INJECTABLE DRUG DELIVERY ARTICLES
Injecting Cancer Killers: Intratumoral Therapy For Solid Tumors
Intratumoral injection bypasses the tumor’s physical defenses entirely, killing cancer cells and creating a personalized immune response that destroys solid tumors.
INJECTABLE DRUG DELIVERY RESOURCES
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Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.
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Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
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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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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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This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.
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Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.
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The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options.
INJECTABLE DRUG DELIVERY SOLUTIONS
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We are the exclusive manufacturing partner for this innovative auto-injector platform.
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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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Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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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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Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
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Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable, powered by Pfizer’s global network of experts, reliability, and flexibility.
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Innovative technologies in the pharmaceutical industry are enabling a patient-centric approach in medicine. Auto-injectors provide an easy, convenient drug-delivery system for patient self-administration — improving compliance and dosage accuracy.
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BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
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Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.