INJECTABLE DRUG DELIVERY ARTICLES
Formulation And Delivery Considerations For Cell And Gene Therapies
How can we ensure cell and gene therapies are truly transformative for patients? Success depends on the right combination of formulation, preparation, and delivery.
INJECTABLE DRUG DELIVERY RESOURCES
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Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
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By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.
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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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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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Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.
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Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.
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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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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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Intramuscular
0.5 - 3 mlArQ® - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions. Built around Oval’s polymeric primary drug container technology, we can create a device that is small and simple to use, whilst housing the correct length needle to achieve consistent intramuscular delivery for your patient population.
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Why take the risk of selecting individual components that may not work well together? The West Ready Pack™ containment system, with proven container closure integrity, provides risk mitigation, convenience, and small quantities.
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Subcutaneous
Low - Medium Viscosities
< 100 cP
1 - 10 mlHigh - Ultra-High Viscosities
>100 - 10,000 cP
0.5 - 3 mlArQ® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in less than 5 seconds. The ArQ-Bios platform also can deliver greater volumes than 1 ml subject to matching the formulation characteristics with acceptable patient tolerability.
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Learn how leveraging our expertise in fundamental materials science and applied engineering can help you not only avoid failures but also resolve them swiftly through our Rapid Response process.
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West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.