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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![Compliance GettyImages-1348548209]( "Annex 1 – The Brave New World Of Regulatory Compliance")
The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.
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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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![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.
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![GettyImages-525440891-lab-research-development]( "Making The Right Choice For Multiparticulate Modified Release Dosage Forms")
Wurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in modified release dosage forms. Understand if it's the right method for your modified-release project.
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![vystra liraglutide]( "De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions")
BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.
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![Syringes GettyImages-171324030]( "Key Considerations When Filling Dual Chamber Syringes")
Dual-chamber syringes (DCSs) are in high demand across the pharmaceutical and hospital industries. Learn about the challenges of the DCS filling manufacturing market and how to overcome them.
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![GettyImages-1346675538-lab-research-development-test tubes]( "Solubility With Lipid-Based Technologies For Oral & Injectable Formulations")
Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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![West_GC_App_PFS 1 mL 1_3mL Plungers 003 WestPharm_2_1ml_1-3ml_Plungers LR]( "Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success")
From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
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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.
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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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![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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![Medical Research-GettyImages-2162956896]( "Medical Device Solutions Fact Sheet")
Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.
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![BD_Physioject_IMG_3332-450x300]( "BD Physioject™ Disposable Autoinjector")
BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.
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![ASEPTiCell]( "Isolator Barrier Pharmaceutical Aseptic Filling Systems")
ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
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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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![GettyImages-1346675624-lab-research]( "Committed To Quality, Collaboration, Service And Innovation")
West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.
