INJECTABLE DRUG DELIVERY ARTICLES
Conducting A Medical Device Stability Study: A Practical Guide
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
INJECTABLE DRUG DELIVERY RESOURCES
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Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.
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The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."
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BD Physioject™ for Tirzepatide supports FDA ANDA submissions with proven usability, low error rates, and a design validated to match the reference listed autoinjector.
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Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.
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The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.
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An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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.
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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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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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The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.
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West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
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Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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Learn how Vertiva™ can enable delivery of micro-precision basal doses and full-content bolus injections, resulting in a highly flexible, customizable platform suitable for a wide range of therapies.
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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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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.