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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All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.
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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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This technology addresses workforce shortages and growing medical complexity by helping healthcare providers manage rising demands, improve efficiency, reduce errors, and extend care access.
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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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When it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.
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Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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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. In short, we consistently make the insoluble soluble.
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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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An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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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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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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AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.
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Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.