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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Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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Aseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.
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Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
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Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.
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Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.
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Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.
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Optimize drug substance use during fill/finish. Learn how advanced line configurations and 100% non-destructive weight checks mitigate process drift, protect therapeutics, and prevent product loss.
INJECTABLE DRUG DELIVERY SOLUTIONS
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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.
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Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
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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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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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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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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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West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.
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The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.
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Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.