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| Redefining Prefillable Syringe Systems | A prefillable syringe platform streamlines early drug product development by providing an integrated, system-level approach to accelerate clinical fill. Built around a single verification package, compatibility assessments, aligned shipping formats, and system-level testing, it reduces development complexity and unnecessary testing. A structured documentation pathway guides teams from feasibility through regulatory submission, simplifying system selection, supporting consistent performance, and helping manufacturers bring safe, effective therapies to patients more efficiently. |
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Patient-Centric Drug Delivery: Do Possible And Preferable Align? | By Tom von Gunden, Chief Editor, Drug Delivery Leader | In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations with experts in drug delivery product development and with patients about the transition from clinically administered IV to subcutaneous injection, including self-administration. |
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By Fran DeGrazio, Senior Industry & Technical Advisor, Drug Delivery Leader | In this article, Fran DeGrazio discusses the transition from vial-based to prefilled syringe (PFS) delivery approaches. She lays out key differences and added complexities in areas such as device functionality, risk management, regulatory pathways, use of materials, lifecycle management, and organizational alignment. | |
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| A Smooth Transition To USP <382> With Established Expertise | Q&A | BD Medical - Pharmaceutical Systems | A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety. |
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| Safe Syringe Solutions For Lipid Nanoparticles | White Paper | Stevanato Group | Prefilled syringes improve lipid nanoparticle dosing accuracy and administration. Advanced containment solutions with cross-linked coatings preserve stability and accelerate development timelines. |
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| Unlocking The Promise Of NAMs | Article | By Bob Moyer, Battelle | NAMs are reshaping drug development by providing human-relevant insights that improve delivery candidate selection, reduce late-stage risk, and accelerate safer, more effective therapies. |
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