INJECTABLE DRUG DELIVERY ARTICLES
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
INJECTABLE DRUG DELIVERY RESOURCES
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Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.
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Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
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A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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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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Current component technologies for cartridge-based drug delivery pose challenges. In order to address these challenges, the next generation of cartridge components are evolving.
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When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.
INJECTABLE DRUG DELIVERY SOLUTIONS
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The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.
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Ypsomed accelerates clinical progress by reducing barriers across clinical development, enabling earlier study readiness, greater visibility and more informed decisions.
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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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Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.
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We are the exclusive manufacturing partner for this innovative auto-injector platform.
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The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.
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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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West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.
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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.