INJECTABLE DRUG DELIVERY ARTICLES
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
INJECTABLE DRUG DELIVERY RESOURCES
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A TheraPEA™ polymer based injectable formulation designed to deliver the same dose of Triamcinolone Acetonide (TAA) as in Zilretta® has shown promising results in a series of pre-clinical studies.
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As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.
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Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.
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See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
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As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.
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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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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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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This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.
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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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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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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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Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.
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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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Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.