INJECTABLE DRUG DELIVERY ARTICLES
Designing Nanoparticles: Why Size Comes First
Successful nanoparticle programs choose size intentionally, taking into consideration the physical, chemical, and biological consequences of size.
INJECTABLE DRUG DELIVERY RESOURCES
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By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
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BD Vystra™ Disposable Pen is a proven, globally adopted drug delivery platform with over 175 million units sold, supporting diverse therapies in 40+ countries.
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Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
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Read the second part of this series on the most common questions encountered by an expert focused in scientific affairs and technical solutions for glass.
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Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.
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As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.
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NAM adoption is constrained by inconsistent cell sourcing, limited standardization, and regulatory uncertainty — barriers that must be addressed to enable reproducible evidence and regulatory trust.
INJECTABLE DRUG DELIVERY SOLUTIONS
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By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
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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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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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An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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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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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.