INJECTABLE DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
INJECTABLE DRUG DELIVERY VIDEOS
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
INJECTABLE DRUG DELIVERY RESOURCES
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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
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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![GettyImages-1156884561-fill-finish]( "Key Considerations For Selecting Flexible Fillers")
Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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![GettyImages-1178834429-implant-chip-research-delivery]( "Implantable Drug Delivery: Are We There Yet?")
Implantable drug delivery offers precise, localized treatment, yet biological barriers and market complexities remain. Explore the factors determining if these systems are ready for broad adoption.
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![BD_Physioject_IMG_1404-450x300]( "De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions")
Discover an autoinjector platform that supports ANDA pathways with demonstrated usability and design alignment to help development teams reduce risk and move confidently toward regulatory submission.
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![GettyImages-1027752634]( "Selecting An Alternative Coating Technology To Silicone Oil For Prefillable Syringes")
The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.
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![GettyImages-949946968-lab-research]( "A Risk-Based Approach To Injectable Combination Product Development")
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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![Ready-To-Use GLP-1]( "Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs")
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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![Stevanato Group - Aidaptus]( "Aidaptus® Manufacturing")
We are the exclusive manufacturing partner for this innovative auto-injector platform.
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![GettyImages-1600719545 lab]( "Innovative Formulations And Higher Drug Loads Across The Life-Cycle")
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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![Stevanato]( "Automated Vision Inspection Systems For Injectable Drug Products: Vials, Syringes, Cartridges, Bottles")
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.
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![GettyImages-1187680243-biological-indicator-sterilization]( "Sterile Drug Product")
Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.
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![Getty Images-1087219418-fill-filling]( "Pharma Services Fill, Finish & Drug Delivery CDMO")
Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.
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![GettyImages-879828000-lab-cell-microscope]( "Analytical Services")
As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.
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![West-C&G 3 - 2mL_10mL_Vials_Tubs]( "Daikyo Crystal Zenith® Ready-To-Use Nested Vials")
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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![Capture]( "Injection Molding")
Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
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![StavanatoGroup-Vertiva On-Body Delivery System]( "Highly Flexible And Customizable On-Body Delivery System Platform")
Learn how Vertiva™ can enable delivery of micro-precision basal doses and full-content bolus injections, resulting in a highly flexible, customizable platform suitable for a wide range of therapies.
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![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
