INJECTABLE DRUG DELIVERY ARTICLES
Risk Is the Spine: What The First 100 QMSR Inspections Reveal
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
INJECTABLE DRUG DELIVERY RESOURCES
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Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
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A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.
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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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These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
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This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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.
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Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
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A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.
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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 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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West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.
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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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Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.
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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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We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.