INJECTABLE DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-1462345800-robotics-vial-manufacturing]( "Robotics And AI In Pharma: Driving The Next Wave Of Innovation")
Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.
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![Pharma Manufacturing GettyImages-1135140594]( "Applying Automation To The Manufacture Of Drug Delivery Devices")
Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.
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![clinical-trial-tech-ai-GettyImages-2226144959]( "Device Design For Usability And Risk Reduction")
Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.
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![GettyImages-1316775813-vial-production]( "Lyophilized Products Are On The Rise: What You Need To Know")
There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.
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![Ozempic Insulin injection pen for diabetics-GettyImages-2112991930]( "Decoding the FDA Guidance on Essential Drug Delivery Outputs")
The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
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![vystra]( "BD Vystra™ Disposable Pen")
BD Vystra™ Disposable Pen is a proven, globally adopted drug delivery platform with over 175 million units sold, supporting diverse therapies in 40+ countries.
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![GettyImages-1335033345-cell-gene]( "How To Find The Right Balance In Cell Therapy Manufacturing")
The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![West-DELIV 2 - GC_App_^CZ vial with stopper and seal stack up]( "Proven Vial Containment That Scales From R&D To Commercial")
Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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![iStock-493302504-scientist-lab-development]( "Pre-Formulation And Material Sciences")
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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![GettyImages-1279969622-self-injector-injection]( "The Intersection Of Material Science And Medical Device Design")
Learn how leveraging our expertise in fundamental materials science and applied engineering can help you not only avoid failures but also resolve them swiftly through our Rapid Response process.
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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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![Singota-aseptic]( "Aseptic Manufacturing Services")
Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.
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![West-SBO 2 - GCApp_Instron]( "Freeze Your Device Design With An Integrated, Verified PFA System")
Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.
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![GettyImages-1964958878 glucose monitor wearables patient doctor]( "Putting More Within Reach")
A wearable subcutaneous injector is being developed to support delivery of large‑volume, complex biologic therapies, expanding options for patients needing advanced at‑home administration.
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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-1425605790 Life Sciences Training. Scientists Using A Computer In A Lab]( "Trusted Quality, Proven Expertise For Your Sterile Injectable")
Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable, powered by Pfizer’s global network of experts, reliability, and flexibility.
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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.
