INJECTION

AUTOINJECTORS FOR LARGE-VOLUME SUBCUTANEOUS DRUG DELIVERY

Ian Thompson provides a summary of a recent literature review on subcutaneous administration with dose volumes greater than 1.0 mL, which examines how previous studies have addressed the limitations and considerations for designing and developing large-volume autoinjectors.

INDUSTRIALISATION

BIOLOGIC INTEGRITY: MEASURING AND MANAGING THE HIDDEN LEACHABLES RISK FROM PFS ADHESIVE

Enrico Barichello considers the often-overlooked influence of adhesive in the assembly of prefilled syringes and how the hidden risks can be managed and overcome.

TIPS AND TRICKS FOR IMPLEMENTING SUSTAINABILITY INITIATIVES

TIPS AND TRICKS FOR IMPLEMENTING SUSTAINABILITY INITIATIVES

Henryk Badack outlines Vetter's efforts to establish sustainable business practices.

THE EVOLUTION OF THE PHARMA ECOSYSTEM: PRODUCT PERFORMANCE NOW MEETS SUSTAINABILITY

Dr Bettine Boltres

West Pharmaceutical Services

THE EVOLUTION OF THE PHARMA ECOSYSTEM: PRODUCT PERFORMANCE NOW MEETS SUSTAINABILITY

Bettine Boltres and Shivani Polasani discuss how pharma can progress towards a more sustainable future, and consider the role that the collaboration between Corning and West Pharmaceutical Services can play in supporting pharma’s sustainability goals.

HOW LIFECYCLE ASSESSMENT SUPPORTS INSIGHT-DRIVEN SUSTAINABLE DESIGN

Paramesh Natarajan

HOW LIFECYCLE ASSESSMENT SUPPORTS INSIGHT-DRIVEN SUSTAINABLE DESIGN

Paramesh Natarajan, Shadi Bavar and Charlie Dean present the case for using screening lifecycle assessments to lead into more detailed targeted and comprehensive lifecycle assessments focused on the areas of greatest environmental impact, using a screening lifecycle assessment of a hypothetical body-worn injector as an example.

AN AUTOINJECTOR REVOLUTION: ADVANCED SIMULATION TECHNOLOGIES ENHANCING GLOBAL MANUFACTURING NETWORKS

INDUSTRIALISATION

Edwin Hendrawan

AN AUTOINJECTOR REVOLUTION: ADVANCED SIMULATION TECHNOLOGIES ENHANCING GLOBAL MANUFACTURING NETWORKS

Edwin Hendrawan, Yi-Chi Lu and Christian Walter set out how SHL is building simulation capabilities, and describe how simulation will propel the business forward on every level, from individual shop floors to overall global expansion planning, in order to be able to meet the growing and increasingly complex demands from both pharma customers and patients.

INTERVIEW with Jeff Henderson

INTERVIEW with Jeff Henderson

Jeff Henderson discusses the practice of outsourcing within the pharmaceutical industry. He considers factors that pharma and biopharma companies should consider when determining whether or not to outsource to a CDMO and many of the advantages that outsourcing can offer, especially to small- and medium-sized companies.

Interview with Claire Raynal-Olive & Pierre-Yves Favennec

Claire Raynal-Olive

Interview with Claire Raynal-Olive & Pierre-Yves Favennec

Claire Raynal-Olive and Pierre-Yves Favennec discuss the strategy and objectives of Aptar Pharma’s expansion programme of its global rubber component manufacturing, implementing advanced technology, increased capacity and local-for-local manufacturing capability.

AUTOMATING ASSEMBLY TO EXPEDITE TIME-TO-MARKET

INDUSTRIALISATION

Dr Dave Seaward

AUTOMATING ASSEMBLY TO EXPEDITE TIME-TO-MARKET

Dave Seaward discusses how 3P innovation takes a holistic approach to solving the technical challenges encountered by its clients and looks for opportunities to enhance the final product, enable efficient processing and support commercially viable manufacturing.

TERUMO GLOBAL PARENTERAL CDMO – INTEGRATED INNOVATION

INDUSTRIALISATION

Terumo Medical Care Solutions

TERUMO GLOBAL PARENTERAL CDMO – INTEGRATED INNOVATION

Michele Guasti discusses the advantages that Terumo’s parenteral CDMO brings to customers due to its position as a single service provider from formulation to final product and its intimate understanding of Terumo’s range of prefillable polymer syringes.

COMPANY SHOWCASE: PCI PHARMA SERVICES

INDUSTRIALISATION

PCI Pharma Services

COMPANY SHOWCASE: PCI PHARMA SERVICES

PCI Pharma Services showcases its portfolio of drug delivery-relevant solutions, including: sterile fill-finish and lyophilisation; drug-device combination product design and development; packaging for injectables; and Speedsolutions™ supply chain simplification, and highlights plans for expansion.

INTERVIEW: DOUG BRYANS, BRYLLAN & JOHN MERHIGE, CREDENCE

INTERVIEW: DOUG BRYANS, BRYLLAN & JOHN MERHIGE, CREDENCE

Douglas Bryans and John Merhige discuss the changing needs of drug developers around novel dual-chamber and ready-to-use drug delivery devices, capacity and the delivery of complete solutions from CDMOs and device developers, anchored around the recently announced partnership between Credence MedSystems and Bryllan to provide these critical services.

NEW EXTRACTABLES DATA FOR OXYCAPT™ MULTILAYER PLASTIC VIAL FOR BIOLOGICS & GENE/CELL THERAPY

PREFILLED SYRINGES

Hiroki Hasegawa

Mitsubishi Gas Chemical

NEW EXTRACTABLES DATA FOR OXYCAPT™ MULTILAYER PLASTIC VIAL FOR BIOLOGICS & GENE/CELL THERAPY

Hiroki Hasegawa and Tomohiro Suzuki review the properties of OXYCAPT™, Mitsubishi Gas Chemical’s multilayer material for primary biologic packaging, and share the data from the latest study on OXYCAPT’s extractables profile.

PRIMARY PACKAGING CONSIDERATIONS FOR SUPPORTING COMPLIANCE TO ANNEX 1 REVISION

PREFILLED SYRINGES

Edouard Pagnoud

PRIMARY PACKAGING CONSIDERATIONS FOR SUPPORTING COMPLIANCE TO ANNEX 1 REVISION

Edouard Pagnoud, Estelle Verger and Benjamin Brocco look at the new requirements associated with EMA GMP Annex 1 revision regarding injectable primary packaging for ensuring sterility and safety, and consider how Aptar's PremiumFill^® can reduce the risk of contamination and defects.

RISING TO THE REGULATORY EVIDENCE CHALLENGE FOR HIGH-QUALITY COMBINATION PRODUCTS

PREFILLED SYRINGES

Victoria Morgan

West Pharmaceutical Services

RISING TO THE REGULATORY EVIDENCE CHALLENGE FOR HIGH-QUALITY COMBINATION PRODUCTS

Victoria Morgan and Stacy Gates-Rector explore how West is supporting pharma companies with packaging challenges through the supply of high-quality prefillable syringe plungers and provision of a highly co-ordinated technical documentation package.

COMBINING PLASTIC BAG FLEXIBILITY WITH GLASS STORAGE STABILITY – NEXT-GENERATION PACKAGING FOR SENSITIVE PREMIXED DRUGS

Pauline Koyanagi

COMBINING PLASTIC BAG FLEXIBILITY WITH GLASS STORAGE STABILITY – NEXT-GENERATION PACKAGING FOR SENSITIVE PREMIXED DRUGS

Pauline Koyanagi and Atsushi Mio look at the benefits of flexible drug packaging and discuss ZACROS’s MediTect™ packaging for sensitive liquid parenteral formulations.

“A CHILD IS NOT A SMALL ADULT”: CHALLENGES AND SOLUTIONS IN DEVELOPING DRUG DELIVERY DEVICES FOR CHILDREN

“A CHILD IS NOT A SMALL ADULT”: CHALLENGES AND SOLUTIONS IN DEVELOPING DRUG DELIVERY DEVICES FOR CHILDREN

Tom Oakley and Heather Jameson consider the main differences in developing therapies and drug delivery devices for children and babies when compared with adults.

Product Showcase: CCBio’s Omega & Salus Pen Injectors

Product Showcase: CCBio’s Omega & Salus Pen Injectors

CCBio showcases two multidose injection devices with non-replaceable containers – the multi-dose pen, Omega, and the single-dose autoinjector, Salus.

ACQUIRING A LIQUID BIOPSY INCIDENTAL TO INTRAVITREAL INJECTION

Dr Alex Tumlinson

Twenty/Twenty Therapeutics

ACQUIRING A LIQUID BIOPSY INCIDENTAL TO INTRAVITREAL INJECTION

Alexandre Tumlinson introduces Twenty/Twenty Therapeutics' VitreoDx injection system to address emerging trends in intravitreal therapeutics.

NEEDLESTICK INJURY RISKS: SAFEGUARDING HEALTHCARE WORKERS AND PATIENTS

Dr Fred Metzmann

NEEDLESTICK INJURY RISKS: SAFEGUARDING HEALTHCARE WORKERS AND PATIENTS

Fred Metzmann discusses how using safety syringes can be a cost-effective measure to reduce the risk of injury to healthcare personnel and patients, and introduces the company’s devices designed for safer drug administration.

IN THE THICK OF IT: ACCELERATING THE MIXING AND DELIVERY OF HIGH-VISCOSITY INJECTABLES

Dr Brent Buchine

Windgap Medical

IN THE THICK OF IT: ACCELERATING THE MIXING AND DELIVERY OF HIGH-VISCOSITY INJECTABLES

Brent Buchine, Miriam Silton, Jameson Woods and Andrew Ryan explore how the combination of gas power and a side-by-side cartridge configuration increases the working viscosity range for the mixing and delivery of complex injectable formulations.

TECHNOLOGICAL ADVANCEMENTS TO OVERCOME VISCOSITY CHALLENGES FOR INJECTABLE DEVICES

TECHNOLOGICAL ADVANCEMENTS TO OVERCOME VISCOSITY CHALLENGES FOR INJECTABLE DEVICES

Joe Neale explores injectable drug development, delving into the intricacies of how technology is advancing to meet the challenges of administering complex formulations, enabling a more positive patient experience, promoting dosing compliance and maximising the benefits of these essential medicines.

GAS-POWERED AUTOINJECTOR PLATFORM ENABLES BIOLOGICS DRUG DELIVERY

GAS-POWERED AUTOINJECTOR PLATFORM ENABLES BIOLOGICS DRUG DELIVERY

Matt McCawley and Albie Lavin discuss Altaviz's universal biologics autoinjector platform, highlighting how its gas-powered drive system, based on Pico-Cylinders, provides numerous benefits over legacy spring-powered autoinjectors.

PICCOJECT – USING HUMAN FACTORS TO FULFIL PATIENTS’ NEED FOR INJECTION CONFIDENCE

PICCOJECT – USING HUMAN FACTORS TO FULFIL PATIENTS’ NEED FOR INJECTION CONFIDENCE

Thomas Thueer, Chris Muenzer and Ines Schlenker discuss the development of the enhanced usability features of PiccoJect, Haselmeier's novel autoinjector.

DEVICE INTERCHANGEABILITY STUDY OF THREE-STEP AND TWO-STEP AUTOINJECTORS

DEVICE INTERCHANGEABILITY STUDY OF THREE-STEP AND TWO-STEP AUTOINJECTORS

Alex Fong discusses the results of a study assessing patients’ ability to switch from a three-step autoinjector to a two-step device.

GX INBENEO<sup>®</sup> – DEVELOPING AN AUTOINJECTOR THAT RESPONDS TO THE CHALLENGES OF BIOLOGICS

Dr Daniel Primavessy

GX INBENEO^® – DEVELOPING AN AUTOINJECTOR THAT RESPONDS TO THE CHALLENGES OF BIOLOGICS

Daniel Primavessy, Sigrid Saaler-Reinhardt, Katarzyna Maksymowicz and Marie Stockton, Marketing Manager discuss how the Gx Inbeneo^® autoinjector from Gerresheimer was purpose designed to provide an effective, easy-to-use solution for the subcutaneous self-administration of sensitive biopharmaceuticals.

ACCELERATING ACCESS: THE FUTURE OF INJECTABLES IS PREFILLED AND PLASTIC – AN INTERVIEW WITH APIJECT’S BO KOWALCZYK & JON ELLENTHAL

ACCELERATING ACCESS: THE FUTURE OF INJECTABLES IS PREFILLED AND PLASTIC – AN INTERVIEW WITH APIJECT’S BO KOWALCZYK & JON ELLENTHAL

Bo Kowalczyk and Jon Ellenthal discuss the need for greater fill-finish capacity in the pharmaceutical industry highlighted by the covid-19 pandemic, and how ApiJect’s Blow-Fill-Seal prefilled injector platform aims to meet this need.

IDENTIFYING AND OVERCOMING THE CHALLENGES OF INJECTABLE COMBINATION PRODUCT EVOLUTION

IDENTIFYING AND OVERCOMING THE CHALLENGES OF INJECTABLE COMBINATION PRODUCT EVOLUTION

David DeSalvo considers some potential challenges that the rapid evolution of autoinjectors (and combination product injectables in general) raises, along with how the industry can successfully address this cycle of reinvention.

WHEN SECONDARY PACKAGING IS A PRIMARY CONCERN

INDUSTRIALISATION

WHEN SECONDARY PACKAGING IS A PRIMARY CONCERN

Mark Foster discusses the challenges to optimising primary and secondary packaging for parenteral drug delivery devices, including higher level challenges from the patient perspective, as well as how these challenges present opportunities for device developers to stand out in the market.

YPSODOSE – THE CLINIC-READY 10 ML PATCH INJECTOR

Christian Esser Wiesemann

YPSODOSE – THE CLINIC-READY 10 ML PATCH INJECTOR

Christian Esser Wiesemann provides the latest insights into the prefilled and pre-assembled YpsoDose patch injector, which is now available for clinical trials.

A NEW FRONTIER: SELF-ADMINISTRATION OF LYOPHILISED, LARGE-VOLUME SUBCUTANEOUS BIOLOGICS

Enable Injections

A NEW FRONTIER: SELF-ADMINISTRATION OF LYOPHILISED, LARGE-VOLUME SUBCUTANEOUS BIOLOGICS

Mehul Desai and Daniel Waites discuss the pros and cons of lyophilisation for biologic injectable drugs, and how Enable Injections’ enFuse device can provide an answer to the challenges of self-injection of large-volume and lyophilised biologics.

PRODUCT SHOWCASE: COMPLETE SYSTEM FOR STANDARD-COMPLIANT TESTING OF WEARABLE INJECTORS

PRODUCT SHOWCASE: COMPLETE SYSTEM FOR STANDARD-COMPLIANT TESTING OF WEARABLE INJECTORS

Specifically tailored to on-body delivery systems (OBDSs) / wearable injectors, ZwickRoell showcases its customised, comprehensive solution for performing functional tests in accordance with the ISO 11608-6 standard.

SUSTAINABLE DESIGN OF A DRUG DELIVERY DEVICE FOR BIOPHARMACEUTICALS

SUSTAINABLE DESIGN OF A DRUG DELIVERY DEVICE FOR BIOPHARMACEUTICALS

Maike Wolf and Marie Stockton discuss how sustainability is a fundamental strategic priority for Gerresheimer. They also highlight how eco-design principles have been applied to the development of an on-body injector for subcutaneous delivery of biopharmaceuticals.

COMPARISON OF MECHATRONIC VS MECHANICAL WEARABLE DRUG DELIVERY SYSTEMS

COMPARISON OF MECHATRONIC VS MECHANICAL WEARABLE DRUG DELIVERY SYSTEMS

Thomas Mayer, Nicolas Bailo and Martin Liniger highlight some of the key challenges that mechanical and mechatronic drug delivery systems must overcome when delivering large volumes of biologics subcutaneously and explain the solutions that Sonceboz has considered during the development process of the company’s large-volume injector.

EXTENDING PATIENT-FRIENDLY DRUG DELIVERY TO HIGH-VOLUME WEARABLE DEVICES

Dr Iris Schnitzler

EXTENDING PATIENT-FRIENDLY DRUG DELIVERY TO HIGH-VOLUME WEARABLE DEVICES

Iris Schnitzler discusses the benefits of on-body delivery systems, including the flexibility and convenience they bring to patients managing chronic conditions, and how the Sorrel platform overcomes some of the inherent complexities and challenges of developing such a device. Dr Schnitzler then goes on to speak with Bas van Buijtenen and Andrei Yosef about the Sorrel platform and how its integration within LTS supports the company’s fundamental objectives of enabling partners and empowering patients.

THE VERTIVA™ ON-BODY DELIVERY SYSTEM: EXPANDING OPPORTUNITIES IN HOME-BASED CARE

Stevanato Group

THE VERTIVA™ ON-BODY DELIVERY SYSTEM: EXPANDING OPPORTUNITIES IN HOME-BASED CARE

Adam Stops introduces Vertiva™, Stevanato Group’s next-generation on-body delivery system platform, and discusses how it meets the needs of pharma companies looking to deliver large-volume doses in a patient-centric manner.

CHRONIC PATIENTS AT THE CENTRE OF LARGE-VOLUME SC DELIVERY WITH A SUSTAINABLE ON-BODY INJECTOR

CHRONIC PATIENTS AT THE CENTRE OF LARGE-VOLUME SC DELIVERY WITH A SUSTAINABLE ON-BODY INJECTOR

Cécile Gross and Mark Tunkel discuss the role of patient-centricity in the development of Nemera’s sustainable on-body injector platform.

Technology Showcase: CCBio’s Felice Dose – Simplifying Subcutaneous Infusion

Technology Showcase: CCBio’s Felice Dose – Simplifying Subcutaneous Infusion

CCBio showcases Felice Dose, a revolutionary on-body injector (OBI) designed to address the challenges of traditional IV injections and SC drug administration.

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