INJECTABLE DRUG DELIVERY ARTICLES
Emerging RNA Delivery Strategies For Solid Tumor Oncology
RNA shows promise in solid tumors, but delivery remains the core challenge. New targeting and delivery strategies aim to overcome tumor barriers and unlock RNA’s full therapeutic potential.
INJECTABLE DRUG DELIVERY RESOURCES
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Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
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As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.
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Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.
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In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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A TheraPEA™ polymer based injectable formulation designed to deliver the same dose of Triamcinolone Acetonide (TAA) as in Zilretta® has shown promising results in a series of pre-clinical studies.
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Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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Subcutaneous
Low - Medium Viscosities
< 100 cP
1 - 10 mlHigh - Ultra-High Viscosities
>100 - 10,000 cP
0.5 - 3 mlArQ® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in less than 5 seconds. The ArQ-Bios platform also can deliver greater volumes than 1 ml subject to matching the formulation characteristics with acceptable patient tolerability.
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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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As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.
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Can your product be NanoImproved? Find out at at-a-glance with a 4-page informational spread covering new molecules and reformulations, small molecules and biologics, technology details, and proof points.
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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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Learn how leveraging our expertise in fundamental materials science and applied engineering can help you not only avoid failures but also resolve them swiftly through our Rapid Response process.
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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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This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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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.