INJECTABLE DRUG DELIVERY ARTICLES
6 Packaging And Delivery Challenges For Biologic Therapies
In this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
INJECTABLE DRUG DELIVERY VIDEOS
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
INJECTABLE DRUG DELIVERY RESOURCES
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![GettyImages-1066989062-gene-cell-doctor-research]( "Vial Adapter Transfer Device Compatibility With Cell Therapies")
Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "Sterile Injectable Therapies: Revolutionizing Lifecycle Management")
The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.
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![GettyImages-1371707479-lab-mask-team-partnership]( "Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products")
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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![iStock-1319077865-lab-team-computer-research]( "Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk")
Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
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![Syringes GettyImages-171324030]( "Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation")
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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![GettyImages-949946968-lab-research]( "A Risk-Based Approach To Injectable Combination Product Development")
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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![Epigenetic therapies of the future_GettyImages-2203738408]( "Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing.")
By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![GettyImages-827582436-lab-samples-work-PPE]( "Sterile Fill-Finish Facility: Your Integrated Partner For Customized Clinical Supplies")
Syngene's Sterile Fill-Finish facility is custom-built to meet market demand for clinical supplies, sterile drug products having short development timelines,
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![C&G 2 - GCApp_MG (person picking up container)]( "Early Drug Development Made Easy With Small Quantities")
Why take the risk of selecting individual components that may not work well together? The West Ready Pack™ containment system, with proven container closure integrity, provides risk mitigation, convenience, and small quantities.
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![West-PFS SYRG-0178 NovaPure]( "An Integrated, Verified PFS System For Vaccines")
A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "BD Neopak™ XtraFlow™ Glass Prefillable Syringe")
A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.
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![BO 3 - GC_App_CZ Syringe and Vials_0171_RGB]( "Modeling Platform To De-Risk Container-Closure Selection")
West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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![West-1]( "Simplify The Journey With A Combination Product Solution")
Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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![StavanatoGroup-Vertiva On-Body Delivery System]( "Highly Flexible And Customizable On-Body Delivery System Platform")
Learn how Vertiva™ can enable delivery of micro-precision basal doses and full-content bolus injections, resulting in a highly flexible, customizable platform suitable for a wide range of therapies.
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![BD]( "Enabling The Delivery Of Complex Biologics With Ergonomic Solutions")
The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.
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![A-MICRO BI]( "Pharmaceutical Vial Filling Machine With Isolator")
Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.
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![denesting]( "Pharmaceutical De-Nesting Equipment For Syringes And Cartridges")
The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.
