INJECTABLE DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
INJECTABLE DRUG DELIVERY RESOURCES
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The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
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In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.
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Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.
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Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
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Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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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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Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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.
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A look at integrated drug‑delivery expertise, scalable development paths, and advanced manufacturing that speed programs from formulation to global launch while reducing risk and improving efficiency.
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Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.
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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.
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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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Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
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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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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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Emergency‑readiness programs strengthen response with dependable countermeasures, rapid‑action tools, and decades of expertise supporting teams facing chemical, biological, and other high‑risk threats.