INJECTABLE DRUG DELIVERY ARTICLES
Intratumoral Treatment Of Cancer: After Many Prior Attempts, Has The Time Finally Come?
Several companies are in Phase 3 development of intratumoral drug products, all with a lead product in a cancer other than melanoma, based on novel chemistry.
INJECTABLE DRUG DELIVERY RESOURCES
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When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.
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Current component technologies for cartridge-based drug delivery pose challenges. In order to address these challenges, the next generation of cartridge components are evolving.
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What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?
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Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
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Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.
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Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
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CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
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West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.
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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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Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
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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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Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.
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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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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.