Prefilled Syringes & Injection Devices152

Issue No #152 Oct 2023 October 9th, 2023

Inside the magazine

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.

AUTOINJECTORS FOR LARGE-VOLUME SUBCUTANEOUS DRUG DELIVERY

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.

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.

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.

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.

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.

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

INDUSTRIALISATION

Enrico Barichello

Stevanato Group

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.

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.

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