrugDelivery Issue No 105, February 5th, 2020 Addressing Complex Biologics with Rational Drug Device Design Gene Rhode Fuensalida Pantig, RPh, Resident Molecular Biologist & Pharmacist PREFILLED SYRINGES & INJECTION DEVICES 08 -12 SHL Group This edition is one in the ONdrugDelivery series Development of a New High-Performance Autoinjector of publications from Frederick Furness Publishing. Tom Oakley, Director of Drug Delivery Device Development Each issue focuses on a specific topic within the Springboard 14 - 17 Sigrid Saaler-Reinhardt, Director of Corporate Project Management field of drug delivery, and is supported by industry Midas Pharma leaders in that field. Finding the Right Packaging for Biologic Drugs EDITORIAL CALENDAR 18 - 20 Christian Helbig, Head of Glass Syringes Apr 2020 Pulmonary & Nasal Drug Delivery SCHOTT May Injectable Drug Delivery How Users Distinguish Self-Injection Device Platform Variants Jun Connecting Drug Delivery 24 - 28 Andreas Schneider, Innovation & Business Development Manager Jul Novel Oral Delivery Systems Ypsomed Aug Industrialising Drug Delivery Leveraging the Patient Journey to Optimise Device use at Home Sep Wearable Injectors Séverine Duband, Global Category Manager Oct Prefilled Syringes & Injection Devices 30 - 34 Nemera Nov Pulmonary & Nasal Drug Delivery Mark Tunkel, Director of Business Development, Insight Innovation Center Dec Connecting Drug Delivery Nemera Insight Innovation Center Jan 2021 Skin Drug Delivery: Enhancing the Patient Experience for Self-Injection Systems Dermal, Transdermal & Microneedles 36 - 39 Joe Reynolds, Research Manager Feb Prefilled Syringes & Injection Devices Noble Addressing the Evolving Needs of Variable Drug Delivery Regimens EDITORIAL: Temitope Sodunke, Strategic Innovation Leader Guy Furness, Proprietor & Publisher 42 - 45 BD Medical – Pharmaceutical Systems T: +44 1273 47 28 28 E: [email protected] Large-Volume Injectors: Rise in Biologics Brings Challenges Paolo Fiorini, Senior Design Engineer SUBSCRIPTIONS: Gerard Linnane, Director of Engineering Services Audrey Furness, Marketing Executive Michael Keily, Senior Device Development Engineer 47 - 50 Joshua Coyne, Design Engineer; and E: [email protected] Maciej Grygorczuk, Design Control Specialist 10-12 issues of ONdrugDelivery published Jabil Healthcare per year, in print and digitally. Print + Digital subscription: £99/year + postage. Drug Delivery Designed to Improve the Patient Experience Digital Only subscription: free. Jennifer King, Marketing Manager 52 - 55 Enable Injections ADVERTISING: Next-Generation Wearable Delivery Devices for Large-Volume Biologics Guy Furness, Proprietor & Publisher Thomas Mayer, Business Development Manager T: +44 1273 47 28 28 56 - 59 Sonceboz E: [email protected] How to Design a Body-Worn Injector Stephen Augustyn, Head of Mechanical Engineering Group MAILING ADDRESS: 61 - 64 Team Consulting Frederick Furness Publishing Ltd The Candlemakers, West Street, Lewes Product Showcase: ZwickRoell Parenteral Device Testing Platform East Sussex, BN7 2NZ, United Kingdom Wolfgang Moersch, International Marketing Manager 66 ZwickRoell ONdrugDelivery is published by The Need For CSTDs in Both Manual and Automated Compounding Frederick Furness Publishing Ltd 68 - 71 Marino Kriheli, Co-Founder Registered in England: No 8348388 Equashield VAT Registration No: GB 153 0432 49 The Challenges of a Changing Market & the Benefits of Development Flexibility ISSN 2049-145X print / ISSN 2049-1468 pdf David Fink, Vice-President Strategic Development; and 74 - 76 Sheila Trgovac, Head of Strategic Project Management Copyright © 2020 Frederick Furness Publishing Ltd Ximedica All rights reserved OXYCAPT™ Multilayer Plastic Vial and Syringe Shota Arakawa, Assistant Research Manager; and 79 - 82 Tomohiro Suzuki, Associate General Manager Mitsubishi Gas Chemical Prefilled Safety Syringe Market Thrives Amid Self-Administration Trend George I’ons, Head of Product Strategy and Insights 86 - 87 Owen Mumford Choosing the Right Label Material for Prefilled Syringes Jos van Noort, Principal Scientist, Global Pharma Applications The ONdrugDelivery logo is a registered trademark of 88 - 90 Avery Dennison Frederick Furness Publishing Ltd. EU MDR: Ancillary Delivery Devices Face Equal The views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher Scrutiny to Standalone Medical Devices makes no claim that it is free of error. Nor does the publisher accept 91 - 92 Elizma Parry, Director, Global Clinical Practice liability for the consequences of any decision or action taken (or not Maetrics taken) as a result of any information contained in this publication. SHL Group ADDRESSING COMPLEX BIOLOGICS WITH RATIONAL DRUG DEVICE DESIGN In this article, Gene Rhode Fuensalida Pantig, RPh, Resident Molecular Biologist and Pharmacist at SHL Medical, reviews drug development over the years, the discovery of biologics as therapeutic agents and the emergence of autoinjectors. In correspondence, Hans Lin, PhD, a Research Fellow from Academia Sinica in Taiwan – who has interests in protein biology and drug discovery – discusses the inherent properties of biologics that should be of prime consideration to pharma companies and drug delivery device developers. With complex biologics moving the field of medicine further into a more personalised approach, the article also discusses the need for an even tighter collaboration from drug research through to development of the combination product. The many advances in molecular biology target. For a compound to be considered and biotechnology – from the advent of a lead in rational drug discovery, a classic recombinant DNA technology to the use requirement would be to satisfy Lipinski’s of panomics1 – have significantly furthered “rule of five” (Ro5).3 our understanding of the human body’s The Ro5 is a set of physicochemical molecular landscape. At present, scientists properties that allows the compound to be and clinicians steer the direction to absorbed in the gastrointestinal system.4,5 deliver not just targeted but also truly In general, the rule outlines that a lead personalised medicine. compound should be relatively small in This targeted approach in medicine molecular size and, owing to its chemical has come a long way. From the classic properties, lipophilic in nature. While the antibiotics and antineoplastics, non-selective rule has always been considered to determine cytotoxic drug classes that often involve the fate of whether a drug can even reach its adverse effects for patients, we now shift site of action, most compounds that do not to biologics – therapeutic molecules which satisfy it are left unstudied. try to correct biochemical pathways or inhibit aberrant cells or proteins. Alongside ORAL SMALL-MOLECULE DRUGS the development of biologics is the need AND THE DRUGGABILITY DILEMMA to develop novel delivery systems that not only consider the molecule but also the end Druggability,6 on the other hand, refers to receivers of drug therapy – the patients. As the likelihood of a target – oftentimes a well as the standard prefilled syringes for the protein involved in disease states – being Gene Rhode Fuensalida Pantig, RPh assisted administration of biologics, recently modulated by a drug. Thus, while a potential Resident Molecular Biologist and developed prefilled pen and autoinjectors drug may be considered absorbable, Pharmacist, SHL Medical for patient self-administration have also it must then bind to its druggable target at T: +886 3 217 0303 Ext. 1416 found their space in molecular medicine.2 E: [email protected] THE CLASSICAL APPROACH TO SHL Group DRUG DISCOVERY AND DESIGN “Of the many challenges No 36, Liufu Road in delivering precision Luzhu District In the past, drug development and discovery Taoyuan City medicine, the drug itself is 338 Taiwan have mainly focused on small molecules, Republic of China primarily owing to their oral bioavailability still the rate-limiting step.” and their affinity to bind a druggable shl.group 8 www.ondrugdelivery.com Copyright © 2020 Frederick Furness Publishing Ltd SHL Group the site of action. This binding is expected viscous in terms of their chemical and to elicit a cascade of events, eventually “With only around 10% physical nature. In a discussion with SHL alleviating disease conditions – at least at
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