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 RESOURCES
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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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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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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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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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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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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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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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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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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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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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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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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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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™ 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 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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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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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.