INJECTABLE DRUG DELIVERY ARTICLES
Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
Cell therapy success depends on a durable implantation environment, making delivery and sustainability central to efficacy and functional outcomes.
INJECTABLE DRUG DELIVERY RESOURCES
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All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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Explore market trends that could impact the lifecycle strategies for your drug product and its packaging. Careful selection of drug packaging can save time and support a successful transition to new formats.
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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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Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.
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Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
INJECTABLE DRUG DELIVERY SOLUTIONS
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The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.
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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.
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A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.
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As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.
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Analyze a family of fill/finish solutions that offers a complete, configurable solution for biopharmas and CDMOs looking to maximize drug product recovery.
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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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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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One of the few CDMOs offering sterile fill, device manufacturing, and final assembly at one site — combining expertise, scale, and flexibility for clinical, commercial, and niche production.
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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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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.