INJECTABLE DRUG DELIVERY ARTICLES
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![GettyImages-1368429013-vial]( "Overcoming Challenges In Cell And Gene Therapy Containment")
Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
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![Vaccine Vial GettyImages-1216812369]( "Inspection Of Injectable Products For Visible Particulates")
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
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![Ozempic Insulin injection pen for diabetics-GettyImages-2112991930]( "Decoding the FDA Guidance on Essential Drug Delivery Outputs")
The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
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![GettyImages-1335033345-cell-gene]( "How To Find The Right Balance In Cell Therapy Manufacturing")
The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
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![West]( "USP <382>: Think Systems, Not Components")
This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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![Stevanato Group - Autoinjector Assembly Feature]( "How A Flexible Approach To Autoinjector Assembly Can Be Advantageous")
Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.
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![GettyImages-1294339649 drug development, cleanroom]( "How DFM Promotes Scalability, Repeatability, And Profitability")
Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![ASEPTiCell ScreenShot 3]( "Aseptic Filling Systems For Biopharmaceutical Manufacturing")
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.
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![West-DELIV 2 - GC_App_^CZ vial with stopper and seal stack up]( "Proven Vial Containment That Scales From R&D To Commercial")
Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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![West-PFS SYRG-0178 NovaPure]( "An Integrated, Verified PFS System For Vaccines")
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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![Lipid Nanoparticles GettyImages-1437855772]( "Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles")
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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![FillFinish_450x300]( "Fill Finish Solution - Maximize Drug Product Recovery")
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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![BD_Physioject_IMG_3332-450x300]( "BD Physioject™ Disposable Autoinjector")
BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.
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![GettyImages-1327623919-lab]( "Drug Product Services: Pre-Formulation To Commercial-Scale Production")
Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.
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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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![ypsoflow]( "Smart Connected Selfcare For The Prefilled YpsoFlow Pen")
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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.
