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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Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
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Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.
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A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.
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Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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With a focus on the sustained and controlled drug delivery segment of the pharmaceutical market, learn about technology platforms, support services, and sustainable solutions.
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Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
INJECTABLE DRUG DELIVERY SOLUTIONS
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The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.
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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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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.
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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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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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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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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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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.
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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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West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.