INJECTABLE DRUG DELIVERY ARTICLES
Navigating Combination Products: Device Complexity And Software Integration
Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-1131587509-syringe-vial-injection-inspection]( "USP <788> Revisions And Why Packaging Matters More Than Ever")
Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "Prefilled Syringes Market Trends: Improving Patient Experience")
Learn how sterile injectable devices are providing safer and more convenient self-injection delivery, leading to positive patient experiences, better therapy adherence, and improved outcomes.
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![BO 2 - GC_App_^CZ vial with stopper and seal stack up]( "Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization")
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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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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![IPC-filling]( "Aseptic Filling And Processing Considerations For Biosimilars")
One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.
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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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![BD Medical - Libertas Feature]( "Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics")
Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![Stevanato Group - Aidaptus]( "Aidaptus® Manufacturing")
We are the exclusive manufacturing partner for this innovative auto-injector platform.
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![iStock-1057830102-gloves-lab-sample]( "Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials")
Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.
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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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![chemistry-tech-center-GettyImages-1417397137]( "Battelle's Chemistry Technical Center (CTC)")
Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.
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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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![BIMI]( "Aseptic Filling System For Pharmaceuticals: BI-MI")
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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![iStock-640282108-fill-equipment-finish]( "cGMP Aseptic Manufacturing And Sterile Fill-Finish")
Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.
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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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![leading-cdmo-GettyImages-1417391937]( "A Leading Drug Delivery CDMO")
A look at integrated drug‑delivery expertise, scalable development paths, and advanced manufacturing that speed programs from formulation to global launch while reducing risk and improving efficiency.
