INJECTABLE DRUG DELIVERY ARTICLES
A Case Study: Control Strategies For A Multi-Dose Pen Injector
A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
INJECTABLE DRUG DELIVERY RESOURCES
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Learn how sterile injectable devices are providing safer and more convenient self-injection delivery, leading to positive patient experiences, better therapy adherence, and improved outcomes.
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GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.
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Bridgeton's sterile site unites advanced filling tech, integrated quality, and scalable capacity to streamline complex injectables, reduce risk, and support efficient progress to commercial supply.
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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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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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Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.
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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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).
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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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Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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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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Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.
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Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.
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A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.
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BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
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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.