INJECTABLE DRUG DELIVERY ARTICLES
Conducting A Medical Device Stability Study: A Practical Guide
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
INJECTABLE DRUG DELIVERY RESOURCES
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Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
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Jeff Clement, Executive Director, CDMO Business Development North America, discusses the impact of the pandemic on CDMOs and parenteral market trends.
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The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.
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Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
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Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.
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This study investigates the suitability of a container system composed of the novel COP CZ as an alternative for the ultra-cold storage of therapeutically relevant AAV viral vectors.
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As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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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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Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable, powered by Pfizer’s global network of experts, reliability, and flexibility.
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As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).
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Syngene's Sterile Fill-Finish facility is custom-built to meet market demand for clinical supplies, sterile drug products having short development timelines,
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Learn how a CDMO with robust processes and specialized technologies like automated fill lines can help you speed to market while maintaining consistently high quality of your product.
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Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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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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Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.