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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In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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Fill‑finish is evolving as biologics and advanced therapies shift capacity and sterility needs. Automation, emerging tech, and data‑driven methods are boosting efficiency in aseptic production.
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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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The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
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The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs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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As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
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This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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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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Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
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Battelle, a leading nonprofit in applied science and technology, drives innovation in national security, healthcare, environment, and education while managing research labs and advancing critical discoveries.
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A scalable aseptic environment for diverse injectables, advanced automation, and Annex 1–aligned processes, supporting smooth transitions from development to commercial supply and long‑term strategy.
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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.
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Innovative technologies in the pharmaceutical industry are enabling a patient-centric approach in medicine. Auto-injectors provide an easy, convenient drug-delivery system for patient self-administration — improving compliance and dosage accuracy.
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Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.