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PFS
WEARABLES
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OCULAR
ORAL
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PULMONARY
NASAL
ALL RESPIRATORY
MORE
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Prefilled Syringes & Injection Devices
152
Issue No #152 Oct 2023
October 9th, 2023
Download PDF
Issue 152 - Oct 2023
Inside the magazine
INDUSTRIALISATION
Edwin Hendrawan
SHL Medical
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
Jeff Henderson
Vetter Pharma
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.
INJECTION
Ian Thompson
Ypsomed
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
Claire Raynal-Olive
Aptar Pharma
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.
INDUSTRIALISATION
Dr Dave Seaward
3P Innovation
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.
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.
INDUSTRIALISATION
Michele Guasti
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
Dr Doug Bryans
Bryllan
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.
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.
PREFILLED SYRINGES
Edouard Pagnoud
Aptar Pharma
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.
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.
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.
INJECTION
Pauline Koyanagi
ZACROS
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.
EXPERT VIEW
Tom Oakley
“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.
INJECTION
Jimmy Fan
CC Bio
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.
EARLY INSIGHT
Dr Alex Tumlinson
ACQUIRING A LIQUID BIOPSY INCIDENTAL TO INTRAVITREAL INJECTION
Alexandre Tumlinson introduces Twenty/Twenty Therapeutics' VitreoDx injection system to address emerging trends in intravitreal therapeutics.
INJECTION
Dr Fred Metzmann
Roncadelle
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.
DUAL CHAMBER
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.
INJECTION
Joe Neale
Recipharm
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.
INJECTION
Matt McCawley
Altaviz
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.
INJECTION
Thomas Thueer
Haselmeier
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.
INJECTION
Alex Fong
Owen Mumford
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.
INJECTION
Dr Daniel Primavessy
Midas Pharma
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.
INTERVIEW
Bo Kowalczyk
ApiJect
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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