INJECTABLE DRUG DELIVERY ARTICLES
Formulation And Delivery Considerations For Cell And Gene Therapies
How can we ensure cell and gene therapies are truly transformative for patients? Success depends on the right combination of formulation, preparation, and delivery.
INJECTABLE DRUG DELIVERY RESOURCES
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Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.
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The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.
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Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.
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By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.
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The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.
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Explore the requirements of designing an autoinjector capable of handling the high pressures necessary for the delivery of highly viscous drug formulations with minimal impact on the patient.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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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.
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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
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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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We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.
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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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August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
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We can fill a wide range of container sizes and volumes in the clinical and commercial manufacturing of sterile injectables. Explore our capabilities in formulation and scale up, manufacturing, lyophilization, and extractables and leachables.
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Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.