INJECTABLE DRUG DELIVERY ARTICLES
Conducting A Medical Device Stability Study: A Practical Guide
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
INJECTABLE DRUG DELIVERY RESOURCES
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Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.
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Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).
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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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Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
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Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
INJECTABLE DRUG DELIVERY SOLUTIONS
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Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.
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AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
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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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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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With world-class facilities, the state-of-the-art equipment and some of the industry’s most talented people, you can feel confident that your small molecule drug product is in safe hands. Learning from decades working with other small molecules, INCOG has been purpose-built to provide better solutions for the global injectable drug product sector.
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Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.
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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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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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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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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.