PREFILLED SYRINGES

PREFILLED SYRINGES

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

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

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.

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

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.

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

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.

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

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.

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.

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.

EXPERT VIEW

David DeSalvo

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.

INDUSTRIALISATION

Jennifer Riter

West Pharmaceutical Services

SUCCESSFUL INDUSTRIALISATION REQUIRES SOLID FOUNDATIONS

Jennifer Riter and Victoria Morgan discuss the importance of choosing the right containment system at the start for successful industrialisation of an injectable drug product.

CONNECTIVITY

Ali Badiei

Gerresheimer

DIGITAL TWIN IN THE PHARMACEUTICAL SUPPLY CHAIN

Gerresheimer’s Ali Badiei explains the role of digital twin technology and its integration into the pharmaceutical supply chain, highlighting an innovative approach to ensuring drug identity and quality.

INTERVIEW

Arnaud Guillet

Biocorp

Interview with Arnaud Guillet & Fanny Sellier

Arnaud Guillet and Fanny Sellier talk with Guy Furness about how Biocorp has become a key player in the field of connected drug delivery, discuss the current landscape for connectivity in drug delivery and update us on its two major parenteral products – Mallya and Injay – as well as looking forward to the launch of the company’s next generation of connected drug delivery solutions.

CONNECTIVITY

Finola Austin

Owen Mumford

HARNESSING HUMAN FACTORS IN CONNECTED DEVICE DEVELOPMENT

Finola Austin looks at the role human factors testing plays in the development of connected drug delivery devices.

EXPERT VIEW

Deepu Asok

STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS

Deepu Asok discusses the importance of test method validation for drug-device combination product development and how a common mistake is to design the validation process for a specific device rather than to accommodate the potential variety of a device platform.

INJECTION

Tomohiro Suzuki

Mitsubishi Gas Chemical

OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES

Tomohiro Suzuki reviews the advantages that OXYCAPT™, Mitsubishi Gas Chemical's multilayer material for vials, offers to biologics and gene and cell therapies, and discusses the results of recent tests into low-temperature storage and dimethyl sulfoxide resistance.

OCULAR

Yuki Takeuchi

Terumo Medical Care Solutions

OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION

Yuki Takeuchi and Richard Whelton discuss the challenges of delivering intravitreal injections and how the combination of Terumo’s PLAJEX™ prefillable syringes with Congruence’s Microlitre Dosing Syringe system is able to address them.

OCULAR

Dr Andrea Allmendinger

ten23 health

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Andrea Allmendinger and Hanns-Christian Mahler highlight the technical challenges of intravitreal administration and considerations from the ophthalmologist’s and patient’s perspectives.

INJECTION

Dr Brent Buchine

Windgap Medical

PATIENT-CENTRIC DESIGN CAN BE A FASTER PATH TO MARKET

Brent Buchine considers a faster path to market for automated and easy-to-use reconstitution devices through simplification of the delivery systems.

PREFILLED SYRINGES

Dr Iain Simpson

Phillips-Medisize

OPPORTUNITIES FOR INNOVATION WITH BIOSIMILARS

Iain Simpson and George Spooner investigate the use of drug delivery systems that support self-administration of biologic drugs, and specifically biosimilars, for the treatment of chronic diseases. This article is based on research conducted by both authors as part of the MPhil in Therapeutic Sciences at the University of Cambridge (UK) and supported by Phillips-Medisize.

INJECTION

Dr Shane Smith

Glycome BioPharma

Pro-Tects – A NOVEL SOLUTION TO THE CHALLENGE OF BIOLOGIC INSTABILITY

Shane Smith, Eoin Scanlan and Paula Colavita discusses the difficulty inherent in developing parenteral biologic products due to the challenge of creating a stable formulation in the face of surface-mediated protein aggregation and introduces Pro-Tects – Glycome’s patented surface-treatment technology platform that offers a solution to this critical issue without introducing further development challenges.

INDUSTRIALISATION

Peter Schmidt

ZwickRoell

PRODUCT SHOWCASE: New Requirements for Injection Devices Make Advanced Testing Solutions Necessary

ZwickRoell showcases its advanced testing solutions for injection devices including pens, autoinjectors and on-body delivery systems.

PREFILLED SYRINGES

Yasuaki Yoshimura

Mitsubishi Gas Chemical

OXYCAPT: SUPERIOR PRIMARY CONTAINERS FOR BIOLOGICS AND GENE AND CELL THERAPIES

Yasuaki Yoshimura and Tomohiro Suzuki review the advantages that OXYCAPT, the company’s multilayer material for vials, offers to biologics and gene and cell therapies, and discuss the results of recent tests into low temperature storage and dimethyl sulfoxide resistance.

INTERVIEW

Guy Furness

Kymanox

Interview: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen

Mathias Romacker, Fran DeGrazio and Paul Jansen sit down with Guy Furness, to discuss what it is that has driven Kymanox’s rapid rise in the drug delivery space and what makes the consulting company’s model so successful, as well as to share their expertise on a variety of topics in an illuminating discussion, including connectivity, how large and small drug developers engage with consultancies, 5 mL autoinjectors and the interface between drug primary packaging and delivery devices.

PREFILLED SYRINGES

Bernd Zeiss

Gerresheimer

SILICONE-OIL-FREE PREFILLED SYRINGE SYSTEMS – GUIDANCE FOR SELECTING THE APPROPRIATE PACKAGING MATERIALS AND FOR SILICONISATION

Bernd Zeiss addresses the influence of silicone oil on syringe systems and highlights the advantages and possibilities of novel silicone-oil-free prefillable syringes, both for glass and for plastic syringes.

INTERVIEW

Guy Furness

Aptar Pharma

Interview: Gabriel Zenker, Aptar Pharma

Gabriel Zenker talks with ONdrugDelivery about Aptar Pharma’s ambitions for the parenterals sector. Mr Zenker explains how Aptar, already a major player in the pulmonary, nasal, ophthalmic and dermal markets, is undertaking a major expansion of its facilities, boosting the company’s capacity, capabilities and technologies, to provide its extensive service and product offering to the exciting injectables space.

PREFILLED SYRINGES

Asmita Khanolkar

SMC Ltd

ACCELERATING NOVEL THERAPIES TO THE CLINIC – CUSTOM SOLUTIONS

Asmita Khanolkar discusses the key offerings necessary to accelerate “speed to clinic” for custom manufacturing solutions.

PREFILLED SYRINGES

Dr Andrea Allmendinger

ten23 health

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

Andrea Allmendinger and Hanns-Christian Mahler both at ten23 health, provide an insight into the challenges of integrated development of drug product and device design and fill-finish manufacturing operations.

PREFILLED SYRINGES

Sebastian Block

Scherdel Medtec North America

A TALE OF TWO SPRINGS

Sebastian Block and Drew Jelgerhuis introduce two types of springs and highlight their important role in drug delivery devices.

INJECTION

Silvia Gallina

Stevanato Group

ENGINEERING ADVANCES IN NEEDLE GEOMETRY TO ACCOMMODATE VISCOUS BIOLOGICS

Silvia Gallina discusses the challenges faced in administering highly viscous biologics to patients via subcutaneous injection, and how Stevanato Group’s new special thin-wall needles are able to tackle them.

INJECTION

Victoria Morgan

West Pharmaceutical Services

BEING PREPARED FOR PHARMA INNOVATION IS KEY IN 2023

Victoria Morgan and Ana Marques Kuschel discuss three recent innovations that West Pharmaceutical Services has introduced to enable its partners to respond to specific market-driven challenges, from pandemic-driven pressures on fill-finish productivity to the underlying shift towards biologics and the accelerated growth of home-based treatment.