FORMULATION & PATIENT CENTRICITY: DRIVERS FOR DEVICE DEVELOPMENT: THE IMPORTANCE OF HUMAN CHANGE IN ASEPTIC P30 A SYMBIOTIC RELATIONSHIP P34 FACTORS IN THE PANDEMIC ERA P74 AUTOMATION INJECTABLE DRUG DELIVERY 120 O 2021 • ISSUE N 2021 ST MAY 31 MAY The world needs you to succeed. Let us help you get there faster, and safely. Only a few ever reach the summit – those who possess the right combination of intelligence, resilience, bravery, and respect – backed up by a team of experienced and expert partners. As the challenge to deliver COVID-19 related vaccines and treatments continues, you can count on Aptar Pharma to help you achieve your goal. Our PremiumCoat® fi lm-coated solutions can help derisk your drug development and support the specifi c needs of your COVID-19 projects. PremiumCoat® stoppers, our proven multidose vial containment solution, can reliably accommodate up to 20 piercings, enabling HCPs to vaccinate and treat more people, more effi ciently. Our platform approach with PremiumCoat® 1mL long and 1-3mL syringe plungers facilitates your transition to Pre-Filled Syringes to anticipate long term vaccination strategies. Aptar Pharma. Enabling the rapid deployment of your vaccines worldwide. To reach the summit faster, and with less risk, contact Estelle Verger, Business Development Senior Manager, Aptar Pharma, at [email protected] Delivering solutions, shaping the future. 21037 APTAR - May ONDD PremiumCoat ad@A4 ONdrugDelivery.indd 1 23/04/2021 15:15 Collaborate with Pfizer CentreOne, and Intelligent collaboration with access Pfizer’s global sites and experts, Pfizer CentreOne. ready to support your sterile injectables’ Our collaborative approach means more toughest go-to-market challenges. efficient routes to market, high-quality sterile injectables and long-term supply assurance. Listening. Solving. Guiding. We’ve been helping our partners overcome Welcome to Pfizer CentreOne. We’re a global many technical challenges for over 40 years. CDMO embedded within Pfizer and a leader You can count on us to carefully guide your in sterile injectables. compound from development through to commercial manufacture. Lets collaborate Visit us at www.pfizercentreone.com We’re known for our expertise in: • Complex biologics • Controlled substances (II-IV) • Lyophilization • Sterile suspensions Contents ONdrugDelivery Issue No 120, May 31st, 2021 How to Ensure the Future Demand for Biologics Can Still be Delivered by Injectables INJECTABLE DRUG DELIVERY Anthony Vico, Technical Customer Support & Quality Management Supervisor; and 08 -12 Enrico Barichello, Product Management Specialist for Syringes and Components This edition is one in the ONdrugDelivery series Stevanato Group of publications from Frederick Furness Publishing. From Process to Product: Optimising Process Development Each issue focuses on a specific topic within the Strategies for Variable Drug-Device Requirements field of drug delivery, and is supported by industry Markus Goldinger, Senior Director of Process Development; and 16 - 21 Erik Alexandersson, Assistant Manager of Process Development leaders in that field. SHL Medical EDITORIAL CALENDAR The Added Value of a Platform Approach: Pen Injector Case Study Radosław Romańczuk, Pen Platform Business Development Director; Jun 2021 Connecting Drug Delivery Severine Duband, Category Director, Devices; and Jul Novel Oral Delivery Systems 24 - 28 Audrey Chandra, Category Project Manager Aug Industrialising Drug Delivery Nemera Sep Wearable Injectors Formulation & Device Development: a Symbiotic Relationship Sep/Oct Drug Delivery & Environmental Sustainability 30 - 32 Caroline Zakrzewski, Drug Delivery Devices Scientist Oct Prefilled Syringes & Injection Devices Cambridge Design Partnership Nov Pulmonary & Nasal Drug Delivery Patient-Centricity: the Importance of Human Factors in the Pandemic Era Marcus Agunloye, Senior Human Factors Engineer & Industrial Designer Dec Connecting Drug Delivery Oval Medical Technologies Jan 2022 Skin Drug Delivery: 34 - 40 Asmita Khanolkar, Senior Director, Cambridge Pharma, Dermal, Transdermal & Microneedles SMC Technical Strategy & Commercialization Feb Prefilled Syringes & Injection Devices SMC Ltd. Mar Ophthalmic Drug Delivery Towards User-Centric Specification of Autoinjector Mar/Apr Drug Delivery & Environmental Sustainability Technical Attributes: Insights From Empirical Work 41 - 44 Andreas Schneider, Innovation & Business Development Director Apr Pulmonary & Nasal Drug Delivery Ypsomed May Injectable Drug Delivery: How Owen Mumford Carried Out Usability Formulations & Devices Testing Under Covid-19 Restrictions Miranda Newbery, Director and Founder EDITORIAL: 46 - 48 Inspired Usability Guy Furness, Proprietor & Publisher Finola Austin, Human Factors Engineering Manager E: [email protected] Owen Mumford Pharmaceutical Services Reusable Electronic Autoinjector – Flexible Performance CREATIVE DESIGN: Bjarne Sørensen, Director, Front-End Innovation 50 - 54 Phillips-Medisize Corporation Simon Smith, Creative Director (Freelance) E: [email protected] Addressing the Challenges of Viscous Injectable Administration Andrew Donnelly, Vice-President of Innovation Bespak by Recipharm SUBSCRIPTIONS: 56 - 59 Shahid Uddin, Director of Drug Product, Formulation & Stability Audrey Furness, Marketing Executive Immunocore E: [email protected] Subcuject WBI: Low-Cost, Larger Volume, High-Viscosity Wearable Print + Digital subscription: £99/year + postage. Bolus Injector – Using Standard Glass Primary Packaging Digital Only subscription: free. 60 - 62 Claus Schmidt Moeller, Chief Technology Officer Subcuject ADVERTISING: Safe and Automatic Device to Improve Drug Preparation from Multidose Vials Guy Furness, Proprietor & Publisher Benjamin Morel, Intellectual Property Manager; and E: [email protected] 64 - 66 Claire Authesserre, R&D Fluidics Manager EVEON ONdrugDelivery is published by Ensuring Functional Performance and Regulatory Compliance Frederick Furness Publishing Ltd of Elastomer Stoppers for Multipiercing Situations Bruno Morchain, Technical Center Manager, Aptar Pharma Injectables; The Candlemakers, West Street, Lewes 70 - 73 Sébastien Cordier, Technical Product Manager, PremiumCoat®; and East Sussex, BN7 2NZ, United Kingdom Estelle Verger, Business Development Senior Manager, PremiumCoat® T: +44 1273 47 28 28 Aptar Pharma Drivers for Change in Aseptic Automation Registered in England: Company No 8348388 Dave Seaward, Projects Director; and ISSN 2049-145X print / ISSN 2049-1468 pdf 74 - 79 David Phasey, Projects Director 3P innovation Copyright © 2021 Frederick Furness Publishing Ltd Ophthalmic Drugs: Pathway to Overcome Primary Packaging All rights reserved and Drug Product Manufacturing Challenges Rainer Glöckler, Chief Technical Officer; and Carole Delauney, Director Business Development 80 - 86 Swissfillon Nicolas Eon, Senior Technology Development Manager; and Katsuyuki Takeuchi, Associate Product Manager, Pharmaceutical Solutions Terumo Europe The ONdrugDelivery logo is a registered trademark of Frederick Furness Publishing Ltd. Comparative Extractable Studies for Injectables and Medical Devices Aligned with USP <1663> and ISO 10993 Guidelines The views and opinions expressed in this issue are those of the authors. Matthias Bicker, Scientific Advisor; Due care has been used in producing this publication, but the publisher Michael Müller, Study Director; makes no claim that it is free of error. Nor does the publisher accept 88 - 97 Marc Mittermüller, Study Director; liability for the consequences of any decision or action taken (or not Daniel Haines, Head of Pharma Services North America; and taken) as a result of any information contained in this publication. Uwe Rothhaar, Director Front cover image, “Medical syringe, illustration”, credit: VICTOR SCHOTT Pharma Services HABBICK VISIONS / SCIENCE PHOTO LIBRARY. Stevanato Group HOW TO ENSURE THE FUTURE DEMAND FOR BIOLOGICS CAN STILL BE DELIVERED BY INJECTABLES Here, Anthony Vico, Technical Customer Support & Quality Management Supervisor, and Enrico Barichello, Product Management Specialist for Syringes and Components, both of Stevanato Group, discuss the demands that high-viscosity biologic formulations place on prefilled syringes, and how pharmaceutical companies can make the most of this growing market segment to deliver improved quality of life for patients. Global biologic sales are expected to grow biologics are characterised by high from a market size of US$325 billion chemical sensitivity and strong dynamic (£230 billion) in 2020 to $425 billion characteristics (i.e. viscosity), which pose (£300 billion) by 2024. That represents significant challenges to PFS technology. an estimated compound annual growth As a leading provider of primary packaging rate (CAGR) of 7%, and a significant and drug delivery systems, Stevanato opportunity for pharmaceutical companies.1 Group is consistently challenging itself to Biotech drugs, especially monoclonal deliver best-in-class, optimised solutions to antibodies (mAbs) and recombinant improve patients’ lives. proteins, have enabled the pharma industry This article reviews the current state to treat incurable critical and chronic of the PFS market and discusses the diseases, such as osteoporosis, rheumatoid challenges associated with biologic drug Anthony Vico arthritis and hypercholesterolemia, delivery, before covering a case study on Technical Customer Support & meeting previously unmet needs and how to optimise needle design to