INJECTABLE DRUG DELIVERY ARTICLES
Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
Autologous intradiscal therapy integrates delivery and biology into one system, highlighting the potential of cell therapies in complex, localized disease environments.
INJECTABLE DRUG DELIVERY RESOURCES
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This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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Gain insight into the significant trends impacting the aseptic industry. This report focuses on key parenteral areas of aseptic manufacturing, scale-up, primary packaging options, and targeted treatments.
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Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.
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David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
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A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.
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Evaluating your system’s performance and compatibility earlier in development can ensure you have a viable product to support development phases.
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Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
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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Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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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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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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ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
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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.
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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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Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
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VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.