INJECTABLE DRUG DELIVERY ARTICLES

teamwork, celebration, success, achievement-GettyImages-2215022093 Improving Drug-Device Combination Product Co-Development

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

INJECTABLE DRUG DELIVERY VIDEOS

Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.

INJECTABLE DRUG DELIVERY RESOURCES

INJECTABLE DRUG DELIVERY SOLUTIONS

  • Subcutaneous

    Low - Medium Viscosities
    < 100 cP
    1 - 10 ml

    High - Ultra-High Viscosities
    >100 - 10,000 cP
    0.5 - 3 ml

    ArQ® - 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.

  • 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.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.

  • Syngene's Sterile Fill-Finish facility is custom-built to meet market demand for clinical supplies, sterile drug products having short development timelines,

  • 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.

  • Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.

  • AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.

  • 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.

  • BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.