INJECTABLE DRUG DELIVERY ARTICLES
Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
While circular RNA platforms can enhance protein expression, developing effective delivery strategies remains the key challenge to achieving therapeutic efficacy.
INJECTABLE DRUG DELIVERY RESOURCES
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Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.
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Growing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements.
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Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
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A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety.
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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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Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).
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Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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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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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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The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.
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A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.
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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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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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West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.
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Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.