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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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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As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.
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Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.
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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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The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
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Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.
INJECTABLE DRUG DELIVERY SOLUTIONS
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A wearable subcutaneous injector is being developed to support delivery of large‑volume, complex biologic therapies, expanding options for patients needing advanced at‑home administration.
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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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Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.
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One of the few CDMOs offering sterile fill, device manufacturing, and final assembly at one site — combining expertise, scale, and flexibility for clinical, commercial, and niche production.
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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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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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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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Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.
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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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Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.